Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT03515694
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2018-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimal Optimal Dose of Sugammadex in Elective Surgery
Sponsor:
Erasme University Hospital
Organization:
Study Overview
Official Title:
Minimal Optimal Dose of Sugammadex in Elective Surgery
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Time of appearance of TOF Ratio \>0,9 with different doses of Sugammadex
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: