An interventional study of Injection of neostigmine or sugammadex in Neuromuscular Blockade, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-17.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
This study aims to make a comparison of surgical condition and recovery time between rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.
This study aims to make a comparison of surgical condition and recovery time between moderate neuromuscular bloackade with reversal using neostigmine group and deep neuromuscular bloackade with reversal using sugammadex group.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Injection of neostigmine or 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.
Other: 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.
Also known as: neostigmin or sugammadex
Laryngoscopic Score
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
Time frame: At the beginning of surgery, the surgeon rated the laryngoscopy condition
Recovery Time From Neuromuscular Blockade
We measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9
Time frame: from the injection of neostigmine or sugammadex up to 30 minutes
| Milestone | Rocuronium 0.45 - Neostigmine | Rocuronium 0.9 - Sugammadex |
|---|---|---|
| Started | 22 | 22 |
| Completed | 19 | 21 |
| Not completed | 3 | 1 |
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
| Participants | Rocuronium 0.45 - Neostigmine | Rocuronium 0.9 - Sugammadex |
|---|---|---|
| Difficult | 1 | 0 |
| Fair | 11 | 0 |
| Easy | 9 | 19 |
We measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9
| minute | Rocuronium 0.45 - Neostigmine | Rocuronium 0.9 - Sugammadex |
|---|---|---|
| Recovery Time From Neuromuscular Blockade | 9.9 ± 4.0 | 2.1 ± 0.6 |
Collected over postoperative one month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rocuronium 0.45 - Neostigmine | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Rocuronium 0.9 - Sugammadex | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Categorical(Participants) | Rocuronium 0.45 - Neostigmine | Rocuronium 0.9 - Sugammadex | Total |
|---|---|---|---|
| Population from 18 years to 65 years — <=18 years | 0 | 0 | 0 |
| Population from 18 years to 65 years — Between 18 and 65 years | 22 | 22 | 44 |
| Population from 18 years to 65 years — >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Rocuronium 0.45 - Neostigmine | Rocuronium 0.9 - Sugammadex | Total |
|---|---|---|---|
| Female | 6 | 10 | 16 |
| Male | 16 | 12 | 28 |
| Race/Ethnicity, Customized(Participants) | Rocuronium 0.45 - Neostigmine | Rocuronium 0.9 - Sugammadex | Total |
|---|---|---|---|
| Number of South Korean participants | 22 | 22 | 44 |
| Region of Enrollment(participants) | Rocuronium 0.45 - Neostigmine | Rocuronium 0.9 - Sugammadex | Total |
|---|---|---|---|
| Korea, Republic of | 22 | 22 | 44 |
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital