Sugammadex2: Recovery After Sugammadex(Propofol vs Sevoflurane)

• Sponsor: Hopital Foch (Other)
• Overall Status: Completed
• CT.gov ID: NCT01579851
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Sugammadex	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Propofol-Remifentanil Anesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium	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
Active Comparator: Sevoflurane-Remifentanil Anesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium	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

Outcome Measures

Primary Outcome Measures

1. Number of patients with an increase in Bispectral Index after sugammadex injection [One hour after anesthesia]

   Increase in Bispectral Index (> 20) after sugammadex injection

2. 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

1. T4/T1 ratio after sugammadex injection [One hour after anesthesia]

   Modification of T4/T1 ratio after sugammadex injection

2. 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,...

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Foch	Suresnes	Ile de France	France	92151

Sponsors and Collaborators

• Hopital Foch

Investigators

• Principal Investigator: Morgan Le Guen, MD, Hopital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT01579851
• Other Study ID Numbers: 2010/58; 2010-023943-13
• First Posted: Apr 18, 2012
• Last Update Posted: May 22, 2017
• Last Verified: May 1, 2017

Study Results

No Results Posted as of May 22, 2017