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临床试验/CTRI/2023/12/060833
CTRI/2023/12/060833尚未招募4 期

Comparison of Recovery Profile of Sevoflurane and Target Controlled Infusion of Propofol in Fibroadenoma Surgeries - A Randomised Controlled Trial

SRM1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
SRM
入组人数
90
试验地点
1
主要终点
To compare the recovery profile of patients between Target Controlled Infusion group, Sevoflurane group and Conventional Anaesthesia group using Clinical Recovery Score

研究概览

简要总结

A total of 90 patients belonging to the age group of 18-45 years, assessed under ASA I and ASA II, scheduled for fibroadenoma excision surgeries will be prospectively studied. In this double-blinded randomised controlled trial, a total of 90 participants will be allocated into three groups- Group A(TIVA), Group B(VIMA) and Group C(Conventional General Anaesthesia). All three groups will receive premedication with Inj. Glycopyrrolate 0.2mg IV, Inj. Ondansetron 4mg IV, Inj. Midazolam 0.04mg/kg IV. All patients will receive Inj. Fentanyl 2mcg/kg as analgesic and 100% O2 via face mask prior to LMA insertion. Patients will be induced according to the group that they have been allocated into. Standardised Proseal LMA is inserted with their size depending on the weight of the patients. All patients will be assessed for their recovery profile using Clinical Recovery Score postoperatively. After 24 hours, in the post operative period, PADSS Score will be assessed. Data collection will be done by observation and measurement of various parameters.

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
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Patients scheduled to undergo elective excision and biopsy of fibroadenoma
  • ASA I and II patients
  • Females aged 18-45 years
  • Patients with BMI less than 24.9
  • Patients assessed to have MPC I & II
  • Anticipated surgery duration of less than 1 hour.

排除标准

  • Patients refusal
  • Anticipated difficult airway
  • Patients with history of GERD
  • Patients with history of achalasia
  • Patients with history of oropharyngeal abscess or mass.

结局指标

主要结局

To compare the recovery profile of patients between Target Controlled Infusion group, Sevoflurane group and Conventional Anaesthesia group using Clinical Recovery Score

时间窗: 1hr, 6hr, 12hr, 24hr

次要结局

  • To monitor duration of hospital stay using PADSS Score(24hr)

研究者

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

Dr Nanditha Padikkasu

SRM Medical College Hospital and Research Centre

研究点 (1)

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