Evaluating the effects of dexmedetomidine in outpatient surgery anesthesia
Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery: Single-center Prospective Randomized Double-blind Non-inferiority Study.
This study is testing if using dexmedetomidine instead of opioids during outpatient surgeries can help patients feel better and wake up more smoothly after anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 594 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 1 site (Nîmes) |
| Trial ID | NCT06082856 on ClinicalTrials.gov |
What this trial studies
This study investigates the hemodynamic effects of using dexmedetomidine as a substitute for opioids in outpatient surgeries requiring general anesthesia. It aims to compare the hemodynamic profiles of opioid-free anesthesia with dexmedetomidine against conventional anesthesia that includes opioids like sufentanil. The goal is to determine if dexmedetomidine can reduce side effects such as nausea and delayed awakening while maintaining stable hemodynamics. The study will involve patients undergoing various types of scheduled surgeries, ensuring informed consent is obtained prior to participation.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for general anesthesia for oral, orthopedic, urological, digestive, or gynecological surgeries.
Not a fit: Patients with contraindications to general anesthesia, significant cardiovascular comorbidities, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more efficient outpatient surgeries with fewer side effects for patients.
How similar studies have performed: While some studies have explored the use of dexmedetomidine in anesthesia, this specific comparison of opioid-free anesthesia versus conventional methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with scheduled surgery under general anesthesia for one of the following: oral, orthopedic, urological, digestive and gynecological surgeries. * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: * The subject is in a period of exclusion determined by a previous study * The subject is unable to give consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * Patient with a known allergy to dexmedetomidine or other drugs. * Patient with a contraindication to general anesthesia or outpatient management. * Patient treated with beta-blocker, ACE inhibitor or ARB2 * Patient with an ASA4 score. * Patient with HR \< 50 bpm. * Patient with the following cardiovascular comorbidities: coronary insufficiency, obstructive cardiomyopathy, severe hypertension, ventricular rhythm or conduction disorder. * Patient with hepatic (prothrombin rate \< 70%, liver enzyme/Bilirubin X 3) and/or renal (clearance \< 50 ml.min) insufficiency. * Pregnant, parturient or nursing patient
Where this trial is running
Nîmes
- CHU de Nîmes — Nîmes, France (Recruiting)
Study contacts
- Principal investigator: Yann Gricourt — CHU de Nimes
- Study coordinator: Yann Gricourt
- Email: yann.gricourt@chu-nimes.fr
- Phone: 04.66.68.30.50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.