Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 59Years
All Genders
ID06794450

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

Led by Universitas Padjadjaran · Updated on 2025-01-28

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Neuromuscular blocking agents like rocuronium are often used during surgeries such as laparoscopic cholecystectomy to help with intubation and muscle relaxation. This research compares two drugs, sugammadex and neostigmine, used to reverse the muscle relaxation after surgery. The goal is to see if half-dose sugammadex leads to faster recovery times than neostigmine, which is commonly used but has a slower and less predictable recovery. Participants will receive either sugammadex at 1 mg/kg or neostigmine at 60 mcg/kg combined with atropine after their surgery when moderate neuromuscular blockade is detected. Both groups will undergo the same anesthetic protocol, and muscle recovery will be monitored with a device called an acceleromyography monitor. Extubation will occur once the muscle function reaches a specific recovery level. During the study, patients' muscle recovery times and possible side effects like bradycardia and hypotension will be closely observed. Monitoring includes checking the Train of Four Ratio to ensure safe extubation. The main outcome measured is the recovery time within one hour after reversal drug administration, with additional assessments for spontaneous recovery and safety within a few hours after surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 59Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who underwent laparoscopic cholecystectomy under general anesthesia
  • Using muscle relaxant rocuronium
  • Aged 18-59 years
  • American Society of Anesthesiologists (ASA) physical status classification of 1 or 2
Not Eligible

You will not qualify if you...

  • History of drug allergies to the agents used
  • Renal dysfunction
  • Musculoskeletal disorders
  • Central nervous system disorders
  • Difficult airways requiring intubation without the use of muscle relaxants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day with immediate recovery period

Participants undergo laparoscopic cholecystectomy surgery with general anesthesia and muscle relaxant rocuronium. At the end of surgery, participants receive either sugammadex 1 mg/kg or neostigmine 60 mcg/kg with atropine to reverse neuromuscular blockade. Extubation occurs when neuromuscular recovery is sufficient.

1 surgical procedure visit and immediate post-operative monitoring

Follow-up

Duration - Up to 3 hours post-treatment

Participants are monitored for recovery times and potential side effects such as bradycardia and hypotension after receiving the reversal agents.

Monitoring during the recovery period after surgery

Trial Site Locations

Total: 1 location

1

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia, 40161

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Research Team

R

Rivan P Rivan Putra Afewa, M.D., M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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