Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06082856

Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-06-06

594

Participants Needed

1

Research Sites

119 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with scheduled surgery under general anesthesia for oral, orthopedic, urological, digestive, or gynecological surgeries
  • Patient has given free and informed consent and signed the consent form
  • Patient is a member or beneficiary of a health insurance plan
Not Eligible

You will not qualify if you...

  • Subject currently excluded due to participation in another study
  • Subject unable to give consent or receive informed information
  • Patient under legal protection such as safeguard of justice or state guardianship
  • Known allergy to dexmedetomidine or related drugs
  • Contraindication to general anesthesia or outpatient management
  • Patient treated with beta-blocker, ACE inhibitor, or ARB2
  • Patient with ASA score of 4
  • Heart rate below 50 beats per minute
  • Cardiovascular conditions such as coronary insufficiency, obstructive cardiomyopathy, severe hypertension, or heart rhythm/conduction disorders
  • Liver problems with prothrombin rate below 70% or elevated liver enzymes/bilirubin
  • Kidney problems with clearance below 50 ml/min
  • Pregnant, breastfeeding, or recently given birth

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

CHU de Nîmes

Nîmes, France

Actively Recruiting

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Research Team

Y

Yann Gricourt

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery | DecenTrialz