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

NCT06794450 | Recruiting Phase 1 DMC

• 1 other identifier: AN-202412.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Neuromuscular Blocking Agents; Reversal of Neuromuscular Blockade; Recovery Time

Keywords

Sugammadex; Neostigmine; recovery time from neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• Recovery time

  This refers to the duration measured from the point at which a Train-of-Four Count (TOFC) of 2 is observed, indicating the administration of the reversal agent, to the achievement of a Train-of-Four Ratio (TOFR) of 90%. Train of four is a electrical stimulus pattern that describe the neuromuscular blockade depth. Acceleromyography device used to monitor the neuromuscular blockade depth. Train of Four count (TOFC) 1-3 counted as moderate neuromuscular blockade, train of count (TOFC) 0 counted as deep neuromuscular blockade, train of four count (TOFC) 4 until train of four ratio (TOFR) 89% counted as mild or minimal neuromuscular blockade, and train of four ratio (TOFR) 90% counted as adequate recovery

  1 hour

Secondary Outcomes (3)

• Spontaneous recovery time of rocuronium

  3 hours

• Bradycardia

  1 hour

• Hypotension

  1 hour

Study Arms (2)

Sugammadex

EXPERIMENTAL

The subjects in this study were patients underwent laparoscopic cholecystectomy surgery with general anesthesia and muscle relaxant Rocuronium. At the end of the surgery, thirty patients will be administered Sugammadex 1 mg/kg as a reversal agent. All patient will receive same anesthetic drug. Patients will be monitored with acceleromyography monitoring tools. Extubation was performed when the Train of Four monitor reached a Train of Four Ratio ≥ 90%.

Drug: Sugammadex 1 mg/kg

Neostigmine

ACTIVE COMPARATOR

The subjects in this study were patients underwent laparoscopic cholecystectomy surgery with general anesthesia and muscle relaxant rocuronium. At the end of the surgery, thirty patients will be administered Neostigmine 60 mcg/kg along with 0.4 mg of atropine sulfate per 1 mg of neostigmine as a reversal agent. All patient will receive same anesthetic drug. Patients will be monitored with acceleromyography monitoring tools. Extubation was performed when the Train of Four monitor reached a Train of Four Ratio ≥ 90%.

Drug: Neostigmine + Atropine

Interventions

Sugammadex 1 mg/kg DRUG

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

Sugammadex

Neostigmine + Atropine DRUG

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

Neostigmine

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

RECRUITING

MeSH Terms

Interventions

Sugammadex; Neostigmine; Atropine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Tini T Maskoen, M.D.

  Faculty of Medicine Universitas Padjadjaran

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+6285316832464; rivan.chaniago@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 27, 2025
• Study Start: November 5, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

ID (1)