Trial Outcomes & Findings for Sugammadex Provide Better Surgical Condition Compared With Neostigmine in Laryngeal Microsurgery. (NCT NCT02330172)
NCT ID: NCT02330172
Last Updated: 2017-04-17
Results Overview
Definitions for evaluation of Laryngoscopycondition. : Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy. Variables Excellent Good Poor
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
At the beginning of surgery, the surgeon rated the laryngoscopy condition
Results posted on
2017-04-17
Participant Flow
Participant milestones
| Measure |
Rocuronium 0.45 - Neostigmine
when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.
When the end of operation, a injection of neostigmine or sugammadex will be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
|
Rocuronium 0.9 - Sugammadex
When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.
When the end of operation,, a injection of neostigmine or sugammadex be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sugammadex Provide Better Surgical Condition Compared With Neostigmine in Laryngeal Microsurgery.
Baseline characteristics by cohort
| Measure |
Rocuronium 0.45 - Neostigmine
n=22 Participants
when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.
When the end of operation, a injection of neostigmine or sugammadex will be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
|
Rocuronium 0.9 - Sugammadex
n=22 Participants
When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.
When the end of operation,, a injection of neostigmine or sugammadex be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Population from 18 years to 65 years · <=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Population from 18 years to 65 years · Between 18 and 65 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
Population from 18 years to 65 years · >=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Number of South Korean participants
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the beginning of surgery, the surgeon rated the laryngoscopy conditionPopulation: Definitions for evaluation of Laryngoscopycondition. : Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy. Variables Excellent Good Poor
Definitions for evaluation of Laryngoscopycondition. : Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy. Variables Excellent Good Poor
Outcome measures
| Measure |
Rocuronium 0.45 - Neostigmine
n=21 Participants
when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.
When the end of operation, a injection of neostigmine or sugammadex will be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
|
Rocuronium 0.9 - Sugammadex
n=19 Participants
When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.
When the end of operation,, a injection of neostigmine or sugammadex be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
|
|---|---|---|
|
Laryngoscopic Score
Easy
|
9 Participants
|
19 Participants
|
|
Laryngoscopic Score
Difficult
|
1 Participants
|
0 Participants
|
|
Laryngoscopic Score
Fair
|
11 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from the injection of neostigmine or sugammadex up to 30 minutesWe measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9
Outcome measures
| Measure |
Rocuronium 0.45 - Neostigmine
n=21 Participants
when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.
When the end of operation, a injection of neostigmine or sugammadex will be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
|
Rocuronium 0.9 - Sugammadex
n=19 Participants
When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.
When the end of operation,, a injection of neostigmine or sugammadex be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
|
|---|---|---|
|
Recovery Time From Neuromuscular Blockade
|
9.9 minute
Standard Deviation 4.0
|
2.1 minute
Standard Deviation 0.6
|
Adverse Events
Rocuronium 0.45 - Neostigmine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rocuronium 0.9 - Sugammadex
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