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临床试验/CTRI/2019/04/018478
CTRI/2019/04/018478已完成不适用

Comparison of recovery profiles of patients undergoing lumbar laminectomy under propofol, sevoflurane or desflurane anesthesia. A randomized, prospective, clinical, comparative study

SGPGI1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年4月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
1)To compare the preoperative versus postoperative cognitive and psychomotor recovery profiles of patients undergoing lumbar laminectomy and discectomy under general anaesthesia maintained with propofol, sevoflurane or desflurane.

研究概览

简要总结

This prospective randomized clinical observational study aims to compare the postoperative cognitive and psychomotor recovery profiles of patient undergoing lumbar laminectomies under propofol, sevoflurane and desflurane anaesthesia. It utilises the Mini Mental status examination, Treiger Dot test and Digit Substitution test which are administered to the patients preoperatively and then in the post operative period ( at given time intervals) and their scoring which are reflective of their recovery characteristics are then recorded and analyzed later. As a secondary measure, the time taken to achieve discharge like recovery (Modified Aldrete score 9) and the incidences of side effects and the satisfaction levels of patients are also recorded.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA grade I and II 2.Age between 18 to 65 year 3.Patients of either gender 4.Education level minimum up to 8th standard 5.Single or two level disease necessitating decompression/discectomy without instrumentation.

排除标准

  • 1.Patient refusal 2.Inability to read or speak or communicate 3.Patients with psychiatric disorders/behavioral impairment or on antipsychotic drugs 4.Patients with significant hepatic, cardiovascular,pulmonary or renal disorders 5.Morbid obesity 6.Patients with allergy to study drugs or history of malignant hyperthermia 7.Chronic drug/alcohol abuse.

结局指标

主要结局

1)To compare the preoperative versus postoperative cognitive and psychomotor recovery profiles of patients undergoing lumbar laminectomy and discectomy under general anaesthesia maintained with propofol, sevoflurane or desflurane.

时间窗: Thrice preoperatively. Post extubation at 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours and at 4 hours.

次要结局

  • 1)To compare the incidences of postoperative complications like headache, giddiness, nausea, vomiting or pain at injection sites.(2)To compare the time taken by subjects administered these three anaesthetic regimens to achieve a modified Aldrete’s Score of 9.)

研究者

发起方
SGPGI
申办方类型
Research institution and hospital

研究点 (1)

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