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

Muscle Relaxation Clinical Trial

Official title:

The Effect of Sugammadex Given Based on Ideal, Actual or Adjusted Body Weights on Reversal of Neuromuscular Blockade in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381209
• Other study ID #: FMASU R 39/2017
• Status: Completed
• Phase: N/A
• First received: December 17, 2017
• Last updated: December 20, 2017
• Start date: June 10, 2017
• Est. completion date: November 10, 2017

Study information

• Verified date: December 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 10, 2017
• Est. primary completion date: November 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Muscle Relaxation

Intervention

Drug:
• Sugammadex
sugammadex given based on 3 measurements of body weights

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversal Time	Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio = 0.9 will be used as primary outcome.	5 minutes after sugammadex administration
Secondary	duration of stay in PACU	period of stay in the PACU	60 minutes after admission to the PACU
Secondary	Time need for Extubation	time from administration of sugammadex to extubation	10 minutes after sugammadex administration