The Effect of Sugammadex Given Based on Ideal, Actual or Adjusted Body Weight on Reversal of Rocuronium.

Not Applicable

Completed

• Conditions: Muscle Relaxation
• Interventions: Drug: Sugammadex

• Registration Number: NCT03381209
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight.

Detailed Description

The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight. Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.

Time need for extubation (time from administration of sugammadex to extubation), and duration of stay in post anesthesia care unit (PACU), will be used as secondary outcome.

Study Timeline

• Study Start: 2017-06-10
• Primary Completion: 2017-11-10
• Study Completion: 2017-11-10
• Status Verified: 2017-12
• Study First Submitted: 2017-12-17
• Study First Submitted QC: 2017-12-20
• Last Update Submitted: 2017-12-20
• Study First Posted: 2017-12-21
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients older than 18 years and under 45 years,
• body mass index ≥ 40 kg/m2, with indication of bariatric surgery

Exclusion Criteria

• Patients with comorbid including: neuromuscular disease, renal impairment, and patients with difficult airway were excluded from this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Sugammadex	Sugammadex given in a dose of 2mg/kg based on ideal body weight
Group B	Sugammadex	Sugammadex given in a dose of 2mg/kg based on adjusted body weight
Group C	Sugammadex	Sugammadex given in a dose of 2mg/kg based on actual body weight

Primary Outcome Measures

Name	Time	Method
Reversal Time	5 minutes after sugammadex administration	Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.

Secondary Outcome Measures

Name	Time	Method
duration of stay in PACU	60 minutes after admission to the PACU	period of stay in the PACU
Time need for Extubation	10 minutes after sugammadex administration	time from administration of sugammadex to extubation

Trial Locations

Locations (1)

Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt