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临床试验/CTRI/2025/04/085880
CTRI/2025/04/085880尚未招募2 期

Comparison The Emergence Time After Discontinuation Of Sevoflurane With Fresg Gas Flo w 4L/min and 0.8L/min During Emergence While in Maintanence Phase The Fresh Gas Flow is kept at 0.8L/min

SHREE KRISHNA HOSPITAL1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年5月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
34
试验地点
1
主要终点
Primary objective: Comparing the emergence time after discontinuation of sevoflurane with fresh gas flow of 4l/min and 0.8l/min during emergence while in maintenance phase the fresh gas flow is kept at 0.8l/min

研究概览

简要总结

After obtaining institutional ethics committee’s approval and written informed consent patients undergoing surgeries under general anaesthesia will be recruited in this study. Participants will be allotted in to two groups through balanced randomization. A computer software viz. WINPEPI will be used for the randomization. The treatment allocation will be kept in a sealed opaque envelopes and they will be opened after written informed consent of eligible participants. Preoperative assessment will be done and written informed consent will be obtained from all the patients who fulfil the inclusion criteria. Patients will be randomly assigned to any one of the two groups.

Group H - FGF will be increased to 4L/min and sevoflurane  will be discontinued at the last skin stitch at the end of surgery and time of discontinuation of    sevoflurane , time of patient’s spontaneous movement , eye opening and time of    extubation is noted .

Group  S - FGF will be continued at 0.8L/min during emergence  and sevoflurane will be discontinued  20 minutes prior to last skin stitch  at the end of surgery and time of discontinuation till the patient’s spontaneous movement , eye opening and time of extubation will be noted  .

Method of assessment:

Variables to be assessed after discontinuation of sevoflurane

·         Time of eye opening(min)

·         Time of spontaneous movement (min)

·         Time of extubation (min)

·         End tidal concentration of sevoflurane  at various time –

1)      At sevoflurane discontinuation

2)      At eye opening

3)      At spontaneous movement

4)      At extubation

·         Entropy at various time-

1)      At sevoflurane discontinuation

2)      At eye opening

3)      At spontaneous movement

4)      At extubation

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
19.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patient undergoing surgery under General Anaesthesia with surgery hour more than 1 hour and using cuffed Endotracheal Tube.
  • Patient with ASA status I, II and III.
  • Patient weight between 30 to 80 kgs.

排除标准

  • 1.Patients refusing in taking part in the study 2.Neurological surgeries 3.Post operative patient who remain intubated or require elective ventilation 4.Patient of acute alcohol intoxication 5.Patient of diabetic keto acidosis.

结局指标

主要结局

Primary objective: Comparing the emergence time after discontinuation of sevoflurane with fresh gas flow of 4l/min and 0.8l/min during emergence while in maintenance phase the fresh gas flow is kept at 0.8l/min

时间窗: 0 minutes to 20 minutes

次要结局

  • 1. To compare time of eye opening after discontinuation of sevoflurane in both the groups(2. To compare time of spontaneous movement after discontinuation of sevoflurane in both the groups)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. Madhavi Chaudhari

PRAMUKH SWAMI MEDICAL COLLEGE,BHAIKAKA UNIVERSITY

研究点 (1)

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