Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

NCT ID: NCT06082856

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 594 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2026-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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

Sufentanil

Group Type: ACTIVE_COMPARATOR

Sufentanil

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Sufentanil

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yann Gricourt

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

CHU de Nîmes

Nîmes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Yann Gricourt

Role: CONTACT

yann.gricourt@chu-nimes.fr

04.66.68.30.50

Facility Contacts

Anissa Megzari

Role: primary

drc@chu-nimes.fr

04.66.68.42.36

Other Identifiers

NIMAO/2022-1/YG01

Identifier Type: -

Identifier Source: org_study_id