Trial Outcomes & Findings for Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex (NCT NCT01965067)
NCT ID: NCT01965067
Last Updated: 2014-08-15
Results Overview
The time from the administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C and 35°C, and compared with the normal thermal condition.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
The recovery time to the TOF ratio of 0.9 after the administration of the sugammadex, an expected average of 5 minutes
Results posted on
2014-08-15
Participant Flow
Participant milestones
| Measure |
C Group
normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
H Group
mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex
Baseline characteristics by cohort
| Measure |
H Group
n=30 Participants
mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
C Group
n=30 Participants
normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
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
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The recovery time to the TOF ratio of 0.9 after the administration of the sugammadex, an expected average of 5 minutesThe time from the administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C and 35°C, and compared with the normal thermal condition.
Outcome measures
| Measure |
C Group
n=30 Participants
normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
H Group
n=30 Participants
mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
|---|---|---|
|
Reversal Time of Rocuronium
|
124.9 seconds
Standard Deviation 59.2
|
171.1 seconds
Standard Deviation 62.1
|
SECONDARY outcome
Timeframe: 1 min before reversal, 1 min after reversal, 1 day after surgeryFrom the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, mean arterial blood pressure at 1 min before reversal(pre-reversal), 1 min after reversal(post-reversal), recovery and 1 day after surgery (post-anesthetic visit).
Outcome measures
| Measure |
C Group
n=30 Participants
normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
H Group
n=30 Participants
mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
|---|---|---|
|
Mean Arterial Blood Pressure
Mean arterial pressure at 1 min before reversal
|
89.9 mmHg
Standard Deviation 10.6
|
91.6 mmHg
Standard Deviation 9.1
|
|
Mean Arterial Blood Pressure
Mean arterial pressure at 1 min after reversal
|
88.4 mmHg
Standard Deviation 10.5
|
89.6 mmHg
Standard Deviation 10.1
|
|
Mean Arterial Blood Pressure
Mean arterial pressure at 3 min after reversal
|
87.5 mmHg
Standard Deviation 11.5
|
90.2 mmHg
Standard Deviation 13.7
|
|
Mean Arterial Blood Pressure
Mean arterial pressure at 1 day after surgery
|
95.0 mmHg
Standard Deviation 12.4
|
94.6 mmHg
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 1 min before reversal, 1 min after reversal, 1 day after surgeryFrom the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, Heart rate at 1 min before reversal(pre-reversal), 1 min after reversal(post-reversal), recovery and 1 day after surgery (post-anesthetic visit).
Outcome measures
| Measure |
C Group
n=30 Participants
normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
H Group
n=30 Participants
mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
|---|---|---|
|
Heart Rate
Heart rate at 1 min before reversal
|
77.5 beats/min
Standard Deviation 10.4
|
77.8 beats/min
Standard Deviation 8.7
|
|
Heart Rate
Heart rate at 1 min after reversal
|
71.8 beats/min
Standard Deviation 10
|
72.9 beats/min
Standard Deviation 9.1
|
|
Heart Rate
Heart rate at 3 min after reversal
|
70.7 beats/min
Standard Deviation 10
|
73.1 beats/min
Standard Deviation 9.1
|
|
Heart Rate
Heart rate at 1 day after reversal
|
81.6 beats/min
Standard Deviation 13.9
|
84.2 beats/min
Standard Deviation 14.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During 1day after operationOutcome measures
| Measure |
C Group
n=30 Participants
normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
H Group
n=30 Participants
mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
|---|---|---|
|
Incidence of Residual Neuromuscular Blockade
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During 7days after operationOutcome measures
| Measure |
C Group
n=30 Participants
normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
H Group
n=30 Participants
mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
|---|---|---|
|
Post-operative Nausea and Vomiting
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During 7days after operationadverse effect of sugammadex(hypersensitivity, dry mouth, hypertension etc.)
Outcome measures
| Measure |
C Group
n=30 Participants
normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
H Group
n=30 Participants
mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
|
|---|---|---|
|
Adverse Events
|
0 participants
|
0 participants
|
Adverse Events
C Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
H 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
Kyo Sang Kim, MD, PhD
Department of Anesthesiology and Pain Medicine, Hanyang University Hospital
Phone: +82-2-2290-8680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place