Minimal Optimal Dose of Sugammadex in Elective Surgery

Time of a TOF Ratio >0,9 Clinical Trial

Official title:

Minimal Optimal Dose of Sugammadex in Elective Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515694
• Other study ID #: BRIDION_ERASME
• Status: Completed
• Phase: Phase 4
• Start date: April 3, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2018
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Time of a TOF Ratio >0,9

Intervention

Drug:
• Sugammadex Injection [Bridion]
Injection of 10mL of translucide solution

Locations

Country	Name	City	State
Belgium	Hopital Erasme	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the recovery time of the ratio 0.9.	Evaluate the recovery time of the ratio 0.9.	1 hour
Secondary	Time of appearance of 4 responses to the TOF	Time of appearance of 4 responses to the TOF	1 hour
Secondary	Evaluate the four-to-four ratio <0.7 after total recovery.	Evaluate the four-to-four ratio <0.7 after total recovery.	1 hour
Secondary	Watch time at the recovery room.	Watch time at the recovery room.	4 hours