Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Sufentanil

    Drug

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

Treatment groups

594 Participants
are divided into 2 treatment groups
Group A: DexmedetomidineExperimental treatment 1 intervention
Group B: SufentanilActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative hemodynamic stability during anesthesia between groups

Incidence of mean arterial pressure \< 60 mmHg

Time frame
Within 60 minutes after induction

Secondary outcomes

1

Intraoperative hemodynamic stability according to baseline mean arterial pressure between groups

Percentage of patients with 30% change in mean arterial pressure from baseline

Time frame
Within 60 minutes after induction
2

Intraoperative heart rate between groups

Percentage of patients with bradycardia ≤45bpm/min

Time frame
Within 60 minutes after induction
3

Intraoperative hypertensive episodes between groups

Percentage of patients with at least one episode of arterial hypertension (mean arterial pressure \> 100mmHg)

Time frame
Within 60 minutes after induction
4

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

Time frame
Day 0 at discharge from ICU

Other outcomes

Sponsors and contacts

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