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临床试验/CTRI/2024/10/075178
CTRI/2024/10/075178尚未招募4 期

Variation in induction dose and time of propofol on administering inhaled nitrous oxide during induction A prospective randomized controlled study

Shri devaraj urs medical college1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年10月22日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
96
试验地点
1
主要终点
1) To evaluate the variation in induction dose of propofol on administering inhaled nitrous oxide

研究概览

简要总结

In this study, patients will undergo a comprehensive preoperative assessment, including detailed history taking, physical examination, and routine investigations. An intravenous line will be established, and IV fluids will be administered. The general anesthesia procedure will be explained, and informed consent will be obtained. Patients will be instructed to fast overnight and will receive Tab. Anxit 0.5mg the night before surgery to reduce anxiety. Upon entering the operating theatre, multipara monitors will be attached to record baseline vital signs, including heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and oxygen saturation (SpO2). Premedication will include Glycopyrrolate 0.2mg and Fentanyl 2mcg/kg, followed by 3 minutes of preoxygenation with 100% oxygen. Patients will be randomly assigned to one of two groups. Group A will receive a 70% nitrous oxide and 30% oxygen mixture via a Bain’s Circuit, alongside a propofol infusion at 30mg/min (3ml/min). Group B will receive 100% oxygen via a Bain’s Circuit with the same propofol infusion rate. Propofol infusion will be adjusted until the patient reaches an apneic state, with induction time recorded from the start of infusion to apnea and the total dose administered noted. Following this, succinylcholine (2mg/kg) will be administered for intubation with a cuffed endotracheal tube. Anesthesia will be maintained with a mixture of O2, N2O, and other inhalational agents. Hemodynamic parameters will be monitored and recorded at various intervals: preoperatively (T1), before propofol infusion (T2), and at 1-minute intervals up to 4 minutes after starting propofol infusion (T3-T6), at apneic state (T7), before intubation (T8), and after intubation (T9).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • 1.Patients proposed for elective surgical procedures under general anaesthesia.
  • 2.ASA 1 and 2.

排除标准

  • 1.Pregnant female.
  • 2.Morbidly obese patients.
  • 3.Patients with allergy to anesthetic agents.
  • 4.Patients with difficult airway.
  • 5.Patients with contraindications to the utilisation of N2O like increased intracranial pressure,obstruction of the bowel, pneumothorax, surgeries of the middle ear.

结局指标

主要结局

1) To evaluate the variation in induction dose of propofol on administering inhaled nitrous oxide

时间窗: The dose at which the patient achieves apnea - at 2min or 3 mins

次要结局

  • 2) To evaluate the variation in induction time of propofol on administering inhaled nitrous oxide(the time at which the patient achieves apnea,)

研究者

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

Siri chandana

Sri devraj urs medical college

研究点 (1)

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