RecruitingPhase 1Phase 2NCT06794450

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

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


Sponsor

Universitas Padjadjaran

Enrollment

60 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 59 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria5

  • 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.

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Interventions

DRUGSugammadex 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

DRUGNeostigmine + 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

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NCT06794450


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