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NCT Number: NCT06082856

Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes

Nîmes, France

Location status: Recruiting

Location contact

Anissa Megzari

CONTACT

[email protected]

04.66.68.42.36

Mikael PERIN

SUB_INVESTIGATOR

Nathalie VIALLES

SUB_INVESTIGATOR

Philippe CUVILLON

SUB_INVESTIGATOR

Pierre Baptiste Pierre Baptiste VIALATTE

SUB_INVESTIGATOR

Yann GRICOURT

PRINCIPAL_INVESTIGATOR

Zahir AKKARI

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Intraoperative hemodynamic stability during anesthesia between groups

    Time frame: Within 60 minutes after induction

    Incidence of mean arterial pressure < 60 mmHg

Secondary outcomes

  1. Intraoperative hemodynamic stability according to baseline mean arterial pressure between groups

    Time frame: Within 60 minutes after induction

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

  2. Intraoperative heart rate between groups

    Time frame: Within 60 minutes after induction

    Percentage of patients with bradycardia ≤45bpm/min

  3. Intraoperative hypertensive episodes between groups

    Time frame: Within 60 minutes after induction

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

  4. Hemodynamic stability in the ICU between groups

    Time frame: Day 0 at discharge from ICU

    Percentage of patients with at least one episode of a Systolic Blood Pressure below 90mmHg (SBP < 90mmHg) in the ICU

  5. Intraoperative vasopressor use between groups

    Time frame: Day 0, during surgery

    Amount of IV Ephedrine (in mg) administered intraoperatively to maintain mean arterial pressure > 60 mmHg

  6. Intraoperative IV Atropine use between groups

    Time frame: Day 0, during surgery

    Amount of IV Atropine (in µg) administered intraoperatively to maintain a heart rage > 45bpm

  7. Failure of ambulatory management between groups between groups

    Time frame: Day 1

    Percentage of patients hospitalized after surgery

  8. Patient reported pain between groups

    Time frame: Day 0

    Pain reported on a 0-10 visual analog scale

  9. Patient reported pain between groups

    Time frame: Day 1

    Pain reported on a 0-10 visual analog scale

  10. Patient reported pain between groups

    Time frame: Day 2

    Pain reported on a 0-10 visual analog scale

  11. Patient reported pain between groups

    Time frame: Day 7

    Pain reported on a 0-10 visual analog scale

  12. Immediate nausea and vomiting between groups

    Time frame: Day 0 during ICU stay

    Percentage of patients with nausea and vomiting according to use of Ondansetron IV

  13. Post-operative nausea and vomiting between groups

    Time frame: Day 0 at discharge from surgery

    Percentage of patients reporting absence/presence nausea and vomiting

  14. Post-operative nausea and vomiting between groups

    Time frame: Day 1

    Percentage of patients reporting absence/presence nausea and vomiting

  15. Post-operative nausea and vomiting between groups

    Time frame: Day 2

    Percentage of patients reporting absence/presence nausea and vomiting

  16. Post-operative nausea and vomiting between groups

    Time frame: Day 7

    Percentage of patients reporting absence/presence nausea and vomiting

  17. Patient postoperative recovery between groups

    Time frame: Day 2

    Quality of Recovery questionnaire (QoR-40) (score 0-200)

  18. Patient satisfaction with perioperative management between groups

    Time frame: Day 2

    Evaluation of Experience of General Anesthesia questionnaire (EVAN-G) (score 5-100)

  19. Occurrence of adverse events after surgery between groups

    Time frame: Day 2

    Absence/presence of the following adverse events: bleeding, hematoma or re-hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Yann Gricourt

CONTACT

[email protected]

04.66.68.30.50

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: DEXCOEUR

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 13, 2023
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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