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临床试验/NCT04761159
NCT04761159已完成4 期

Effect of Ketamin+Propofol Mixture on Postoperative Recovery

Cukurova University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2021年2月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
112
试验地点
1
主要终点
Delirium score

研究概览

简要总结

ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, Watcha score, FLACC score will record. Than all data will statistically analyse.

详细描述

ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery in this randomised controlled study. The participants will divide into the 4 groups with computered random generation. The Different combination of propofol+ketamin mixture will apply at the induction of anesthesia. The groups will assign as group I,II, III and IV. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. Fentanyl 1 microgram per kg and rocuronium 0.6 mg/kg will apply for anesthesia induction to the all participants. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, Watcha score, FLACC score will record. Than all data will statistically analyse.

研究设计

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

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA I-II patients
  • Underwent adenoidectomy-tonsillectomy surgery
  • Age between 3-12

排除标准

  • ASA III-IV patients
  • Age; under 3 years old
  • Age; above 12 years old.

研究组 & 干预措施

Ketofol1/1

Active Comparator

Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I to anesthesia induction.

干预措施: Ketamine (Drug)

Ketofol1/2

Active Comparator

propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II to anesthesia induction

干预措施: Ketamine (Drug)

Ketofol1/3

Active Comparator

propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III to anesthesia induction

干预措施: Ketamine (Drug)

propofol

Active Comparator

propofol 3 mg/kg will perform for anesthesia induction

干预措施: Ketamine (Drug)

结局指标

主要结局

Delirium score

时间窗: 30 minutes in PACU

Watcha scores will record till the patient discharge from the PACU.

次要结局

  • length of stay in PACU(30 minutes in PACU)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ebru biricik

associate professor

Cukurova University

研究点 (1)

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