Recovery After Sugammadex(Propofol vs Sevoflurane)

Anesthesia Clinical Trial

— Sugammadex2  

Official title:

Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579851
• Other study ID #: 2010/58
• Secondary ID: 2010-023943-13
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2012
• Last updated: May 19, 2017
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: May 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Sugammadex
sugammadex 4 mg/kg : if there is no response to Train of Four stimulations and at least one response to the Post Tetanic Count 2 mg/kg : if there is at least two responses to Train of Four stimulations

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with an increase in Bispectral Index after sugammadex injection	Increase in Bispectral Index (> 20) after sugammadex injection	One hour after anesthesia
Primary	Number of patients with occurence of clinical signs of awakening after sugammadex injection	Clinical signs of awakening after sugammadex are wallowing, eye opening on demand, cough, spontaneous movements, response to simple commands, tearing, ...	One hour after anesthesia
Secondary	T4/T1 ratio after sugammadex injection	Modification of T4/T1 ratio after sugammadex injection	One hour after anesthesia
Secondary	Number of patients with side effects due to sugammadex injection	Side effects after sugammadex injection are bradycardia, nausea or vomiting, pain, residual curarisation, awareness,...	One hour after anesthesia