Anesthesia, General
Conditions
Brief summary
The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg neostigmine.
Interventions
DRUGSugammadex
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered
DRUGNeostigmine
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is of American Society of Anesthesiologists (ASA) 1 - 4; * Is above or equal to the age of 18; * Scheduled for surgical procedures with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block; * Scheduled for surgical procedure in supine position; * Given written informed consent.
Exclusion criteria
* Participants in whom a difficult intubation because of anatomical malformations was expected; * Is known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction; * Is known or suspected to have a (family) history of malignant hyperthermia; * Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia; * Is receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+; * Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated; * Had already participated in a sugammadex trial; * Had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into P05960. * Females who are pregnant: * Females of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control; * Females who were breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9. | Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 | Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 | Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB. |
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 | Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB. |
| Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Day 1 | After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness |
| Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Day 1 | Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness |
Participant flow
Recruitment details
Participants who had a surgical procedure using a general anesthesia of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Rocuronium + Sugammadex After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered | 48 |
| Rocuronium + Neostigmine After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered | 48 |
| Vecuronium + Sugammadex After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered | 48 |
| Vecuronium + Neostigmine After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered | 45 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 1 |
| Overall Study | Not Treated | 1 | 1 | 3 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Rocuronium + Sugammadex | Rocuronium + Neostigmine | Vecuronium + Sugammadex | Vecuronium + Neostigmine | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51 Years STANDARD_DEVIATION 16 | 48 Years STANDARD_DEVIATION 14 | 49 Years STANDARD_DEVIATION 16 | 50 Years STANDARD_DEVIATION 15 | 49 Years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 7 Participants | 8 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 39 Participants | 41 Participants | 37 Participants | 160 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 46 Participants | 48 Participants | 48 Participants | 45 Participants | 187 Participants |
| Sex: Female, Male Female | 17 Participants | 24 Participants | 22 Participants | 24 Participants | 87 Participants |
| Sex: Female, Male Male | 31 Participants | 24 Participants | 26 Participants | 21 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 | 0 / 48 | 0 / 45 |
| other Total, other adverse events | 37 / 48 | 40 / 48 | 32 / 48 | 35 / 45 |
| serious Total, serious adverse events | 2 / 48 | 3 / 48 | 0 / 48 | 0 / 45 |
Outcome results
Primary
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
Time frame: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9
Population: All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rocuronium + Sugammadex | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9. | 1.62 Minutes | Standard Deviation 0.83 |
| Rocuronium + Neostigmine | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9. | 26.78 Minutes | Standard Deviation 24.6 |
| Vecuronium + Sugammadex | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9. | 4.47 Minutes | Standard Deviation 9.28 |
| Vecuronium + Neostigmine | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9. | 23.43 Minutes | Standard Deviation 18.53 |
Secondary
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room
Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness
Time frame: Day 1
Population: All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. One participant from the Rocuronium + Sugammadex treatment group, and one participant from the Vecuronium + Neostigmine treatment group were not analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rocuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Able to perform the 5 second head lift | 47 Participants |
| Rocuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Arousable with minimal stimulation | 1 Participants |
| Rocuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Has general muscle weakness | 0 Participants |
| Rocuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Responsive only to tactile stimuli | 0 Participants |
| Rocuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Awake and oriented | 46 Participants |
| Rocuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Responsive only to tactile stimuli | 0 Participants |
| Rocuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Able to perform the 5 second head lift | 48 Participants |
| Rocuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Has general muscle weakness | 0 Participants |
| Rocuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Arousable with minimal stimulation | 0 Participants |
| Rocuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Awake and oriented | 48 Participants |
| Vecuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Responsive only to tactile stimuli | 0 Participants |
| Vecuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Awake and oriented | 48 Participants |
| Vecuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Arousable with minimal stimulation | 0 Participants |
| Vecuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Able to perform the 5 second head lift | 48 Participants |
| Vecuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Has general muscle weakness | 0 Participants |
| Vecuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Able to perform the 5 second head lift | 44 Participants |
| Vecuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Arousable with minimal stimulation | 1 Participants |
| Vecuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Awake and oriented | 43 Participants |
| Vecuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Consciousness: Responsive only to tactile stimuli | 0 Participants |
| Vecuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Has general muscle weakness | 0 Participants |
Secondary
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation
After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness
Time frame: Day 1
Population: All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rocuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Awake and oriented | 30 Participants |
| Rocuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Able to perform the 5 second head lift | 38 Participants |
| Rocuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Responsive only to tactile stimuli | 2 Participants |
| Rocuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Has general muscle weakness | 3 Participants |
| Rocuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Arousable with minimal stimulation | 16 Participants |
| Rocuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Has general muscle weakness | 9 Participants |
| Rocuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Awake and oriented | 35 Participants |
| Rocuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Arousable with minimal stimulation | 13 Participants |
| Rocuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Responsive only to tactile stimuli | 0 Participants |
| Rocuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Able to perform the 5 second head lift | 37 Participants |
| Vecuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Arousable with minimal stimulation | 17 Participants |
| Vecuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Awake and oriented | 29 Participants |
| Vecuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Has general muscle weakness | 4 Participants |
| Vecuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Able to perform the 5 second head lift | 40 Participants |
| Vecuronium + Sugammadex | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Responsive only to tactile stimuli | 2 Participants |
| Vecuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Has general muscle weakness | 6 Participants |
| Vecuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Responsive only to tactile stimuli | 5 Participants |
| Vecuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Able to perform the 5 second head lift | 32 Participants |
| Vecuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Awake and oriented | 26 Participants |
| Vecuronium + Neostigmine | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | Consciousness: Arousable with minimal stimulation | 14 Participants |
Secondary
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
Time frame: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7
Population: All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rocuronium + Sugammadex | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 | 1.17 Minutes | Standard Deviation 0.4 |
| Rocuronium + Neostigmine | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 | 9.60 Minutes | Standard Deviation 8.23 |
| Vecuronium + Sugammadex | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 | 1.68 Minutes | Standard Deviation 0.57 |
| Vecuronium + Neostigmine | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 | 9.52 Minutes | Standard Deviation 10.15 |
Secondary
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
Time frame: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8
Population: All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rocuronium + Sugammadex | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 | 1.32 Minutes | Standard Deviation 0.48 |
| Rocuronium + Neostigmine | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 | 15.32 Minutes | Standard Deviation 14.38 |
| Vecuronium + Sugammadex | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 | 2.12 Minutes | Standard Deviation 0.87 |
| Vecuronium + Neostigmine | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 | 15.33 Minutes | Standard Deviation 13.37 |