Trial Outcomes & Findings for The Effect of Deep Neuromuscular Block on Surgical Condition During Laparoscopic Colorectal Surgery (NCT NCT02580188)
NCT ID: NCT02580188
Last Updated: 2019-03-13
Results Overview
Intra-abdominal pressure was maintained at 12 mmHg during pneumoperitoneum(using the carbon dioxide gas insufflation) and the pressure alarm for IAP was set at \< 15 mmHg. Intra-abdominal pressure is measured in a separate machine connected to a carbon dioxide gas injection line.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
intraoperative, an averrage of 3 hour
Results posted on
2019-03-13
Participant Flow
Participant milestones
| Measure |
Group M
Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
|
Group D
Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
sugammadex: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Deep Neuromuscular Block on Surgical Condition During Laparoscopic Colorectal Surgery
Baseline characteristics by cohort
| Measure |
Group M
n=35 Participants
Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
|
Group D
n=35 Participants
Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
sugammadex: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
41 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: intraoperative, an averrage of 3 hourIntra-abdominal pressure was maintained at 12 mmHg during pneumoperitoneum(using the carbon dioxide gas insufflation) and the pressure alarm for IAP was set at \< 15 mmHg. Intra-abdominal pressure is measured in a separate machine connected to a carbon dioxide gas injection line.
Outcome measures
| Measure |
Moderate Block
n=32 Participants
Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
|
Deep Block
n=32 Participants
Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
sugammadex: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
|
|---|---|---|
|
Number of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHg
|
14 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24hr after end of operationPostoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.
Outcome measures
| Measure |
Moderate Block
n=32 Participants
Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
|
Deep Block
n=32 Participants
Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
sugammadex: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
|
|---|---|---|
|
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)
|
4.5 score on a scale
Interval 1.0 to 7.0
|
4 score on a scale
Interval 0.0 to 8.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48hr after end of operationPostoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.
Outcome measures
| Measure |
Moderate Block
n=32 Participants
Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
|
Deep Block
n=32 Participants
Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
sugammadex: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
|
|---|---|---|
|
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)
|
3 score on a scale
Interval 0.0 to 8.0
|
2 score on a scale
Interval 0.0 to 7.0
|
Adverse Events
Group M
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D
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