Neuromuscular Blockade
Conditions
Brief summary
This study aims to make a comparison of surgical condition and recovery time between rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.
Detailed description
This study aims to make a comparison of surgical condition and recovery time between moderate neuromuscular bloackade with reversal using neostigmine group and deep neuromuscular bloackade with reversal using sugammadex group.
Interventions
OTHERInjection of neostigmine or sugammadex
At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation. During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologist Physical status classification 1 or 2 elective laryngeal microsurgery under general anesthesia
Exclusion criteria
* BMI \>25 or \< 20 kg/m2 Patients taking intercurrent medication Glutamic Oxalacetate Transaminase or Glutamic Pyruvate Transaminase \> 40 IU/L, Cr \> 1.4 mg/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laryngoscopic Score | At the beginning of surgery, the surgeon rated the laryngoscopy condition | Definitions for evaluation of Laryngoscopycondition. : Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy. Variables Excellent Good Poor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Time From Neuromuscular Blockade | from the injection of neostigmine or sugammadex up to 30 minutes | We measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rocuronium 0.45 - Neostigmine when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.
When the end of operation, a injection of neostigmine or sugammadex will be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected. | 22 |
| Rocuronium 0.9 - Sugammadex When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.
When the end of operation,, a injection of neostigmine or sugammadex be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected. | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | Rocuronium 0.45 - Neostigmine | Rocuronium 0.9 - Sugammadex | Total |
|---|---|---|---|
| Age, Categorical Population from 18 years to 65 years <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Population from 18 years to 65 years >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Population from 18 years to 65 years Between 18 and 65 years | 22 Participants | 22 Participants | 44 Participants |
| Race/Ethnicity, Customized Number of South Korean participants | 22 Participants | 22 Participants | 44 Participants |
| Region of Enrollment Korea, Republic of | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Laryngoscopic Score
Definitions for evaluation of Laryngoscopycondition. : Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy. Variables Excellent Good Poor
Time frame: At the beginning of surgery, the surgeon rated the laryngoscopy condition
Population: Definitions for evaluation of Laryngoscopycondition.~: Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.~Variables Excellent Good Poor
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rocuronium 0.45 - Neostigmine | Laryngoscopic Score | Difficult | 1 Participants |
| Rocuronium 0.45 - Neostigmine | Laryngoscopic Score | Fair | 11 Participants |
| Rocuronium 0.45 - Neostigmine | Laryngoscopic Score | Easy | 9 Participants |
| Rocuronium 0.9 - Sugammadex | Laryngoscopic Score | Difficult | 0 Participants |
| Rocuronium 0.9 - Sugammadex | Laryngoscopic Score | Fair | 0 Participants |
| Rocuronium 0.9 - Sugammadex | Laryngoscopic Score | Easy | 19 Participants |
p-value: 0.05t-test, 2 sided
Secondary
Recovery Time From Neuromuscular Blockade
We measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9
Time frame: from the injection of neostigmine or sugammadex up to 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rocuronium 0.45 - Neostigmine | Recovery Time From Neuromuscular Blockade | 9.9 minute | Standard Deviation 4 |
| Rocuronium 0.9 - Sugammadex | Recovery Time From Neuromuscular Blockade | 2.1 minute | Standard Deviation 0.6 |
p-value: 0.05t-test, 2 sided