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临床试验/CTRI/2025/05/086086
CTRI/2025/05/086086尚未招募2 期

Recovery characteristics after propofol based induction and maintenance of anaesthesia and sevoflurane based induction and maintenance anaesthesia in case of breast Lump Excision

Government Rajaji Hospital Madurai Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月5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
60
试验地点
1
主要终点
Time from end of procedure to 1.first spontaneous movement, 2.spontaneous eye

研究概览

简要总结

A surgical procedure performed on a patient admitted and discharged on the same day of surgery is an accepted practice to make hospital resources available for a greater number of patients as each patient gets discharged earlier from the hospital Rapid induction and recovery may lead to faster operating room turnover shorter recovery room stay and earlier discharge to home

Propofol has low lipid solubility and it gets eliminated rapidly from circulation Propofol is proven intravenous anaesthetic agent for day care procedures due to rapid onset of action with early recovery less incidence of post operative nausea and vomiting

Sevoflurane is non inflammable highly fluorinated anaesthetic agent with pleasant smell  It is potent hypnotic and fairly non irritant to the upper airway Sevoflurane has low blood gas co- efficient and produces characteristics of fast induction and rapid emergence from anaesthesia Inhalational induction using sevoflurane is rapid smooth and well tolerated in both children and adults

Propofol based anaesthesia is associated with hypotension, bradycardia pain on injection and may have allergic reaction Sevoflurane based anaesthesia provides relatively stable hemodynamics  Many studies have been done for phase I recovery but not much work done on phase II recovery with respect to ready for discharge home criteria So we conducted this study to compare recovery profile in both groups Our primary goal was to assess and compare phase I - early recovery time to achieve Aldrete score more than 9 in recovery room as well as phase 2  discharge to home recovery time to achieve PADSS score more than 9 in both the groups

Our secondary goal was to assess and compare induction quality in terms of LMA insertion conditions in both the groups

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • ASA 1 and ASA 2 Patient , those who are willing to give informed written consent.

排除标准

  • 1.Patient on sedative or opioid medications 2.Psychiatric or neurological disease 3.Susceptible to malignant Hyperthermia 4.Patient with significant cognitive impairment 5.Airway MPG 3 and 4 6.Lack of consent.

结局指标

主要结局

Time from end of procedure to 1.first spontaneous movement, 2.spontaneous eye

时间窗: Outcome assessments will be conducted at baseline pre-anaesthesia, intraoperative period, immediate postoperative period 30 min, 1 hr, 2 hrs, short-term recovery 4 hrs, 8 hrs, and on postoperative day 1 24 hrs after surgery.

opening

时间窗: Outcome assessments will be conducted at baseline pre-anaesthesia, intraoperative period, immediate postoperative period 30 min, 1 hr, 2 hrs, short-term recovery 4 hrs, 8 hrs, and on postoperative day 1 24 hrs after surgery.

3.removal of LMA

时间窗: Outcome assessments will be conducted at baseline pre-anaesthesia, intraoperative period, immediate postoperative period 30 min, 1 hr, 2 hrs, short-term recovery 4 hrs, 8 hrs, and on postoperative day 1 24 hrs after surgery.

4.Followed verbal commands 5.Became fully oriented to

时间窗: Outcome assessments will be conducted at baseline pre-anaesthesia, intraoperative period, immediate postoperative period 30 min, 1 hr, 2 hrs, short-term recovery 4 hrs, 8 hrs, and on postoperative day 1 24 hrs after surgery.

time and place

时间窗: Outcome assessments will be conducted at baseline pre-anaesthesia, intraoperative period, immediate postoperative period 30 min, 1 hr, 2 hrs, short-term recovery 4 hrs, 8 hrs, and on postoperative day 1 24 hrs after surgery.

次要结局

  • 1.Time to achieve Aldrete score more than 9 phase 1 recovery(2.Time to achieve PADSS score more than 9 Phase 2 recovery)

研究者

发起方
Government Rajaji Hospital Madurai Medical College
申办方类型
Government medical college

研究点 (1)

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