Trial Outcomes & Findings for The Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy (NCT NCT02100280)
NCT ID: NCT02100280
Last Updated: 2024-01-10
Results Overview
Blood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 6.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
96 participants
Primary outcome timeframe
1 hr after the end of operation
Results posted on
2024-01-10
Participant Flow
Participant milestones
| Measure |
Deep Block
Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
|
Moderate Block
Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
COMPLETED
|
44
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy
Baseline characteristics by cohort
| Measure |
Deep Block
n=48 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
|
Moderate Block
n=48 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
|
Total
n=96 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
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 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
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 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
|
|
stress response
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hr after the end of operationBlood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 6.
Outcome measures
| Measure |
Deep Block
n=44 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
|
Moderate Block
n=44 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
|
|---|---|---|
|
IL-6
|
84 pg / ml
Standard Deviation 96.98
|
70.14 pg / ml
Standard Deviation 99.15
|
SECONDARY outcome
Timeframe: 30min before end of operationBlood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of TNF-α.
Outcome measures
| Measure |
Deep Block
n=44 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
|
Moderate Block
n=44 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
|
|---|---|---|
|
TNF-α
|
1.33 pg / ml
Standard Deviation 0.71
|
1.66 pg / ml
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: 30min before end of operationBlood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of IL-1β.
Outcome measures
| Measure |
Deep Block
n=44 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
|
Moderate Block
n=44 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
|
|---|---|---|
|
IL-1β
|
0.34 pg / ml
Standard Deviation 0.55
|
0.27 pg / ml
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: 1 hr after end of operationBlood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 8.
Outcome measures
| Measure |
Deep Block
n=44 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
|
Moderate Block
n=44 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
|
|---|---|---|
|
IL-8
|
29.6 pg / ml
Standard Deviation 13.9
|
29.5 pg / ml
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: 48 hr after end of operationBlood samples are collected from the antecubital vein of the arm not used for IV infusion 48 hr after the end of operation for analysis of CRP.
Outcome measures
| Measure |
Deep Block
n=44 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
|
Moderate Block
n=44 Participants
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed 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.
|
|---|---|---|
|
CRP
|
12.2 pg / ml
Standard Deviation 6.4
|
10.6 pg / ml
Standard Deviation 5.6
|
Adverse Events
Deep Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Block
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