Recovery After Sugammadex(Propofol vs Sevoflurane)

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Sugammadex

• Registration Number: NCT01579851
• Lead Sponsor: Hopital Foch

Brief Summary

Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. The goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-18
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• adult patients scheduled to receive general anesthesia with muscle relaxation achieved with rocuronium

Exclusion Criteria

• Known drug allergy,
• Contra-indications to the use of propofol, remifentanil, rocuronium, sevoflurane, sugammadex
• Difficulty to use Bispectral Index monitor
• Inability to obtain a proper monitoring of muscle relaxation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane-Remifentanil	Sugammadex	Anesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium
Propofol-Remifentanil	Sugammadex	Anesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium

Primary Outcome Measures

Name	Time	Method
Number of patients with an increase in Bispectral Index after sugammadex injection	One hour after anesthesia	Increase in Bispectral Index (\> 20) after sugammadex injection
Number of patients with occurence of clinical signs of awakening after sugammadex injection	One hour after anesthesia	Clinical signs of awakening after sugammadex are wallowing, eye opening on demand, cough, spontaneous movements, response to simple commands, tearing, ...

Secondary Outcome Measures

Name	Time	Method
T4/T1 ratio after sugammadex injection	One hour after anesthesia	Modification of T4/T1 ratio after sugammadex injection
Number of patients with side effects due to sugammadex injection	One hour after anesthesia	Side effects after sugammadex injection are bradycardia, nausea or vomiting, pain, residual curarisation, awareness,...

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, Ile de France, France