Trial Outcomes & Findings for Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures (NCT NCT02451202)
NCT ID: NCT02451202
Last Updated: 2020-01-07
Results Overview
Proportion of patients who have a excellent and good surgical condition score
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
102 participants
Primary outcome timeframe
intraoperative
Results posted on
2020-01-07
Participant Flow
Participant milestones
| Measure |
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).
Deep 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
|
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.
Moderate 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.
Sugammadex
Rocuronium
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
49
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures
Baseline characteristics by cohort
| Measure |
Deep Neuromuscular Blockade Arm
n=49 Participants
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).
|
Moderate Neuromuscular Blockade Arm
n=48 Participants
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.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.31 Year
STANDARD_DEVIATION 13.28 • n=5 Participants
|
43.5 Year
STANDARD_DEVIATION 11.78 • n=7 Participants
|
43.03 Year
STANDARD_DEVIATION 12.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
22.07 "kg/m^2"
STANDARD_DEVIATION 5.15 • n=5 Participants
|
23.75 "kg/m^2"
STANDARD_DEVIATION 3.66 • n=7 Participants
|
23.03 "kg/m^2"
STANDARD_DEVIATION 4.35 • n=5 Participants
|
PRIMARY outcome
Timeframe: intraoperativeProportion of patients who have a excellent and good surgical condition score
Outcome measures
| Measure |
Moderate Neuromuscular Blockade Arm
n=48 Participants
Moderate 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.
|
Deep Neuromuscular Blockade Arm
n=49 Participants
Deep 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.
|
|---|---|---|
|
Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions
|
0.89 Proportion of patients
|
1 Proportion of patients
|
SECONDARY outcome
Timeframe: Minutes 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.
Outcome measures
| Measure |
Moderate Neuromuscular Blockade Arm
n=49 Participants
Moderate 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.
|
Deep Neuromuscular Blockade Arm
n=48 Participants
Deep 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.
|
|---|---|---|
|
Time to Modified Aldrete's Score ≥ 9
|
27 Minutes
Interval 14.0 to 42.0
|
33 Minutes
Interval 18.0 to 48.0
|
Adverse Events
Deep Neuromuscular Blockade Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Neuromuscular Blockade Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Prok Laosuwan
Department of Anesthesiology, King Chulalongkorn Memorial Hospital
Phone: +66 2256 4295
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place