Clinical trial NCT06082856: Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery
Official title: Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery: Single-center Prospective Randomized Double-blind Non-inferiority Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Dexmedetomidine
Hemodynamics
Ambulatory Care
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 594
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Ambulatory surgery is increasingly used in anesthesia. In case of general anesthesia, it is recommended to use anesthesia molecules with a short half-life and low doses of opiates to ensure a rapid awakening and to prevent nausea and vomiting by systematic administration of anti-emetics during the operation.

Opiates (including sufentanil) have recently been called into question because of the nausea and vomiting and the delay in waking up induced by these molecules. To combat these side effects, the authors have proposed either to reduce the doses or to substitute them with dexmedetomidine, a sedative antihypertensive drug. Recent studies have demonstrated that opiates used in general anesthesia can be replaced by dexmedetomidine. However, literature data are controversial concerning the hemodynamic impact. No study has compared the hemodynamic profile of opioid-free anesthesia with dexmedetomidine versus conventional anesthesia with opioids.

The ambulatory context lends itself to the use of dexmedetomidine because it is aimed at a population without strong cardiac pathology, concerns non-major interventions, with the need to optimize pain and side effects.

The study authors therefore wish to compare the effects of induction of general anesthesia with low-dose Dexmedetomidine versus sufentanil, on post-induction hemodynamic stability in scheduled outpatient surgeries. The investigators hypothesize that hemodynamic stability at induction of general anesthesia with low-dose dexmedetomidine is not inferior to that obtained with sufentanil in scheduled ambulatory surgeries.


Eligibility 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

Primary outcomes:
measure: Intraoperative hemodynamic stability during anesthesia between groups
timeFrame: Within 60 minutes after induction
Secondary outcomes:
measure: Intraoperative hemodynamic stability according to baseline mean arterial pressure between groups
timeFrame: Within 60 minutes after induction
measure: Intraoperative heart rate between groups
timeFrame: Within 60 minutes after induction
measure: Intraoperative hypertensive episodes between groups
timeFrame: Within 60 minutes after induction
measure: Hemodynamic stability in the ICU between groups
timeFrame: Day 0 at discharge from ICU
measure: Intraoperative vasopressor use between groups
timeFrame: Day 0, during surgery
measure: Intraoperative IV Atropine use between groups
timeFrame: Day 0, during surgery
measure: Failure of ambulatory management between groups between groups
timeFrame: Day 1
measure: Patient reported pain between groups
timeFrame: Day 0
measure: Patient reported pain between groups
timeFrame: Day 1
measure: Patient reported pain between groups
timeFrame: Day 2
measure: Patient reported pain between groups
timeFrame: Day 7
measure: Immediate nausea and vomiting between groups
timeFrame: Day 0 during ICU stay
measure: Post-operative nausea and vomiting between groups
timeFrame: Day 0 at discharge from surgery
measure: Post-operative nausea and vomiting between groups
timeFrame: Day 1
measure: Post-operative nausea and vomiting between groups
timeFrame: Day 2
measure: Post-operative nausea and vomiting between groups
timeFrame: Day 7
measure: Patient postoperative recovery between groups
timeFrame: Day 2
measure: Patient satisfaction with perioperative management between groups
timeFrame: Day 2
measure: Occurrence of adverse events after surgery between groups
timeFrame: Day 2
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Yann Gricourt
role: PRINCIPAL_INVESTIGATOR
References: