Minimal Optimal Dose of Sugammadex in Elective Surgery
1 other identifier
interventional
40
1 country
1
Brief Summary
Time of appearance of TOF Ratio \>0,9 with different doses of Sugammadex
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2018
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2018
CompletedFirst Submitted
Initial submission to the registry
April 23, 2018
CompletedFirst Posted
Study publicly available on registry
May 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedFebruary 15, 2019
April 1, 2018
6 months
April 23, 2018
February 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the recovery time of the ratio 0.9.
Evaluate the recovery time of the ratio 0.9.
1 hour
Secondary Outcomes (3)
Time of appearance of 4 responses to the TOF
1 hour
Evaluate the four-to-four ratio <0.7 after total recovery.
1 hour
Watch time at the recovery room.
4 hours
Study Arms (8)
Dose of 0mg/kg TOF1
PLACEBO COMPARATORDose of 0mg/kg TOF2
PLACEBO COMPARATORDose of 0 ,5mg/kg TOF1
EXPERIMENTALDose of 0,5mg/kg TOF2
ACTIVE COMPARATORDose of 1mg/kg TOF1
EXPERIMENTALDose of 1mg/kg TOF2
ACTIVE COMPARATORDose of 2mg/kg TOF1
EXPERIMENTALDose of 2mg/kg TOF2
ACTIVE COMPARATORInterventions
Injection of 10mL of translucide solution
Eligibility Criteria
You may qualify if:
- women and men\> 18 years of age Elective Surgery BMI \<30, patients who gave consent to free and informed participation in writing
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Erasme
Brussels, 1070, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy FERNANDEZ, Resident
Erasme University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2018
First Posted
May 3, 2018
Study Start
April 3, 2018
Primary Completion
September 30, 2018
Study Completion
September 30, 2018
Last Updated
February 15, 2019
Record last verified: 2018-04