Actively Recruiting
Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery: Single-center Prospective Randomized Double-blind Non-inferiority Study
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-06-06
594
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of two anesthesia drugs, dexmedetomidine and sufentanil, during scheduled outpatient surgeries. The study aims to compare the impact of these drugs on hemodynamic stability, meaning how stable blood pressure and heart rate remain during the induction of general anesthesia. This study focuses on patients undergoing various types of surgeries such as oral, orthopedic, urological, digestive, and gynecological procedures, and addresses concerns related to opiates causing nausea, vomiting, and delayed awakening. Participants will be randomly assigned to receive either dexmedetomidine or sufentanil during the induction of general anesthesia. Dexmedetomidine will be given as a titrated intravenous bolus dose of 0.5 µg/kg up to a maximum of 50 µg over 5 minutes. Sufentanil will be administered intravenously at a dose of 0.25 µg/kg, with a maximum of 20 µg, at anesthetic induction. The study is double-blinded, meaning neither the patients nor the researchers know which treatment is given. The focus is on outpatient surgeries where managing pain and side effects efficiently is important. During the study, participants will be closely monitored for intraoperative hemodynamic stability within 60 minutes after anesthesia induction. Additional assessments include heart rate, blood pressure episodes, vasopressor and atropine use during surgery, and recovery in the intensive care unit on the day of surgery. Patient-reported pain and nausea will be tracked up to seven days after surgery. Researchers will also evaluate the overall success of ambulatory management, patient satisfaction, and any adverse events following surgery. The total duration of participation spans from the day of surgery to seven days post-operation.
CONDITIONS
Brief Title
Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient scheduled for oral, orthopedic, urological, digestive, or gynecological surgery under general anesthesia
- Patient has given free and informed consent and signed the consent form
- Patient is a member or beneficiary of a health insurance plan
You will not qualify if you...
- Subject currently excluded by participation in a previous study
- Subject unable to give consent or receive informed information
- Patient under legal protection such as safeguard of justice or guardianship
- Known allergy to dexmedetomidine or other drugs
- Contraindication to general anesthesia or outpatient management
- Patient treated with beta-blocker, ACE inhibitor, or ARB2
- Patient with ASA score of 4
- Heart rate below 50 beats per minute
- Cardiovascular conditions including coronary insufficiency, obstructive cardiomyopathy, severe hypertension, or ventricular rhythm/conduction disorder
- Liver insufficiency (prothrombin rate under 70%, liver enzymes or bilirubin three times normal)
- Kidney insufficiency (clearance under 50 ml/min)
- Pregnant, giving birth, or nursing patients
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants receive induction of general anesthesia by administration of either dexmedetomidine or sufentanil during scheduled outpatient surgery.
1 surgical visit on the day of surgery
Duration - 7 days
Participants are monitored for recovery, pain, nausea, vomiting, and adverse events following surgery.
Follow-up visits or assessments on Days 0, 1, 2, and 7 after surgery
Trial Site Locations
Total: 1 location
1
CHU de Nîmes
Nîmes, France
Actively Recruiting
Research Team
Y
Yann Gricourt
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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