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

June 26, 2018 updated by: Dr. Marie Awad, American University of Beirut Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 : (NS)

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
half dose
Drug: Sugammadex
full dose
Drug: Neostigmine
IV = 50mcg/kg
Drug: glycopyrrolate
Active Comparator: Group 2 : (S)

patients receive Full recommended dose of sugammadex

Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB)
Drug: Sugammadex
half dose
Drug: Sugammadex
full dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TOF ratio of 0.9
Time Frame: within 5 minutes
within 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the time to return of TOF ratio to 0.9 and the time till extubation
Time Frame: within 10 minutes
within 10 minutes
Residual neuro-muscular blockade
Time Frame: within 10 to 180 mins
Post Anesthesia recovery unit
within 10 to 180 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Investigators

  • Principal Investigator: Marie Mn Aouad,, MD, American University of Beirut Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANES.MA.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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