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RECRUITING
NCT06794450
PHASE1/PHASE2

Recovery Times of Half Dose Sugammadex and Neostigmine for Rocuronium-induced Neuromuscular Blockade

Sponsor: Universitas Padjadjaran

View on ClinicalTrials.gov

Summary

In operating procedure with general anesthesia muscle relaxant is usually used to increase success rate of the operation and to give better outcome. The use of reversal drugs aims to reduce the risk of post-operative complications due to muscle relaxants. Neostigmine is commonly used as a reversal drug, but its indirect mechanism of action results in a long and unpredictable recovery time. Sugammadex directly bind and inactivate rocuronium, in which resulting in a faster and predictable recovery time. However, the high price limits the use of sugammadex. This study aims to compare the effect of half dose sugammadex and neostigmine against the moderate neuromuscular blockade of rocuronium. The main questions it aims to answer are: Does half dose sugammadex gives faster recovery time? Researchers will compare sugammadex to neostigmine to see if sugammadex gives faster recovery time. Participants will: Be given sugammadex or neostigmine as a reversal drug after the operation done

Official title: Comparison of Recovery Times Between 1 mg/kg Sugammadex and 60 mcg/kg Neostigmine for Moderate Neuromuscular Blockade Induced by Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-11-05

Completion Date

2025-02

Last Updated

2025-01-28

Healthy Volunteers

No

Interventions

DRUG

Sugammadex 1 mg/kg

Patient in experimental arms will receive i.v. sugammadex 1 mg/kg at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed

DRUG

Neostigmine + Atropine

Patient in active comparators arms will receive i.v. neostigmine 60 mcg/kg along with 0.4 mg of atropine sulfate per 1 mg of neostigmine at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed

Locations (1)

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia