Recovery After Sugammadex(Propofol vs Sevoflurane)
Sugammadex2
Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)
2 other identifiers
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 4, 2012
CompletedFirst Posted
Study publicly available on registry
April 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMay 22, 2017
May 1, 2017
3 years
January 4, 2012
May 19, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patients with an increase in Bispectral Index after sugammadex injection
Increase in Bispectral Index (\> 20) after sugammadex injection
One hour after anesthesia
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 Outcomes (2)
T4/T1 ratio after sugammadex injection
One hour after anesthesia
Number of patients with side effects due to sugammadex injection
One hour after anesthesia
Study Arms (2)
Propofol-Remifentanil
ACTIVE COMPARATORAnesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium
Sevoflurane-Remifentanil
ACTIVE COMPARATORAnesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium
Interventions
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
Eligibility Criteria
You may qualify if:
- adult patients scheduled to receive general anesthesia with muscle relaxation achieved with rocuronium
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (1)
Hopital Foch
Suresnes, Île-de-France Region, 92151, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Morgan Le Guen, MD
Hopital Foch
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2012
First Posted
April 18, 2012
Study Start
January 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
May 22, 2017
Record last verified: 2017-05