CompletedNCT01579851Sugammadex2Updated May 22, 2017

Recovery After Sugammadex(Propofol vs Sevoflurane)

A Phase 4 interventional study of Sugammadex in Anesthesia, sponsored by Hopital Foch. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-22.

Sponsored by Hopital Foch · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 71
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Anesthesia

In context

Lead sponsor

Hopital Foch is the lead sponsor of 215 studies on the registry; 21 are open to participants now.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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Inclusion criteria

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

Exclusion criteria

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

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 71 participants (actual)

Study arms

Active comparator
Propofol-Remifentanil
Anesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium
Drug: Sugammadex
Active comparator
Sevoflurane-Remifentanil
Anesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium
Drug: Sugammadex

Interventions

DrugSugammadex
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

What researchers measure

Primary outcomes

Number of patients with an increase in Bispectral Index after sugammadex injection
Increase in Bispectral Index (\> 20) after sugammadex injection
Time frame: 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, ...
Time frame: One hour after anesthesia

Secondary outcomes

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

Study locations

1 site

Hopital Foch
Suresnes, Île-de-France Region 92151, France

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of Jan 2015 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 4, 2012
First posted: Apr 18, 2012
Start: Jan 2012
Primary completionActual: Jan 2015
CompletionActual: Jan 2015
Last update: May 22, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01579851
Lead sponsor: Hopital Foch
Responsible party: Sponsor
First posted: Apr 18, 2012
Start date: Jan 2012
Primary completion: Jan 2015
Completion: Jan 2015
Last update: May 22, 2017

Study contacts

Morgan Le Guen, MD

principal investigator · Hopital Foch

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Sugammadex

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