Trial Outcomes & Findings for Optimal Dose of Combination of Rocuronium and Cisatracurium (NCT NCT02495038)
NCT ID: NCT02495038
Last Updated: 2018-03-02
Results Overview
Time from administration of initial NMBAs to Train-of-four (TOF) ratio=0, assessed up to 15 minutes during general anesthesia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Intraoperative, an average of 5 minutes
Results posted on
2018-03-02
Participant Flow
Participant milestones
| Measure |
Intubating Dose, Group I
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Dose of Combination of Rocuronium and Cisatracurium
Baseline characteristics by cohort
| Measure |
Intubating Dose, Group I
n=27 Participants
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 Participants
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 Participants
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
81 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Intraoperative, an average of 5 minutesTime from administration of initial NMBAs to Train-of-four (TOF) ratio=0, assessed up to 15 minutes during general anesthesia.
Outcome measures
| Measure |
Intubating Dose, Group I
n=27 Participants
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 Participants
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 Participants
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
|---|---|---|---|
|
Onset of Neuromuscular Blocking Agents(NMBAs)
|
212.8 Second
Standard Deviation 56.0
|
230.1 Second
Standard Deviation 60.6
|
399.3 Second
Standard Deviation 147.8
|
PRIMARY outcome
Timeframe: Intraoperative, an average of 1 hoursTime from administration of initial NMBAs to Train-of-four (TOF) ratio \>25%, assessed up to 2 hours during general anesthesia.
Outcome measures
| Measure |
Intubating Dose, Group I
n=27 Participants
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 Participants
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 Participants
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
|---|---|---|---|
|
Duration 25% of Neuromuscular Blocking Agents(NMBAs)
|
51.3 Minute
Standard Deviation 8.4
|
47.9 Minute
Standard Deviation 10.7
|
39.4 Minute
Standard Deviation 6.8
|
PRIMARY outcome
Timeframe: Intraoperative, an average of 20 minutesTime from TOF ratio 25% to 75%, assessed up to 1 hour during general anesthesia.
Outcome measures
| Measure |
Intubating Dose, Group I
n=27 Participants
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 Participants
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 Participants
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
|---|---|---|---|
|
Recovery Index of Neuromuscular Blocking Agents(NMBAs)
|
15.9 Minute
Standard Deviation 3.8
|
16.2 Minute
Standard Deviation 4.8
|
14.1 Minute
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Intraoperative, an average of 3 hours.Time from skin incision to wound dressing assessed up to 8 hours.
Outcome measures
| Measure |
Intubating Dose, Group I
n=27 Participants
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 Participants
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 Participants
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
|---|---|---|---|
|
Operation Time
|
151.8 Minute
Standard Deviation 27.2
|
147.0 Minute
Standard Deviation 31.4
|
145.9 Minute
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: Intraoperative, an average 4 hours.Time from induction to recovery of anesthesia, asessed up to 3 hours.
Outcome measures
| Measure |
Intubating Dose, Group I
n=27 Participants
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 Participants
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 Participants
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
|---|---|---|---|
|
Anesthetic Time
|
163.0 Minute
Standard Deviation 26.8
|
159.9 Minute
Standard Deviation 30.6
|
161.4 Minute
Standard Deviation 25.9
|
SECONDARY outcome
Timeframe: Intraoperative, an average of 3 hours.Additional Rescue Doses Per Hour Ratio is the number per hour of addition of rescue dose administrated with 10% of initial NMBAs dose. The formula is {(Addition number + 1 / Anesthetic time) x 60}.
Outcome measures
| Measure |
Intubating Dose, Group I
n=27 Participants
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 Participants
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 Participants
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
|---|---|---|---|
|
Additional Rescue Doses Per Hour Ratio.
|
1.43455 ratio
Standard Deviation 0.49108
|
1.21014 ratio
Standard Deviation 0.43501
|
0.82128 ratio
Standard Deviation 0.26596
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before and after induction of anesthesia, an average 10 min.Before induction of anesthesia, non invasive blood pressure was measured for baseline. And after injection of NMBAs, non invasive blood pressure was measured at 10 min.
Outcome measures
| Measure |
Intubating Dose, Group I
n=27 Participants
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 Participants
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 Participants
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
|---|---|---|---|
|
Non Invasive Blood Pressure,
Systolic pressure
|
128.3 mmHg
Standard Deviation 17.7
|
128.3 mmHg
Standard Deviation 20.7
|
128.4 mmHg
Standard Deviation 19.1
|
|
Non Invasive Blood Pressure,
Diastolic pressure
|
75.6 mmHg
Standard Deviation 9.7
|
76.7 mmHg
Standard Deviation 9.2
|
74.8 mmHg
Standard Deviation 9.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before and after induction of anesthesia, an average 10 min.Before induction of anesthesia, peripheral oxygen saturation was measured for baseline. And after injection of NMBAs, peripheral oxygen saturation was measured at 10 min.
Outcome measures
| Measure |
Intubating Dose, Group I
n=27 Participants
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 Participants
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 Participants
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
|---|---|---|---|
|
Peripheral Oxygen Saturation
|
100 Percentage
Standard Deviation 0.0
|
99.9 Percentage
Standard Deviation 0.2
|
100 Percentage
Standard Deviation 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before and after induction of anesthesia, an average 10 min.Before induction of anesthesia, body temperature was measured for baseline by oral temperature probe. And after injection of NMBAs, non invasive blood pressure was measured at 10 min by esophageal temperature probe.
Outcome measures
| Measure |
Intubating Dose, Group I
n=27 Participants
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 Participants
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 Participants
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
|---|---|---|---|
|
Body Temperature
|
36.3 Celcius degree
Standard Deviation 0.3
|
36.3 Celcius degree
Standard Deviation 0.2
|
36.3 Celcius degree
Standard Deviation 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before and after induction of anesthesia, an average 10 min.The BIS monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer. Before induction of anesthesia, bispectral index was measured for baseline. And after injection of NMBAs, bispectral index was measured at 10 min.
Outcome measures
| Measure |
Intubating Dose, Group I
n=27 Participants
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 Participants
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 Participants
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
|
|---|---|---|---|
|
Bispectral Index
|
46.0 BIS score
Standard Deviation 8.2
|
46.1 BIS score
Standard Deviation 7.5
|
44.3 BIS score
Standard Deviation 9.4
|
Adverse Events
Intubating Dose, Group I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intubating Dose, Group I
n=27 participants at risk
combined ED95 rocuronium and ED95 cisatracurium
ED95, dose causing on average 95% suppression of neuromuscular response.
The duration of intubation did not differ between groups. Group I and S were intubation Grade 0 (Excellent) intubation.
|
10% Reduction of Combination of Esmeron® and Nimbex®, Group S
n=27 participants at risk
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
The duration of intubation did not differ between groups. Group I and S were intubation Grade 0 (Excellent) intubation
|
20% Reduction of Combination of Esmeron® and Nimbex®, Group L
n=27 participants at risk
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
Group L included 1 patient with Grade 1 (Good) intubation and 2 patients with Grade 2 (Poor) intubation. The patients with Grade 2 intubation coughed during intubation and 1 of these patients produced small arm movements during coughing.
|
|---|---|---|---|
|
Investigations
Coughing
|
0.00%
0/27 • Adverse events are divided to intraoperative adverse events and postoperative adverse events. Intraoperative adverse events are collected until end of anesthesia. And postoperative adverse events are collected from end of anesthesia to 1 month (until next visiting outpatient clinic after discharge).
|
0.00%
0/27 • Adverse events are divided to intraoperative adverse events and postoperative adverse events. Intraoperative adverse events are collected until end of anesthesia. And postoperative adverse events are collected from end of anesthesia to 1 month (until next visiting outpatient clinic after discharge).
|
7.4%
2/27 • Number of events 2 • Adverse events are divided to intraoperative adverse events and postoperative adverse events. Intraoperative adverse events are collected until end of anesthesia. And postoperative adverse events are collected from end of anesthesia to 1 month (until next visiting outpatient clinic after discharge).
|
|
Investigations
Agitation
|
0.00%
0/27 • Adverse events are divided to intraoperative adverse events and postoperative adverse events. Intraoperative adverse events are collected until end of anesthesia. And postoperative adverse events are collected from end of anesthesia to 1 month (until next visiting outpatient clinic after discharge).
|
0.00%
0/27 • Adverse events are divided to intraoperative adverse events and postoperative adverse events. Intraoperative adverse events are collected until end of anesthesia. And postoperative adverse events are collected from end of anesthesia to 1 month (until next visiting outpatient clinic after discharge).
|
3.7%
1/27 • Number of events 1 • Adverse events are divided to intraoperative adverse events and postoperative adverse events. Intraoperative adverse events are collected until end of anesthesia. And postoperative adverse events are collected from end of anesthesia to 1 month (until next visiting outpatient clinic after discharge).
|
Additional Information
Dr. Wooyoung Park
Yonsei University Wonju college of medicine
Phone: 563664250
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place