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临床试验/CTRI/2024/05/067027
CTRI/2024/05/067027尚未招募2/3 期

Comparison of ketamine to propofol in 1:2 versus 1:4 ketofol admixture on peri-intubation hemodynamics in exploratory laparotomy:a randomised comparative double blind clinical trial

UCMS and GTB Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月21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
90
试验地点
1
主要终点
To assess and compare incidence of hypotension between groups A and B

研究概览

简要总结

Preoperatively , a quick assessment would be made. In the OT, vital monitors will be attached ,iv fluids started and injection glycopyrrolate 0.2mgiv will be given.

Baseline blood pressure will be recorded as an average of three consecutive readings with difference <10% in the systolic blood pressure.

During preoxygenation, iv. Midazolam 0.04 mg/kg  will be given. Study drug will be injected over 30 seconds, dose titrated till predefined end point is reached. The end point would be loss of verbal response and loss of eyelash reflex. Succinylcholine 2 mg/kg will be given and trachea intubated. The whole procedure would be completed in 60 seconds. From the beginning of induction till confirmation of endotracheal tube placement by confirming bilateral air entry, the cricoid pressure would be applied.

The intubation conditions will be graded by the same anaesthetist who performed intubation. The assessment would  include  1- ease of laryngoscopy (easy: jaw relaxed, no resistance to blade insertion; fair: jaw not fully relaxed, slight resistance to blade insertion; difficult: poor jaw relaxation, active resistance of the patient to laryngoscopy), 2- vocal cord position (easy: abducted; fair: intermediate/moving; difficult: closed), and 3- reaction to insertion of the tracheal tube and cuff inflation (Diaphragmatic movement/coughing) (easy: none; fair: one to two weak contractions or movement for less than 5 seconds; difficult: more than two contractions and/or movement for longer than 5 seconds).

The intubation condition will be graded as excellent if all criteria are excellent, good if all criteria are either excellent or good, or poor if any criterion is graded as poor.

If after 3 attempts, intubation is unsuccessful, Proseal LMA will be inserted and case excluded from study.

An episode of hypotension (decrease in MAP > 20 % from baseline) will be  immediately managed by norepinephrine starting with  5µg/min infusion (Norepinephrine 80µg/ml) and titrated to MAP. At the end of 1 hour of intubation, the amount of norepinephrine consumed in either group will be noted and, if further required, continued while titrating with MAP.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Consenting patients aged 18-65 years posted for expolrative laparotomy under general anaesthesia 2)Hemodynamically stable patients.

排除标准

  • Patient with heart block on peri operative ECG 2)Patient with heart rate less than 50bpm 3)Hemodynamically unstable patient with mean arterial pressure less than 60mmHg 4)Patient on inotropes 5)Patient with signs and symptoms of raised intracranial tension 6)Patient with known allergy to any of the drug used.

结局指标

主要结局

To assess and compare incidence of hypotension between groups A and B

时间窗: Baseline 0 minute

次要结局

  • 1) HR, SBP, DBP immediately post induction,(2) HR, SBP, DBP immediately post intubation,)

研究者

发起方
UCMS and GTB Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ruchi Kapoor

UCMS and GTB Hospital

研究点 (1)

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