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

Anesthesia Recovery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375217
• Other study ID #: ANES.MA.14
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: June 2018
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Recovery

Intervention

Drug:
• Sugammadex
half dose
• Sugammadex
full dose
• Neostigmine
IV = 50mcg/kg
• glycopyrrolate

Locations

Country	Name	City	State
Lebanon	AUBMC	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOF ratio of 0.9		within 5 minutes
Secondary	the time to return of TOF ratio to 0.9 and the time till extubation		within 10 minutes
Secondary	Residual neuro-muscular blockade	Post Anesthesia recovery unit	within 10 to 180 mins