Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Not Applicable

Recruiting

• Conditions: Ambulatory Care; Anesthesia; Dexmedetomidine; Hemodynamics
• Interventions: Drug: Dexmedetomidine; Drug: Sufentanil

• Registration Number: NCT06082856
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-13
• Study Start: 2023-10-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 594

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	-
Sufentanil	Sufentanil	-

Primary Outcome Measures

Name	Time	Method
Intraoperative hemodynamic stability during anesthesia between groups	Within 60 minutes after induction	Incidence of mean arterial pressure \< 60 mmHg

Secondary Outcome Measures

Name	Time	Method
Intraoperative hemodynamic stability according to baseline mean arterial pressure between groups	Within 60 minutes after induction	Percentage of patients with 30% change in mean arterial pressure from baseline
Intraoperative heart rate between groups	Within 60 minutes after induction	Percentage of patients with bradycardia ≤45bpm/min
Hemodynamic stability in the ICU between groups	Day 0 at discharge from ICU	Percentage of patients with at least one episode of a Systolic Blood Pressure below 90mmHg (SBP \< 90mmHg) in the ICU
Occurrence of adverse events after surgery between groups	Day 2	Absence/presence of the following adverse events: bleeding, hematoma or re-hospitalization
Patient satisfaction with perioperative management between groups	Day 2	Evaluation of Experience of General Anesthesia questionnaire (EVAN-G) (score 5-100)
Intraoperative hypertensive episodes between groups	Within 60 minutes after induction	Percentage of patients with at least one episode of arterial hypertension (mean arterial pressure \> 100mmHg)
Patient reported pain between groups	Day 7	Pain reported on a 0-10 visual analog scale
Immediate nausea and vomiting between groups	Day 0 during ICU stay	Percentage of patients with nausea and vomiting according to use of Ondansetron IV
Patient postoperative recovery between groups	Day 2	Quality of Recovery questionnaire (QoR-40) (score 0-200)
Intraoperative vasopressor use between groups	Day 0, during surgery	Amount of IV Ephedrine (in mg) administered intraoperatively to maintain mean arterial pressure \> 60 mmHg
Intraoperative IV Atropine use between groups	Day 0, during surgery	Amount of IV Atropine (in µg) administered intraoperatively to maintain a heart rage \> 45bpm
Failure of ambulatory management between groups between groups	Day 1	Percentage of patients hospitalized after surgery
Post-operative nausea and vomiting between groups	Day 7	Percentage of patients reporting absence/presence nausea and vomiting

Trial Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nîmes, France