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

NCT02375217 | Completed Phase 4

• 1 other identifier: ANES.MA.14
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Recovery

Outcome Measures

Primary Outcomes (1)

• TOF ratio of 0.9

  within 5 minutes

Secondary Outcomes (2)

• 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

Study Arms (2)

Group 1 : (NS)

ACTIVE COMPARATOR

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

Drug: Sugammadex; Drug: Neostigmine; Drug: glycopyrrolate

Group 2 : (S)

ACTIVE COMPARATOR

patients receive Full recommended dose of sugammadex Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB)

Drug: Sugammadex

Interventions

Sugammadex DRUG

half dose

Group 1 : (NS)

Neostigmine DRUG

IV = 50mcg/kg

Group 1 : (NS)

glycopyrrolate DRUG

Group 1 : (NS)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

AUBMC

Beirut, Lebanon

Location

Related Publications (1)

• Aouad MT, Alfahel WS, Kaddoum RN, Siddik-Sayyid SM. Half dose sugammadex combined with neostigmine is non-inferior to full dose sugammadex for reversal of rocuronium-induced deep neuromuscular blockade: a cost-saving strategy. BMC Anesthesiol. 2017 Apr 11;17(1):57. doi: 10.1186/s12871-017-0348-9.

  PMID: 28399799 DERIVED

MeSH Terms

Interventions

Sugammadex; Neostigmine; Glycopyrrolate

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; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marie Mn Aouad,, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of clinical Specialty

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: March 2, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

LE (1)