临床试验/CTRI/2025/09/095090

CTRI/2025/09/095090尚未招募4 期

"Comparison of Dexmedetomidine - Ketamine and Magnesium Sulphate - Ketamine Combination as a Sedation for Awake Fibreoptic Intubation in Adult Patients Undergoing Elective Surgeries Under General Anesthesia: A Prospective Randomised Double - Blinded Study."

Maharana Bhupal Government Hospital1 个研究点分布在 1 个国家目标入组 70 人开始时间: 2025年10月10日最近更新: 2025年9月18日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 70
试验地点: 1
主要终点: Cough score (severity of cough) during awake fibreoptic intubation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

We would like to compare intravenous dexmedetomidine-ketamine and intravenous magnesium sulphate-ketamine on intubating conditions during awake fibreoptic intubation in terms of cough score, intubating conditions, post intubation behaviour score or assessment, postoperative patient satisfaction score, ramsay sedation scale score, haemodynamics, side effects or complications if any. Kindly grant CTRI registration for our study as dexmedetomidine, ketamine and magnesium sulphate are FDA approved drugs.

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 55.00 Year(s)（—）
性别: All

入选标准

•Patients with ASA Physical Status I and II, Patients with Mallampati Class I and II.

排除标准

•Patient refusal Patients with history of allergy to study drugs Pregnancy and Lactation Patienst with nasal infection, complete obstruction and any contraindication to nasal intubation Patient with history of unstable angina or myocardial infarction and complete heart block Patients with any known cardiac, respiratory, renal or hepatic disease Psychiatric or neurological disease or seizure disorder Patients with history of bleeding disorders.

结局指标

主要结局

Cough score (severity of cough) during awake fibreoptic intubation

时间窗: During awake fibreoptic intubation(2 mins)

次要结局

Intubation comfort score(POst intubation behaviour score/assessment)

研究者

发起方

Maharana Bhupal Government Hospital

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Dr Santosh Choudhary

R.N.T Medical college

研究点 (1)

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