Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Anesthesia, Dexmedetomidine, Hemodynamics, Ambulatory Care

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* 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<br>|
| Active Comparator: Sufentanil<br> | Drug: Sufentanil<br>* Induction of general anesthesia by administration of sufentanil 0.25µg/Kg (maximum dose 20 µg) intravenously at anesthetic induction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative hemodynamic stability during anesthesia between groups | Incidence of mean arterial pressure < 60 mmHg | Within 60 minutes after induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Intraoperative heart rate between groups | Percentage of patients with bradycardia ≤45bpm/min | 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) | 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 | 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 | Day 0, during surgery | 
| Intraoperative IV Atropine use between groups | Amount of IV Atropine (in µg) administered intraoperatively to maintain a heart rage > 45bpm | Day 0, during surgery | 
| Failure of ambulatory management between groups between groups | Percentage of patients hospitalized after surgery | Day 1 | 
| Patient reported pain between groups | Pain reported on a 0-10 visual analog scale | Day 0 | 
| Patient reported pain between groups | Pain reported on a 0-10 visual analog scale | Day 1 | 
| Patient reported pain between groups | Pain reported on a 0-10 visual analog scale | Day 2 | 
| Patient reported pain between groups | Pain reported on a 0-10 visual analog scale | Day 7 | 
| Immediate nausea and vomiting between groups | Percentage of patients with nausea and vomiting according to use of Ondansetron IV | Day 0 during ICU stay | 
| Post-operative nausea and vomiting between groups | Percentage of patients reporting absence/presence nausea and vomiting | Day 0 at discharge from surgery | 
| Post-operative nausea and vomiting between groups | Percentage of patients reporting absence/presence nausea and vomiting | Day 1 | 
| Post-operative nausea and vomiting between groups | Percentage of patients reporting absence/presence nausea and vomiting | Day 2 | 
| Post-operative nausea and vomiting between groups | Percentage of patients reporting absence/presence nausea and vomiting | Day 7 | 
| Patient postoperative recovery between groups | Quality of Recovery questionnaire (QoR-40) (score 0-200) | Day 2 | 
| Patient satisfaction with perioperative management between groups | Evaluation of Experience of General Anesthesia questionnaire (EVAN-G) (score 5-100) | Day 2 | 
| Occurrence of adverse events after surgery between groups | Absence/presence of the following adverse events: bleeding, hematoma or re-hospitalization | Day 2 |