Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Anesthesia Clinical Trial

— DEXCOEUR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082856
• Other study ID #: NIMAO/2022-1/YG01
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2023
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Yann Gricourt
• Phone: 04.66.68.30.50
• Email: yann.gricourt[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 594
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory Care
• Anesthesia
• Dexmedetomidine
• Hemodynamics

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative hemodynamic stability during anesthesia between groups	Incidence of mean arterial pressure < 60 mmHg	Within 60 minutes after induction
Secondary	Intraoperative hemodynamic stability according to baseline mean arterial pressure between groups	Percentage of patients with 30% change in mean arterial pressure from baseline	Within 60 minutes after induction
Secondary	Intraoperative heart rate between groups	Percentage of patients with bradycardia =45bpm/min	Within 60 minutes after induction
Secondary	Intraoperative hypertensive episodes between groups	Percentage of patients with at least one episode of arterial hypertension (mean arterial pressure > 100mmHg)	Within 60 minutes after induction
Secondary	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	Day 0 at discharge from ICU
Secondary	Intraoperative vasopressor use between groups	Amount of IV Ephedrine (in mg) administered intraoperatively to maintain mean arterial pressure > 60 mmHg	Day 0, during surgery
Secondary	Intraoperative IV Atropine use between groups	Amount of IV Atropine (in µg) administered intraoperatively to maintain a heart rage > 45bpm	Day 0, during surgery
Secondary	Failure of ambulatory management between groups between groups	Percentage of patients hospitalized after surgery	Day 1
Secondary	Patient reported pain between groups	Pain reported on a 0-10 visual analog scale	Day 0
Secondary	Patient reported pain between groups	Pain reported on a 0-10 visual analog scale	Day 1
Secondary	Patient reported pain between groups	Pain reported on a 0-10 visual analog scale	Day 2
Secondary	Patient reported pain between groups	Pain reported on a 0-10 visual analog scale	Day 7
Secondary	Immediate nausea and vomiting between groups	Percentage of patients with nausea and vomiting according to use of Ondansetron IV	Day 0 during ICU stay
Secondary	Post-operative nausea and vomiting between groups	Percentage of patients reporting absence/presence nausea and vomiting	Day 0 at discharge from surgery
Secondary	Post-operative nausea and vomiting between groups	Percentage of patients reporting absence/presence nausea and vomiting	Day 1
Secondary	Post-operative nausea and vomiting between groups	Percentage of patients reporting absence/presence nausea and vomiting	Day 2
Secondary	Post-operative nausea and vomiting between groups	Percentage of patients reporting absence/presence nausea and vomiting	Day 7
Secondary	Patient postoperative recovery between groups	Quality of Recovery questionnaire (QoR-40) (score 0-200)	Day 2
Secondary	Patient satisfaction with perioperative management between groups	Evaluation of Experience of General Anesthesia questionnaire (EVAN-G) (score 5-100)	Day 2
Secondary	Occurrence of adverse events after surgery between groups	Absence/presence of the following adverse events: bleeding, hematoma or re-hospitalization	Day 2