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临床试验/NCT06082856
NCT06082856招募中不适用

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

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 594 人开始时间: 2023年10月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
594
试验地点
1
主要终点
Intraoperative hemodynamic stability during anesthesia between groups

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Dexmedetomidine

Experimental

干预措施: Dexmedetomidine (Drug)

Sufentanil

Active Comparator

干预措施: Sufentanil (Drug)

结局指标

主要结局

Intraoperative hemodynamic stability during anesthesia between groups

时间窗: Within 60 minutes after induction

Incidence of mean arterial pressure \< 60 mmHg

次要结局

  • Intraoperative hemodynamic stability according to baseline mean arterial pressure between groups(Within 60 minutes after induction)
  • Intraoperative heart rate between groups(Within 60 minutes after induction)
  • Hemodynamic stability in the ICU between groups(Day 0 at discharge from ICU)
  • Occurrence of adverse events after surgery between groups(Day 2)
  • Intraoperative hypertensive episodes between groups(Within 60 minutes after induction)
  • Patient reported pain between groups(Day 7)
  • Immediate nausea and vomiting between groups(Day 0 during ICU stay)
  • Patient postoperative recovery between groups(Day 2)
  • Intraoperative vasopressor use between groups(Day 0, during surgery)
  • Intraoperative IV Atropine use between groups(Day 0, during surgery)
  • Patient satisfaction with perioperative management between groups(Day 2)
  • Failure of ambulatory management between groups between groups(Day 1)
  • Post-operative nausea and vomiting between groups(Day 7)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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