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Minimal Optimal Dose of Sugammadex in Elective Surgery

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ClinicalTrials.gov Identifier: NCT03515694
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital

Brief Summary:
Time of appearance of TOF Ratio >0,9 with different doses of Sugammadex

Condition or disease Intervention/treatment Phase
Time of a TOF Ratio >0,9 Drug: Sugammadex Injection [Bridion] Phase 4

Detailed Description:

Design: monocentric, prospective, controlled, randomized, double-blind study Inclusion criteria: women and men> 18 years old, elective surgery, BMI <30, patients giving consent to free and informed participation in writing;

Exclusion criteria:

  • minor patients;
  • Patients refusing to sign the consent;
  • Patients included in another protocol within 3 months;
  • Pregnant or lactating patients;
  • Patients with a history of allergy to Sugammadex;
  • Patients with known neuromuscular disease;
  • Patients with renal or hepatic impairment.

Course of the study :

  • 40 patients will be recruited at the time of the anesthesia consultation and randomized to double blind in 8 groups (the day before surgery)
  • All patients will benefit from general anesthesia. Anesthetic management

    (1- 3mg / kg / IV propofol, 0.2 μg / IV sufentanil, 0.6 mg / kg rocuronium and maintenance anesthesia with sevoflurane) will be standardized for all patients.

  • Upon administration of rocuronium the acceleromyography transducer will be attached to the distal phalanx of the thumb, and repeated TOF stimulation will be applied to the ulnar nerve wrist at intervals of 15 seconds. Neuromuscular monitoring is continued until the end of the anesthesia.
  • Once the first answer (1st twitch) appeared a dose of sugammadex will be administered according to the group whose patient was randomized: Test Groups Control Groups Group 1: Placebo + TOF 1 Group 1bis: Placebo + TOF2 Group 2: 0.5 mg / kg + TOF1 Group 2bis: 0.5 mg / kg + TOF2 Group 3: 1mg / kg + TOF1 Group 3bis: 1mg / kg + TOF2 Group 4: 2mg / kg + TOF 1 Group 4bis: 2mg / kg + TOF 2
  • Then a standard dose of 4mg / kg will be administered at the end of the procedure before awakening to all patients who have signs of residual curarization (TOF ratio <0.9). The pharmacy will be responsible for preparing the different doses of sugammadex, the syringe will be carefully covered and packaged, will contain an equal volume so that the anesthetists do not know which group the patient belongs to. Data collection: In real time during the intervention by the anesthesiologist in charge of patient Method of Analysis: Analysis of intent-to-treat data

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel, Double blind Monocentric Prospective Vs placebo
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Minimal Optimal Dose of Sugammadex in Elective Surgery
Actual Study Start Date : April 3, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Dose of 0mg/kg TOF1 Drug: Sugammadex Injection [Bridion]
Injection of 10mL of translucide solution

Placebo Comparator: Dose of 0mg/kg TOF2 Drug: Sugammadex Injection [Bridion]
Injection of 10mL of translucide solution

Experimental: Dose of 0 ,5mg/kg TOF1 Drug: Sugammadex Injection [Bridion]
Injection of 10mL of translucide solution

Active Comparator: Dose of 0,5mg/kg TOF2 Drug: Sugammadex Injection [Bridion]
Injection of 10mL of translucide solution

Experimental: Dose of 1mg/kg TOF1 Drug: Sugammadex Injection [Bridion]
Injection of 10mL of translucide solution

Active Comparator: Dose of 1mg/kg TOF2 Drug: Sugammadex Injection [Bridion]
Injection of 10mL of translucide solution

Experimental: Dose of 2mg/kg TOF1 Drug: Sugammadex Injection [Bridion]
Injection of 10mL of translucide solution

Active Comparator: Dose of 2mg/kg TOF2 Drug: Sugammadex Injection [Bridion]
Injection of 10mL of translucide solution




Primary Outcome Measures :
  1. Evaluate the recovery time of the ratio 0.9. [ Time Frame: 1 hour ]
    Evaluate the recovery time of the ratio 0.9.


Secondary Outcome Measures :
  1. Time of appearance of 4 responses to the TOF [ Time Frame: 1 hour ]
    Time of appearance of 4 responses to the TOF

  2. Evaluate the four-to-four ratio <0.7 after total recovery. [ Time Frame: 1 hour ]
    Evaluate the four-to-four ratio <0.7 after total recovery.

  3. Watch time at the recovery room. [ Time Frame: 4 hours ]
    Watch time at the recovery room.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

women and men> 18 years of age Elective Surgery BMI <30, patients who gave consent to free and informed participation in writing

Exclusion Criteria:

  • minor patients;
  • patients refusing to sign consent;
  • patients included in another protocol within 3 months;
  • pregnant or nursing patients;
  • patients with a history of allergy to Sugammadex;
  • patients with known neuromuscular disease
  • patients with renal or hepatic impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515694


Locations
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Belgium
Hopital Erasme
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
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Principal Investigator: Wendy FERNANDEZ, Resident Erasme University Hospital

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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03515694     History of Changes
Other Study ID Numbers: BRIDION_ERASME
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Erasme University Hospital:
Bridion
Sugammadex
TOF