FindTrial
Sign In

Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures

A Comparison of Surgical Conditions Between Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02451202
Enrollment
102
Registered
2015-05-21
Start date
2016-06-30
Completion date
2018-03-31
Last updated
2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngoscopic Surgical Procedures

Keywords

surgical conditions, deep neuromuscular blockade, deep neuromuscular paralysis

Brief summary

It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex as an reversal in endolaryngeal surgery. We will conduct a clinical study aiming to compare two treatment strategies; Deep neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB will offer better stillness. We will also descriptively examine if patients would be safely discharged from a recovery room.

Interventions

PROCEDUREDeep Neuromuscular Blockade

* During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2). * At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by Sugammadex 4mg/kg from PTC 1-2.

PROCEDUREModerate Neuromuscular Blockade

\- During maintenance phase, if recovery at the presence of \<10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour.

DRUGSugammadex
DRUGRocuronium

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Male or female aged 18 - 60 years; ASA I-III. * Subjects have been planned for elective endolaryngeal. Procedures (Direct Laryngoscopy with laser (micro-)surgery in patients with Tis, T1, T2, supraglottis and glottis carcinoma)

Exclusion criteria

* Any renal impairment (CrCL \< 80 ml/ min) * Any hepatic impairment; Child Pugh A, B or C * BMI \> 30 kg m2 * Known or suspected generalized neuromuscular disorders * Allergies to Rocuronium, Sugammadex, Sevoflurane, Propofol, fentanyl used during general anesthesia * Hypersensitivity to the active substance or to any of the excipients * Female patient who are pregnant and breastfeeding. * Patient with poor Glasgow Coma Score and mental derangement who is unable to give informed consent. * Patient with Tracheostomy tube.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients Who Have a Clinically Acceptable Surgical ConditionsintraoperativeProportion of patients who have a excellent and good surgical condition score

Secondary

MeasureTime frameDescription
Time to Modified Aldrete's Score ≥ 9Minutes from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU.Time from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU by Modified Aldrete's score assessment which scale range is from 0-10. Higher value represents a better outcome.

Participant flow

Participants by arm

ArmCount
Deep Neuromuscular Blockade Arm
After initial doses of 0.6 mg Rocuronium, a continuous infusion can be initiated to maintain 0 responses to train-of-four (TOF) stimulation or 1-2 responses to Post-Tetanic Count (PTC) (Deep NMB). The pump rate will vary and depends on the PTC value. The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required PTC value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthetist. Deep NMB should be maintained throughout the operation. The infusion of Rocuronium will be discontinued and Sugammadex will be given 4 mg/kg at the end of surgery, which is from deep NMB (PTC = 1-2).
49
Moderate Neuromuscular Blockade Arm
After evidence of early spontaneous recovery (\< 10% of control T1) from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain 1 to 2 responses to train-of-four stimulation (Moderate NMB). The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required TOF value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthesiologist. Moderate paralysis should be maintained throughout an operation. At the end of surgery, the infusion of Rocuronium will be discontinued and Sugammadex 2 mg/kg via bolus injections\]will be administered at least reappearance of T2.
48
Total97

Baseline characteristics

CharacteristicDeep Neuromuscular Blockade ArmModerate Neuromuscular Blockade ArmTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
49 Participants48 Participants97 Participants
Age, Continuous42.31 Year
STANDARD_DEVIATION 13.28
43.5 Year
STANDARD_DEVIATION 11.78
43.03 Year
STANDARD_DEVIATION 12.42
BMI22.07 kg/m^2
STANDARD_DEVIATION 5.15
23.75 kg/m^2
STANDARD_DEVIATION 3.66
23.03 kg/m^2
STANDARD_DEVIATION 4.35
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
49 Participants48 Participants97 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
23 Participants20 Participants43 Participants
Sex: Female, Male
Male
26 Participants28 Participants54 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 490 / 48
other
Total, other adverse events
0 / 490 / 48
serious
Total, serious adverse events
0 / 490 / 48

Outcome results

Primary

Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions

Proportion of patients who have a excellent and good surgical condition score

Time frame: intraoperative

ArmMeasureValue (NUMBER)
Moderate Neuromuscular Blockade ArmProportion of Patients Who Have a Clinically Acceptable Surgical Conditions0.89 Proportion of patients
Deep Neuromuscular Blockade ArmProportion of Patients Who Have a Clinically Acceptable Surgical Conditions1 Proportion of patients
Secondary

Time to Modified Aldrete's Score ≥ 9

Time from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU by Modified Aldrete's score assessment which scale range is from 0-10. Higher value represents a better outcome.

Time frame: Minutes from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU.

ArmMeasureValue (MEDIAN)
Moderate Neuromuscular Blockade ArmTime to Modified Aldrete's Score ≥ 927 Minutes
Deep Neuromuscular Blockade ArmTime to Modified Aldrete's Score ≥ 933 Minutes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026