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临床试验/CTRI/2024/06/068859
CTRI/2024/06/068859尚未招募不适用

Comparison of recovery profile of Desflurane Vs Sevoflurane in patients undergoing FESS surgery under General Anaesthesia

Shree Krishna Hospital Anand1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年6月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
38
试验地点
1
主要终点
to evaluate the recovery profile in patients undergoing FESS surgery under general anaesthesia

研究概览

简要总结

Patient undergoing FESS surgery under general anesthesia will be recruited to participate in this study.

In group D Desflurane will be used as inhalation agent and In group S Sevoflurane willbe used as inhalation agent.

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. In the preoperative room, after confirming the NBM hours and checking the vitals, both the groups will receive loading dose of injection Dexmedetomidine 1 mcg/kg over 20 minutes in preoperative room and continued intraoperatively in the dose of 0.2mcg-0.7mcg/kg/hr according to hemodynamics. In the operation theatre, after attaching monitors, premedication with injection Fentanyl 2 mcg/kg and injection Loxicard 2% 1.5 mg/kg intravenously will be given before the procedure. Induction for both groups will be achieved by Injection Propofol 2 mg/kg iv . After performing check ventilation, succinyl choline 2 mg/kg will be administered intravenously to both groups to aid in intubation. Oral intubation will be done with PC ETT of appropriate size through conventional laryngoscope. Intermediate muscle relaxation will be achieved with Vecuronium 0.1 mg/kg. Throat pack will be inserted. For maintenance of anaesthesia, In Group D patients, anaesthesia will be maintained with oxygen, air and Desflurane, and in Group S patients anaesthesia will be maintained with oxygen, air and Sevoflurane. Intraoperative muscle relaxation will be maintained with Vecuronium 0.05 mg/kg. The initial inspired concentration of desflurane and sevoflurane will be adjusted to maintain MAP value less than 20% of baseline value . Oxygen saturation and end tidal carbon dioxide values will be monitored continuously. Heart rate, blood pressure will be recorded every 5 min during surgery. Injection ondansetron 4 mg and Injection Paracetamol 1 gm iv will be given at end of surgery. Sevoflurane/desflurane will be discontinued at the end of surgery and time will be noted, throat pack will be removed and 100% oxygen will be delivered. Residual neuromuscular blockade will be reversed using Glycopyrrolate 0.01mg/kg iv and Neostigmine 0.05 mg/kg iv.

The times from discontinuing inhalation agent to eye opening, tracheal extubation, obeying verbal commands, as well as the time to orientation to name will be assessed at 30-60 s intervals. The duration of anesthesia and surgery will be recorded.

On arrival in recovery room, heart rate, blood pressure and oxygen saturation will be monitored until the patient is fully awake. If required iv analgesic will be given for post operative pain relief. The modified Aldrete scoring system will be used to access recovery from anesthesia.The modified Aldrete scores will be evaluated every 10 min after arrival in recovery room for the first half hour then every 15 or 30 mins until discharge. The time to achieve modified Aldrete Score >9 after discontinuation of the inhalation agent will be noted.

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
0.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients of all age group undergoing FESS surgery under general anaesthesia.

排除标准

  • Patients having history of mental dysfunction 2)Discontinuation of inhalation agent intraoperatively due to severe hypotension.

结局指标

主要结局

to evaluate the recovery profile in patients undergoing FESS surgery under general anaesthesia

时间窗: post operative period 0 to 6 hours

次要结局

未报告次要终点

研究者

发起方
Shree Krishna Hospital Anand
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Birva Khara

Pramukh Swami Medical College,Bhaikaka university

研究点 (1)

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