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临床试验/NCT07144007
NCT07144007招募中不适用

Van Yuzuncu Yil University Faculty of Medicine Ethics Committee

Yuzuncu Yıl University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年4月15日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Agitation status

研究概览

简要总结

To compare of prevention of emergence agitation in rhinoplasty with subanesthetic propofol and single dose dexmedetomidine

详细描述

The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 80 patients planned for elective rhinoplasty, aged 18-65 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each. All cases will receive routine preparation for general anesthesia. For anesthesia induction 0,03 mg/kg midazolam, 2 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be used. Anesthesia will be maintained with 60% air, 40% oxygen and 1 MAC sevoflurane. If intraoperatively needed, an additional dose of 0.5 mcg/kg fentanyl and 0.15 mg/kg rocuronium will be administered. If necessary, nicardipine infusion will be administered to provide controlled hypotension. Before the end of the surgery, 15 mg/kg paracetamol and 1 mg/kg tramadol will be administered for postoperative analgesia. After the nasal tampons are placed, one group will receive 0.5 mg/kg propofol, and the other group will receive 0.5 mcg/kg dexmedetomidine IV infusion over 10 minutes. 4 mg/kg sugammadex will be administered as a muscle relaxant reversal agent. The patient will be extubated when spontaneous breathing occurs and the patient opens their eyes with verbal stimulation. Agitation status will be assessed with the Richmond Agitation Sedation Scale (RASS) at 1 minute after extubation. Heart rate, systolic, diastolic, mean arterial pressures and saturation values will also be recorded before and after anesthesia induction, at the 5th, 10th, 15th, 20th, 25th, 30th minutes after intubation, at the 1st, 5th, 10th and 15th minutes after extubation. Additionally, if meaningless head and hand-arm movements, laryngospasm, nausea-vomiting, hypoxia (SpO2: <85%) occur at the 1st, 5th, 10th and 15th minutes after extubation, they will be recorded. Also recovery time will be recorded. All data will be recorded and statistical analysis will be made.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for rhinoplasty
  • Between 18-65 years
  • ASA I-II group

排除标准

  • Those who are outside the age range of 18-65
  • Those who are ASA III and above
  • Those with renal,hepatic, cardiac and respiratory diseases
  • Those with a known allergy to the medication to be used
  • Those who underwent urinary catheterization

研究组 & 干预措施

Dexmedetomidine (Group-D)

Active Comparator

Group-D: Dexmedetomidine group (n:40). In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing.

干预措施: Dexmedetomidine (Drug)

Propofol (Group-P)

Experimental

Group-P: Propofol group (n:40). In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing.

干预措施: Propofol (Drug)

结局指标

主要结局

Agitation status

时间窗: 1. minute after extubation

The effect on prevention of emergence agitation of propofol and dexmedetomidine will be evaluated by an anaesthetist with the Richmond Agitation Sedation Scale (RASS) at 1 minute after extubation

次要结局

  • Blood Pressure(perioperatively defined times)
  • Heart rate(perioperatively defined times)
  • oxygen saturation(perioperatively defined times)

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Emin Keskin

assistant professor

Yuzuncu Yıl University

研究点 (1)

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