Trial Outcomes & Findings for Deep Neuromuscular Block for Laparoscopic Surgery (NCT NCT03034577)
NCT ID: NCT03034577
Last Updated: 2020-04-22
Results Overview
The primary outcome will be the cognitive domain at 1 week after surgery, when it is expected that most of the acute inflammation will have resolved, and analgesia requirements minimal.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
350 participants
Primary outcome timeframe
1 week
Results posted on
2020-04-22
Participant Flow
In the period from June 2017 until November 2018, 350 patients were enrolled across 4 hospital sites (100 patients from the Royal Melbourne Hospital, 98 from the Peter MacCallum Cancer Centre, 88 from the Royal Women's Hospital and 64 from North Park Private Hospital).
No participants were excluded from the study prior to surgical procedure
Participant milestones
| Measure |
Moderate Neuromuscular Blockade Reversed With Neostigmine
The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF \> 2.
Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.
Extubation occurred when the TOF = 4 with no visible fade.
|
Deep Neuromuscular Blockade Reversed With Sugammadex
The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.
Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.
Extubation occurred when the TOF=4 with no visible fade.
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
175
|
|
Overall Study
COMPLETED
|
144
|
140
|
|
Overall Study
NOT COMPLETED
|
31
|
35
|
Reasons for withdrawal
| Measure |
Moderate Neuromuscular Blockade Reversed With Neostigmine
The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF \> 2.
Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.
Extubation occurred when the TOF = 4 with no visible fade.
|
Deep Neuromuscular Blockade Reversed With Sugammadex
The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.
Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.
Extubation occurred when the TOF=4 with no visible fade.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
9
|
|
Overall Study
Lost to Follow-up
|
25
|
26
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Moderate Neuromuscular Blockade Reversed With Neostigmine
n=175 Participants
The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF \> 2.
Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.
Extubation occurred when the TOF = 4 with no visible fade.
|
Deep Neuromuscular Blockade Reversed With Sugammadex
n=175 Participants
The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.
Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.
Extubation occurred when the TOF=4 with no visible fade.
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 16.3 • n=175 Participants
|
54.4 years
STANDARD_DEVIATION 15.5 • n=175 Participants
|
54.5 years
STANDARD_DEVIATION 15.9 • n=350 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=175 Participants
|
79 Participants
n=175 Participants
|
181 Participants
n=350 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=175 Participants
|
96 Participants
n=175 Participants
|
169 Participants
n=350 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Australia
|
175 participants
n=175 Participants
|
175 participants
n=175 Participants
|
350 participants
n=350 Participants
|
|
ASA Status
ASA I
|
24 Participants
n=168 Participants • Missing data Moderate block = 7 Deep block = 3
|
30 Participants
n=172 Participants • Missing data Moderate block = 7 Deep block = 3
|
54 Participants
n=340 Participants • Missing data Moderate block = 7 Deep block = 3
|
|
ASA Status
ASA II
|
99 Participants
n=168 Participants • Missing data Moderate block = 7 Deep block = 3
|
104 Participants
n=172 Participants • Missing data Moderate block = 7 Deep block = 3
|
203 Participants
n=340 Participants • Missing data Moderate block = 7 Deep block = 3
|
|
ASA Status
ASA III
|
45 Participants
n=168 Participants • Missing data Moderate block = 7 Deep block = 3
|
38 Participants
n=172 Participants • Missing data Moderate block = 7 Deep block = 3
|
83 Participants
n=340 Participants • Missing data Moderate block = 7 Deep block = 3
|
|
BMI
|
29.5 kg/m^2
STANDARD_DEVIATION 6.0 • n=175 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 6.1 • n=175 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 6.0 • n=350 Participants
|
|
Education
|
13.5 years
STANDARD_DEVIATION 4.0 • n=175 Participants
|
13.3 years
STANDARD_DEVIATION 3.4 • n=175 Participants
|
13.4 years
STANDARD_DEVIATION 3.5 • n=350 Participants
|
|
Alcohol consumption
|
4.8 units/week
STANDARD_DEVIATION 8.1 • n=175 Participants
|
3.9 units/week
STANDARD_DEVIATION 6.3 • n=175 Participants
|
4.3 units/week
STANDARD_DEVIATION 7.2 • n=350 Participants
|
|
Previous smoker
|
85 Participants
n=175 Participants
|
86 Participants
n=175 Participants
|
171 Participants
n=350 Participants
|
|
Current Smoker
|
24 Participants
n=175 Participants
|
15 Participants
n=175 Participants
|
39 Participants
n=350 Participants
|
|
Employment
|
93 Participants
n=175 Participants
|
114 Participants
n=175 Participants
|
207 Participants
n=350 Participants
|
|
Surgical access
Laparoscopic surgery
|
125 Participants
n=175 Participants
|
131 Participants
n=175 Participants
|
256 Participants
n=350 Participants
|
|
Surgical access
Robotic-assisted
|
50 Participants
n=175 Participants
|
44 Participants
n=175 Participants
|
94 Participants
n=350 Participants
|
|
Out-patient
|
12 Participants
n=175 Participants
|
13 Participants
n=175 Participants
|
25 Participants
n=350 Participants
|
|
Anaesthetic technique
General anaesthesia
|
164 Participants
n=175 Participants
|
164 Participants
n=175 Participants
|
328 Participants
n=350 Participants
|
|
Anaesthetic technique
Spinal anaesthesia
|
11 Participants
n=175 Participants
|
9 Participants
n=175 Participants
|
20 Participants
n=350 Participants
|
|
Anaesthetic technique
Regional block
|
0 Participants
n=175 Participants
|
2 Participants
n=175 Participants
|
2 Participants
n=350 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 31 participants who did not complete the cognitive assessment at 1 week in the moderate neuromuscular blockade group, whereas there were 35 participants who did not complete the cognitive assessment at 1 week in the deep neuromuscular blockade group
The primary outcome will be the cognitive domain at 1 week after surgery, when it is expected that most of the acute inflammation will have resolved, and analgesia requirements minimal.
Outcome measures
| Measure |
Moderate Neuromuscular Blockade Reversed With Neostigmine
n=144 Participants
The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF \> 2.
Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.
Extubation occurred when the TOF = 4 with no visible fade.
|
Deep Neuromuscular Blockade Reversed With Sugammadex
n=140 Participants
The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.
Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.
Extubation occurred when the TOF=4 with no visible fade.
|
|---|---|---|
|
Percentage of Patients Recovered Cognitively at 1 Week
|
91.8 percentage of patients recovered
|
92.9 percentage of patients recovered
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Recovery in all domains of the Postoperative Quality of Recovery Scale at 3 months after the operation
Recovery for all domains and within domains of the PostopQRS scale at the other time points of measurement (15 minutes, 40 minutes 1 day, 3 days, 1 and 2 weeks, and 3 months following cessation of anesthesia). The domains of recovery are physiological, nociceptive, emotive activities of daily living, cognitive and overall patient perspective.
Outcome measures
| Measure |
Moderate Neuromuscular Blockade Reversed With Neostigmine
n=175 Participants
The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF \> 2.
Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.
Extubation occurred when the TOF = 4 with no visible fade.
|
Deep Neuromuscular Blockade Reversed With Sugammadex
n=175 Participants
The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.
Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.
Extubation occurred when the TOF=4 with no visible fade.
|
|---|---|---|
|
Percentage of Patients Recovered in All Domains of the Postoperative Quality of Recovery Scale at 3 Months After the Operation
|
75.7 percentage of patients recovered
|
73 percentage of patients recovered
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: Full reversal prior to extubation (4 twitches and TOF ratio \>0.9)
Compliance with protocol to ensure deep block or light/moderate block, using the train of four ratio and post tetanic count
Outcome measures
| Measure |
Moderate Neuromuscular Blockade Reversed With Neostigmine
n=175 Participants
The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF \> 2.
Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.
Extubation occurred when the TOF = 4 with no visible fade.
|
Deep Neuromuscular Blockade Reversed With Sugammadex
n=175 Participants
The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.
Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.
Extubation occurred when the TOF=4 with no visible fade.
|
|---|---|---|
|
Number of Participants With Full Reversal of Neuromuscular Blockade Prior to Extubation
|
158 participants
|
161 participants
|
SECONDARY outcome
Timeframe: Up to 6 hoursPopulation: Duration of Anesthesia from induction to cessation of the anesthetic
Duration of Anesthesia from induction to cessation of the anesthetic up to 6 hours
Outcome measures
| Measure |
Moderate Neuromuscular Blockade Reversed With Neostigmine
n=175 Participants
The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF \> 2.
Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.
Extubation occurred when the TOF = 4 with no visible fade.
|
Deep Neuromuscular Blockade Reversed With Sugammadex
n=175 Participants
The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.
Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.
Extubation occurred when the TOF=4 with no visible fade.
|
|---|---|---|
|
Duration of Anesthesia From Induction to Cessation of the Anesthetic
|
165.4 minutes
Standard Deviation 88.8
|
164 minutes
Standard Deviation 96
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Surgical operating conditions
Overall surgical satisfaction using a 1-5 Likert scale (1 = very unacceptable, 2 = unacceptable, 3 = acceptable, 4 = good, 5 = excellent).
Outcome measures
| Measure |
Moderate Neuromuscular Blockade Reversed With Neostigmine
n=166 Participants
The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF \> 2.
Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.
Extubation occurred when the TOF = 4 with no visible fade.
|
Deep Neuromuscular Blockade Reversed With Sugammadex
n=165 Participants
The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.
Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.
Extubation occurred when the TOF=4 with no visible fade.
|
|---|---|---|
|
Number of Participants Categorized by Level of Surgical Satisfaction
Excellent
|
104 participants
|
94 participants
|
|
Number of Participants Categorized by Level of Surgical Satisfaction
Good
|
38 participants
|
48 participants
|
|
Number of Participants Categorized by Level of Surgical Satisfaction
Acceptable
|
20 participants
|
16 participants
|
|
Number of Participants Categorized by Level of Surgical Satisfaction
Unacceptable
|
3 participants
|
1 participants
|
|
Number of Participants Categorized by Level of Surgical Satisfaction
Very Unacceptable
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Duration of hospital length of stay following their procedure until hospital discharge
Duration of hospital length of stay following their procedure until hospital discharge
Outcome measures
| Measure |
Moderate Neuromuscular Blockade Reversed With Neostigmine
n=175 Participants
The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF \> 2.
Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.
Extubation occurred when the TOF = 4 with no visible fade.
|
Deep Neuromuscular Blockade Reversed With Sugammadex
n=175 Participants
The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.
Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.
Extubation occurred when the TOF=4 with no visible fade.
|
|---|---|---|
|
Duration of Hospital Length of Stay
|
2.6 days
Standard Deviation 3.5
|
1.8 days
Standard Deviation 1.9
|
Adverse Events
Moderate Neuromuscular Blockade Reversed With Neostigmine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deep Neuromuscular Blockade Reversed With Sugammadex
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place