Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

NCT06082856 | Recruiting

• 1 other identifier: NIMAO/2022-1/YG01
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Dexmedetomidine; Hemodynamics; Ambulatory Care

Outcome Measures

Primary Outcomes (1)

• Intraoperative hemodynamic stability during anesthesia between groups

  Incidence of mean arterial pressure \< 60 mmHg

  Within 60 minutes after induction

Secondary Outcomes (19)

• Intraoperative hemodynamic stability according to baseline mean arterial pressure between groups

  Within 60 minutes after induction

• Intraoperative heart rate between groups

  Within 60 minutes after induction

• Intraoperative hypertensive episodes between groups

  Within 60 minutes after induction

• Hemodynamic stability in the ICU between groups

  Day 0 at discharge from ICU

• Intraoperative vasopressor use between groups

  Day 0, during surgery

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Sufentanil

ACTIVE COMPARATOR

Drug: Sufentanil

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine

Sufentanil DRUG

Induction of general anesthesia by administration of sufentanil 0.25µg/Kg (maximum dose 20 µg) intravenously at anesthetic induction.

Sufentanil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, France

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Sufentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines

Study Officials

• Yann Gricourt

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yann Gricourt

CONTACT

04.66.68.30.50; yann.gricourt@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: October 19, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

FR (1)