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临床试验/CTRI/2025/10/095681
CTRI/2025/10/095681尚未招募2/3 期

Low dose Dexmedetomidine versus Fentanyl for Attenuation of Emergence Delirium after General Anaesthesia in Adults: A Randomized Controlled Trial

Taba Annu1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2025年11月17日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
94
试验地点
1
主要终点
To compare the mean emergence delirium score in the two study groups

研究概览

简要总结

This study, Low dose Dexmedetomidine versus Fentanyl for attenuation of Emergence Delirium after general anaesthesia in adults: a randomised controlled trial will be undertaken in the Department of Anaesthesiology, RIMS, Imphal, from August 2025 to July 2027.  After obtaining institutional ethics committee approval and written informed consents from the patients, 94 patients will be randomized into two groups. Group A patients will be started on Inj. Fentanyl 1mcg per kg IV bolus plus Inj. Dexmedetomidine 0.2 mcg per kg per hr IV infusion. Group B patients will receive a Fentanyl 1 mcg per kg IV bolus plus a Fentanyl 1 mcg per kg per hr infusion following induction of anaesthesia with propofol and maintenance with 50 percent Nitrous oxide in oxygen with Sevoflurane 0.6 to 1.5 percent to titrate the BIS value to 40 – 60 and ETCO2 30-35 mmHg. Infusion drugs will be stopped 15-20 minutes before the end of skin closure and inhalational agents will be cut-off 5-10 minutes before end of skin closure. Reversal of residual neuromuscular blockade will be done when the end tidal anaesthetic agent concentration is less than MAC-Awake. Data will be collected and tabulated in excel format for analysis using SPSS. Data will be analysed using appropriate statistics and a p-value of less than 0.05 will be considered significant

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex 18- 60 years of age American Society of Anaesthesiologists physical status I or II Elective surgery under general anaesthesia Pre-operative MMSE (Mini-Mental state Examination) score more than or equal to 24 BMI less than or equal to 30 kg per m2.

排除标准

  • Patient’s refusal to sign a written informed consent.
  • Severe neurological or psychiatric disorders.
  • Patients on Tranquilizer or antidepressant medication.
  • Patients with history of smoking or alcohol consumption during the last 48 hours.
  • Patients with chronic lung disease.
  • Oto-laryngological procedures (Which poses additional challenges for emergence agitation).
  • Anticipated difficult airway (Multiple attempts of endotracheal intubation increases emergence delirium).

结局指标

主要结局

To compare the mean emergence delirium score in the two study groups

时间窗: Post extubation 20 minutes

次要结局

  • Postoperative nausea & vomiting (PONV)(1st hour)
  • Emergence time(1st hour)
  • Extubation time(End of surgery)
  • Time to first rescue analgesia(1st hour)

研究者

发起方
Taba Annu
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Taba Annu

Regional Institute of Medical Sciences Imphal Manipur

研究点 (1)

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