"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"

Phase 4

Completed

• Conditions: Anesthesia Recovery
• Interventions: Drug: Sugammadex; Drug: Neostigmine; Drug: glycopyrrolate

• Registration Number: NCT02375217
• Lead Sponsor: American University of Beirut Medical Center

Brief Summary

Prospective Randomized non inferiority Trial involving adult patients undergoing elective surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose sugammadex vs half dose sugammadex for reversal of NMB.

Detailed Description

The investigators' aim is to prove that half dose sugammadex in combination with neostigmine 0.05 mg/kg is non-inferior to the recommended dose of sugammadex for the reversal of deep ( absence of Trian of Four response :TOF) or moderate ( TOF 1 or 2 twiches) muscle paralysis in patients undergoing surgery under general anesthesia.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-02-11
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patients aged 18-70
• ASA class I, II, and III
• undergoing surgery under balanced general anesthesia requiring the use of muscle relaxants throughout the surgery

Exclusion Criteria

• patients undergoing emergency surgeries
• pregnant patients
• patients with end stage renal disease or chronic kidney disease(GFR less than 60)
• patients with allergy to sugammadex or who had previous complications or side effects from previous sugammadex administration
• patients' refusal
• patients with allergy to recuronium

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 : (NS)	Sugammadex	Group 1 Drug combination: patients receive half of the recommended dose of sugammadex plus dose of neostigmine" 1. Sugammadex IV= -1 mg/kg( moderate NMB) or * 2 mg/kg (deep NMB) 2. neostigmine IV = 50mcg/kg 3. glycopyrrolate 10 mcg/kg
Group 2 : (S)	Sugammadex	patients receive Full recommended dose of sugammadex Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB)
Group 1 : (NS)	Neostigmine	Group 1 Drug combination: patients receive half of the recommended dose of sugammadex plus dose of neostigmine" 1. Sugammadex IV= -1 mg/kg( moderate NMB) or * 2 mg/kg (deep NMB) 2. neostigmine IV = 50mcg/kg 3. glycopyrrolate 10 mcg/kg
Group 1 : (NS)	glycopyrrolate	Group 1 Drug combination: patients receive half of the recommended dose of sugammadex plus dose of neostigmine" 1. Sugammadex IV= -1 mg/kg( moderate NMB) or * 2 mg/kg (deep NMB) 2. neostigmine IV = 50mcg/kg 3. glycopyrrolate 10 mcg/kg

Primary Outcome Measures

Name	Time	Method
TOF ratio of 0.9	within 5 minutes

Secondary Outcome Measures

Name	Time	Method
the time to return of TOF ratio to 0.9 and the time till extubation	within 10 minutes
Residual neuro-muscular blockade	within 10 to 180 mins	Post Anesthesia recovery unit

Trial Locations

Locations (1)

AUBMC; 🇱🇧 Beirut, Lebanon