Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Centre Hospitalier Universitaire de Nīmes594 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

594

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Intraoperative hemodynamic stability during anesthesia between groups

Incidence of mean arterial pressure \< 60 mmHg

Time frame: Within 60 minutes after induction

Secondary Outcomes

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

Intraoperative heart rate between groups

Percentage of patients with bradycardia ≤45bpm/min

Time frame: Within 60 minutes after induction

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

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

Intraoperative vasopressor use between groups

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

Time frame: Day 0, during surgery

Intraoperative IV Atropine use between groups

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

Time frame: Day 0, during surgery

Failure of ambulatory management between groups between groups

Percentage of patients hospitalized after surgery

Time frame: Day 1

Patient reported pain between groups

Pain reported on a 0-10 visual analog scale

Time frame: Day 0

Patient reported pain between groups

Pain reported on a 0-10 visual analog scale

Time frame: Day 1

Patient reported pain between groups

Pain reported on a 0-10 visual analog scale

Time frame: Day 2

Patient reported pain between groups

Pain reported on a 0-10 visual analog scale

Time frame: Day 7

Immediate nausea and vomiting between groups

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

Time frame: Day 0 during ICU stay

Post-operative nausea and vomiting between groups

Percentage of patients reporting absence/presence nausea and vomiting

Time frame: Day 0 at discharge from surgery

Post-operative nausea and vomiting between groups

Percentage of patients reporting absence/presence nausea and vomiting

Time frame: Day 1

Post-operative nausea and vomiting between groups

Percentage of patients reporting absence/presence nausea and vomiting

Time frame: Day 2

Post-operative nausea and vomiting between groups

Percentage of patients reporting absence/presence nausea and vomiting

Time frame: Day 7

Patient postoperative recovery between groups

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

Time frame: Day 2

Patient satisfaction with perioperative management between groups

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

Time frame: Day 2

Occurrence of adverse events after surgery between groups

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

Time frame: Day 2

Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts