Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Intraoperative hemodynamic stability during anesthesia between groups [Time frame: Within 60 minutes after induction]

Secondary outcome measures (12)

• Intraoperative hemodynamic stability according to baseline mean arterial pressure between groups [Time frame: Within 60 minutes after induction]
• Intraoperative heart rate between groups [Time frame: Within 60 minutes after induction]
• Intraoperative hypertensive episodes between groups [Time frame: Within 60 minutes after induction]
• Hemodynamic stability in the ICU between groups [Time frame: Day 0 at discharge from ICU]
• Intraoperative vasopressor use between groups [Time frame: Day 0, during surgery]
• Intraoperative IV Atropine use between groups [Time frame: Day 0, during surgery]
• Failure of ambulatory management between groups between groups [Time frame: Day 1]
• Patient reported pain between groups [Time frame: Day 0]
• Patient reported pain between groups [Time frame: Day 1]
• Patient reported pain between groups [Time frame: Day 2]
• Patient reported pain between groups [Time frame: Day 7]
• Immediate nausea and vomiting between groups [Time frame: Day 0 during ICU stay]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

France · 1 center

• CHU de Nîmes — Nîmes

Identifiers

NCT: NCT06082856 · NIMAO/2022-1/YG01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗