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

Last updated: January 25, 2025
Sponsor: Universitas Padjadjaran
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Sugammadex 1 mg/kg

Neostigmine + Atropine

Clinical Study ID

NCT06794450
AN-202412.01
  • Ages 18-59
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • 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.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Sugammadex 1 mg/kg
Phase: 1/2
Study Start date:
November 05, 2024
Estimated Completion Date:
February 28, 2025

Study Description

Neuromuscular blocking agents are frequently utilized to facilitate tracheal intubation, minimize the risk of vocal cord injury, suppress patient movement, and ensure optimal ventilation. The administration of these agents, along with meticulous monitoring of neuromuscular blockade depth, plays a critical role in optimizing the success rates and minimizing complications associated with various surgical procedures, including laparotomy and laparoscopic abdominal surgeries.

At the conclusion of surgery, when muscle relaxation is no longer required, neuromuscular blockade should be reversed promptly, safely, and reliably using appropriate reversal agents to minimize the risk of postoperative complications associated with residual neuromuscular blockade. A study reported that 64% of patients undergoing general anesthesia exhibited a neuromuscular recovery of less than 90% and experienced symptoms of re-curarization in the recovery room.

Various reversal agents are available to counteract the effects of neuromuscular blockade, utilizing either direct or indirect mechanisms of action. Cholinesterase inhibitors, such as neostigmine, are among the most commonly used agents. They act indirectly by inhibiting acetylcholinesterase, thereby preventing the breakdown of acetylcholine at the neuromuscular junction. However, this mechanism is reliant on the individual's acetylcholine production rate, which can limit neostigmine's effectiveness, contributing to its unpredictability, and increase the risk of re-curarization. In contrast, sugammadex is a specialized reversal agent designed specifically to counteract neuromuscular blockade induced by rocuronium. Unlike neostigmine, sugammadex employs a direct mechanism by encapsulating rocuronium molecules and forming an inactive complex. This approach enables a faster onset of action and provides a more consistent and predictable recovery profile.

The utilization of sugammadex in Indonesia remains relatively limited, despite the frequent use of rocuronium as a muscle relaxant. This limited use is largely attributed to the significantly higher cost of sugammadex compared to neostigmine. Nonetheless, research has demonstrated that even at doses lower than the recommended levels, sugammadex achieves faster recovery times compared to neostigmine in reversing neuromuscular blockade induced by rocuronium. This trial looks forward to answering the recovery time of half-dose recommended sugammadex compared with neostigmine with usual dose.

Connect with a study center

  • Hasan Sadikin General Hospital

    Bandung, Jawa Barat 40161
    Indonesia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.