Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery (DEXCOEUR)

Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery: Single-center Prospective Randomized Double-blind Non-inferiority Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Dexmedetomidine; Hemodynamics; Ambulatory Care
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Sufentanil

• Study Type: Interventional
• Enrollment (Estimated): 594
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yann Gricourt; Phone Number: 04.66.68.30.50; Email: yann.gricourt@chu-nimes.fr

Study Locations

• France
  • Nîmes, France
    • Recruiting
    • CHU de Nîmes
    • Sub-Investigator: Philippe CUVILLON
    • Sub-Investigator: Nathalie VIALLES
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr
    • Principal Investigator: Yann GRICOURT
    • Sub-Investigator: Zahir AKKARI
    • Sub-Investigator: Mikael PERIN
    • Sub-Investigator: Pierre Baptiste Pierre Baptiste VIALATTE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine	Drug: Dexmedetomidine; Induction of general anesthesia by administration of dexmedetomidine 0.5µg/Kg (maximum dose 50 µg) in titration by bolus of 10µg intravenously over 5 minutes
Active Comparator: Sufentanil	Drug: Sufentanil; Induction of general anesthesia by administration of sufentanil 0.25µg/Kg (maximum dose 20 µg) intravenously at anesthetic induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative hemodynamic stability during anesthesia between groups	Incidence of mean arterial pressure < 60 mmHg	Within 60 minutes after induction

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Yann Gricourt, CHU de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine; Sufentanil
• Other Study ID Numbers: NIMAO/2022-1/YG01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No