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临床试验/CTRI/2025/04/084594
CTRI/2025/04/084594招募中2 期

Use of Equilibriation point of Sevoflurane and Desflurane as a changeover point to low flow anesthesia- a randomised prospective comparative study on Breast cancer surgeries

Dr Rohit Nataraj Upadhyay1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月20日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
To compare equilibration point of Sevoflurane and Desflurane as a switch over point to low flow anesthesia

研究概览

简要总结

The study is a randomised prospective comparative study between two inhalational agents and switchover to inhalational agents Preoxygenation will be done for 3 minutes with 100% oxygen at 10 litre/min. Inj. Midazolam 0.02mg/kg and Inj. Fentanyl 1mcg/kg will be given as premedications. Patient will be induced with Inj. Propofol 2 mg/kg iv. After adequacy of mask ventilation is checked, Inj. Vecuronium 0.1 mg/kg iv will be administered.

Patient will be intubated with a cuffed endotracheal tube of appropriate size and tube position will be confirmed by End Tidal CO2 (EtCO2) waveform and bilateral equal air entry confirmed by auscultation, secured and connected to the ventilator.

Ventilation will be started at FiO2 of 40-50%, with tidal volume of 7ml/kg body weight on Volume Control (VC) mode, a high fresh gas flow of 6 lts/min (in ratio 40:60, O2:N2O) with dial concentration of 1.3 times the age specific MAC with either Sevoflurane (Group A)or Desflurane (Group B) will be set. The inspired (Fi) and expired (Fe) gas concentration will be noted till a ratio of 0.8 is achieved (equilibration point).

Once the set ratio is achieved, the flow will be reduced to 750ml. Arterial blood gases and time will be noted down. Dial concentration of anesthetic agent will noted and will be changed if needed to maintain age specific MAC of 1. Patient will be maintained on Inj Vecuronium 0.025mg/kg iv. Inj Fentanyl 0.5mcg/kg iv will be given as and when need for analgesia arises.In case inspired O2 concentration fall < 40%, it will be corrected by increasing FiO2 to 55-60%.

Hemodynamic parameters like Systolic BP (SBP), Diastolic BP (DBP), Heart rate (HR) , SpO2, inspired (Fi) and expired (Fe) gas concentration of O2, N2O, Sevoflurane/ Desflurane, mean time to achieve equilibration time of the volatile agent will be monitored for every minute for the first 5 minutes followed by every 5 minutes for 30 mins and there on every 15 minutes till the time of extubation.

At the end of surgery (at the time of the completion of the last stitch) N2O and inhalational agent will be switched off. Once the reversal criteria is obtained Inj Neostigmine 0.05mg/kg iv and Inj Glycopyrrolate 0.01mg/kg iv will be given.

When extubation criteria is met patient will be extubated. Recovery time will be noted as time from discontinuation of inhalation agent to the time patient can follow verbal commands. Any critical events of occurred will be noted down and tackled. Patients will be monitored in PACU for 3 hours post-operatively.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 20 and 60 years Willing to informed consent Belonging to ASA 1 and ASA 2 Body Mass Index (BMI) between 18.5 and 25 kg/m2.

排除标准

  • Patient not willing to give consent Belonging to ASA 3 and 4.

结局指标

主要结局

To compare equilibration point of Sevoflurane and Desflurane as a switch over point to low flow anesthesia

时间窗: within the time period of the surgery intraoperatively

次要结局

  • Arterial blood gas variation due to low flow anesthesia(1. immediately after changeover to low flow anesthesia)
  • Hemodynamic parameters(every 5 minutes for first 15 minutes, every 10 minutes for next half hour & 15 minutes till end of the surgery)
  • Washout time of inhalational agent(after the last suture till the patient responds & follows the verbal commands)

研究者

发起方
Dr Rohit Nataraj Upadhyay
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rohit Nataraj Upadhyay

Kidwai Memorial Institute of Oncology

研究点 (1)

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