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临床试验/CTRI/2024/01/061850
CTRI/2024/01/061850尚未招募2 期

Comparison of ketofol and propofol as anaesthetic induction agent in patients undergoing supratentorial surgery.

Pt B D Sharma University of Health Sciences PGIMS1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年1月29日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
Changes in mean arterial pressure in both groups

研究概览

简要总结

The present prospective, randomized, double blind, interventional study will be done in the department of Anaesthesiology and Critical care in collaboration with department of Neurosurgery after obtaining approval PG Board of Studies and Institutional Ethical Committee. Witnessed written informed consent will be taken from patients then comparison of ketofol and propofol as anaesthetic induction agents in patients undergoing supratentorial surgery will be done.

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

  • Forty four patients of either sex in the age group 18-60 years belonging to ASA 1&2 scheduled to undergo elective supratentorial craniotomies with full GCS, size of lesion less than 5cm & midline shift less than 5mm under general anaesthesia will be enrolled in the study.

排除标准

  • The patients with refusal for study, hypertension, obesity, psychiatric disorder, pregnancy, lactation, other methods of brain relaxation being used or planned such as EVD will be excluded from the study.

结局指标

主要结局

Changes in mean arterial pressure in both groups

时间窗: 1.At Baseline | 2. 2 mins after induction | 3. 3 mins after intubation | 4. 5 mins after intubation | 5. 10 mins after intubation | 6. 3 mins after skull pin insertion | 7. 5 mins after skull pin insertion | 8. at the time of skin incision | 9. At the time of bone flap removal | 10. At the time of dural opening | 11. At the time of skin suturing | 12. 5 mins after extubation

次要结局

  • 1. Changes in heart rate(2. Brain relaxation score)

研究者

发起方
Pt B D Sharma University of Health Sciences PGIMS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Renu Bala

Pt. B. D. Sharma PGIMS

研究点 (1)

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