Trial Outcomes & Findings for Effectiveness of Sugammadex in LMS Surgery (NCT NCT02329964)
NCT ID: NCT02329964
Last Updated: 2015-09-28
Results Overview
we measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.
Recruitment status
UNKNOWN
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minutes
Results posted on
2015-09-28
Participant Flow
Recruitment period : 2015.2.10 - 2015.6.30 Location : Korea University Medical Center Anam Hospital
Participant milestones
| Measure |
R-S Group
Rocuronium-Sugammadex group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Rocuronium 1mg/kg
3. After endotracheal intubation
* normal saline(0.025 ml/kg)
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Rocuronium 0.15mg/kg
5. Relaxant agent reversal. at the the end of surgery.
* sugammadex 2mg/kg
|
S-C-N Group
Succinylcholine-Cisatracurium-Neostigmine group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Succinylcholine 1mg/kg
3. After endotracheal intubation,
* Cisatracurium 0.08mg/kg
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Succinylcholine 10mg
5. Relaxant agent reversal. at the appearance of second TOF twitch (T2).
* Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Sugammadex in LMS Surgery
Baseline characteristics by cohort
| Measure |
R-S Group
n=40 Participants
Rocuronium-Sugammadex group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Rocuronium 1mg/kg
3. After endotracheal intubation
* normal saline(0.025 ml/kg)
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Rocuronium 0.15mg/kg
5. Relaxant agent reversal. at the the end of surgery.
* sugammadex 2mg/kg
|
S-C-N Group
n=40 Participants
Succinylcholine-Cisatracurium-Neostigmine group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Succinylcholine 1mg/kg
3. After endotracheal intubation,
* Cisatracurium 0.08mg/kg
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Succinylcholine 10mg
5. Relaxant agent reversal. at the appearance of second TOF twitch (T2).
* Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 12 • n=93 Participants
|
52 years
STANDARD_DEVIATION 15 • n=4 Participants
|
50 years
STANDARD_DEVIATION 13 • n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minuteswe measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.
Outcome measures
| Measure |
R-S Group
n=40 Participants
Rocuronium-Sugammadex group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Rocuronium 1mg/kg
3. After endotracheal intubation
* normal saline(0.025 ml/kg)
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Rocuronium 0.15mg/kg
5. Relaxant agent reversal. at the the end of surgery.
* sugammadex 2mg/kg
|
S-C-N Group
n=40 Participants
Succinylcholine-Cisatracurium-Neostigmine group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Succinylcholine 1mg/kg
3. After endotracheal intubation,
* Cisatracurium 0.08mg/kg
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Succinylcholine 10mg
5. Relaxant agent reversal. at the appearance of second TOF twitch (T2).
* Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
|
|---|---|---|
|
Recovery of T1 to 90%
|
377 seconds
Interval 334.0 to 435.0
|
240 seconds
Interval 180.0 to 360.0
|
PRIMARY outcome
Timeframe: during surgerydescribe by surgeon under his subjective opinion. 1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions
Outcome measures
| Measure |
R-S Group
n=40 Participants
Rocuronium-Sugammadex group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Rocuronium 1mg/kg
3. After endotracheal intubation
* normal saline(0.025 ml/kg)
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Rocuronium 0.15mg/kg
5. Relaxant agent reversal. at the the end of surgery.
* sugammadex 2mg/kg
|
S-C-N Group
n=40 Participants
Succinylcholine-Cisatracurium-Neostigmine group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Succinylcholine 1mg/kg
3. After endotracheal intubation,
* Cisatracurium 0.08mg/kg
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Succinylcholine 10mg
5. Relaxant agent reversal. at the appearance of second TOF twitch (T2).
* Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
|
|---|---|---|
|
Surgical Rating Score
|
5.0 score
Interval 5.0 to 5.0
|
5.0 score
Interval 4.0 to 5.0
|
PRIMARY outcome
Timeframe: during surgeryRepeated small boluses or drip of Succinylcholine, or small boluses of nondepolarizing muscle relaxants with intermediate duration are usually followed. In this protocol, cisatracurium was injected after intubation to maintain neuromuscular blockade during surgery. We measure the requirement of additive dose of neuromuscular blocker to ensure that neuromuscular blockade remains below T2 during surgery
Outcome measures
| Measure |
R-S Group
n=40 Participants
Rocuronium-Sugammadex group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Rocuronium 1mg/kg
3. After endotracheal intubation
* normal saline(0.025 ml/kg)
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Rocuronium 0.15mg/kg
5. Relaxant agent reversal. at the the end of surgery.
* sugammadex 2mg/kg
|
S-C-N Group
n=40 Participants
Succinylcholine-Cisatracurium-Neostigmine group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Succinylcholine 1mg/kg
3. After endotracheal intubation,
* Cisatracurium 0.08mg/kg
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Succinylcholine 10mg
5. Relaxant agent reversal. at the appearance of second TOF twitch (T2).
* Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
|
|---|---|---|
|
Addition of Neuromuscular Blocking Agents
|
0 participants
|
20 participants
|
PRIMARY outcome
Timeframe: from the end of surgery to time when the TOF ratio is 0.1, up to 30 minuteswe measure the time from the end of surgery to recovery of the TOF 0.1. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.
Outcome measures
| Measure |
R-S Group
n=40 Participants
Rocuronium-Sugammadex group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Rocuronium 1mg/kg
3. After endotracheal intubation
* normal saline(0.025 ml/kg)
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Rocuronium 0.15mg/kg
5. Relaxant agent reversal. at the the end of surgery.
* sugammadex 2mg/kg
|
S-C-N Group
n=40 Participants
Succinylcholine-Cisatracurium-Neostigmine group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Succinylcholine 1mg/kg
3. After endotracheal intubation,
* Cisatracurium 0.08mg/kg
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Succinylcholine 10mg
5. Relaxant agent reversal. at the appearance of second TOF twitch (T2).
* Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
|
|---|---|---|
|
Recovery of T1 to 10%
|
271 seconds
Interval 183.0 to 330.0
|
190 seconds
Interval 105.0 to 300.0
|
SECONDARY outcome
Timeframe: from the end of surgery to extubate a tracheal tubeWe expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to recovery of the TOF 0.9, and the time from the end of surgery to extubation
Outcome measures
| Measure |
R-S Group
n=40 Participants
Rocuronium-Sugammadex group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Rocuronium 1mg/kg
3. After endotracheal intubation
* normal saline(0.025 ml/kg)
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Rocuronium 0.15mg/kg
5. Relaxant agent reversal. at the the end of surgery.
* sugammadex 2mg/kg
|
S-C-N Group
n=40 Participants
Succinylcholine-Cisatracurium-Neostigmine group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Succinylcholine 1mg/kg
3. After endotracheal intubation,
* Cisatracurium 0.08mg/kg
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Succinylcholine 10mg
5. Relaxant agent reversal. at the appearance of second TOF twitch (T2).
* Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
|
|---|---|---|
|
Time to Extubation
|
430 seconds
Interval 366.0 to 510.0
|
380 seconds
Interval 286.0 to 495.0
|
SECONDARY outcome
Timeframe: from end of surgery to first spontaneous breathstime from end of surgery to first spontaneous breaths
Outcome measures
| Measure |
R-S Group
n=40 Participants
Rocuronium-Sugammadex group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Rocuronium 1mg/kg
3. After endotracheal intubation
* normal saline(0.025 ml/kg)
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Rocuronium 0.15mg/kg
5. Relaxant agent reversal. at the the end of surgery.
* sugammadex 2mg/kg
|
S-C-N Group
n=40 Participants
Succinylcholine-Cisatracurium-Neostigmine group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Succinylcholine 1mg/kg
3. After endotracheal intubation,
* Cisatracurium 0.08mg/kg
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Succinylcholine 10mg
5. Relaxant agent reversal. at the appearance of second TOF twitch (T2).
* Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
|
|---|---|---|
|
Time to First Spontaneous Breath
|
263 seconds
Interval 175.0 to 334.0
|
240 seconds
Interval 70.0 to 325.0
|
SECONDARY outcome
Timeframe: from end of surgery to opening of the eyes to verbal commandsWe expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to opening of the eyes to verbal commands.
Outcome measures
| Measure |
R-S Group
n=40 Participants
Rocuronium-Sugammadex group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Rocuronium 1mg/kg
3. After endotracheal intubation
* normal saline(0.025 ml/kg)
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Rocuronium 0.15mg/kg
5. Relaxant agent reversal. at the the end of surgery.
* sugammadex 2mg/kg
|
S-C-N Group
n=40 Participants
Succinylcholine-Cisatracurium-Neostigmine group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Succinylcholine 1mg/kg
3. After endotracheal intubation,
* Cisatracurium 0.08mg/kg
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Succinylcholine 10mg
5. Relaxant agent reversal. at the appearance of second TOF twitch (T2).
* Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
|
|---|---|---|
|
Time to Eye Opening
|
340 seconds
Interval 200.0 to 517.0
|
300 seconds
Interval 180.0 to 420.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: time from in to out of the operating roomLMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group.
Outcome measures
| Measure |
R-S Group
n=40 Participants
Rocuronium-Sugammadex group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Rocuronium 1mg/kg
3. After endotracheal intubation
* normal saline(0.025 ml/kg)
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Rocuronium 0.15mg/kg
5. Relaxant agent reversal. at the the end of surgery.
* sugammadex 2mg/kg
|
S-C-N Group
n=40 Participants
Succinylcholine-Cisatracurium-Neostigmine group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Succinylcholine 1mg/kg
3. After endotracheal intubation,
* Cisatracurium 0.08mg/kg
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Succinylcholine 10mg
5. Relaxant agent reversal. at the appearance of second TOF twitch (T2).
* Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
|
|---|---|---|
|
Length of Stay in te Operating Room
|
31.0 minutes
Standard Deviation 7.7
|
38.6 minutes
Standard Deviation 7.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from the anesthesia start to endtime from propofol injection to extubation
Outcome measures
| Measure |
R-S Group
n=40 Participants
Rocuronium-Sugammadex group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Rocuronium 1mg/kg
3. After endotracheal intubation
* normal saline(0.025 ml/kg)
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Rocuronium 0.15mg/kg
5. Relaxant agent reversal. at the the end of surgery.
* sugammadex 2mg/kg
|
S-C-N Group
n=40 Participants
Succinylcholine-Cisatracurium-Neostigmine group
1. Induction agent :
* IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
2. During induction of anesthesia, as muscle relaxant agent
* Succinylcholine 1mg/kg
3. After endotracheal intubation,
* Cisatracurium 0.08mg/kg
4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
* Succinylcholine 10mg
5. Relaxant agent reversal. at the appearance of second TOF twitch (T2).
* Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
|
|---|---|---|
|
Anesthesia Time
|
28.4 minutes
Standard Deviation 7.5
|
35.2 minutes
Standard Deviation 7.0
|
Adverse Events
R-S Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
S-C-N Group
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