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OpenTrials
Completed

NCT Number: NCT02375217

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

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.

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Key information

Conditions

Anesthesia Recovery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AUBMC

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

half dose

Neostigmine

Drug

IV = 50mcg/kg

Glycopyrrolate

Drug

Primary outcomes

  1. TOF ratio of 0.9

    Time frame: within 5 minutes

Secondary outcomes

  1. the time to return of TOF ratio to 0.9 and the time till extubation

    Time frame: within 10 minutes

  2. Residual neuro-muscular blockade

    Time frame: within 10 to 180 mins

    Post Anesthesia recovery unit

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 2, 2015
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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