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OpenTrials
Completed

NCT Number: NCT03515694

Minimal Optimal Dose of Sugammadex in Elective Surgery

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Erasme

Brussels, 1070, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugammadex Injection [Bridion]

Drug

Injection of 10mL of translucide solution

Primary outcomes

  1. Evaluate the recovery time of the ratio 0.9.

    Time frame: 1 hour

    Evaluate the recovery time of the ratio 0.9.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 3, 2018
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.