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临床试验/CTRI/2024/08/072486
CTRI/2024/08/072486尚未招募4 期

Propofol Total Intravenous Anaesthesia versus Sevoflurane Inhalational Anaesthesia on Haemodynamic Response Profile during Suspension Laryngoscopy in Adults undergoing Micro laryngeal Surgery.A Randomized Controlled Trial.

Sir Ganga Ram Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年9月7日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
42
试验地点
1
主要终点
Haemodynamic changes during suspension laryngoscopy (heart rate, Systolic blood pressure)

研究概览

简要总结

Micro-laryngeal surgery (MLS) aided by suspension laryngoscope is a short, microscopic surgical procedure. It results in a robust sympathetic response due to stimulation of the laryngeal tissues resulting in an undue haemodynamic stress: tachycardia, hypertension and arrhythmias. These haemodynamic responses though common and benign, rarely may result in fatal complications in patients with cardio-vascular co-morbidities. Hence, controlling these haemodynamic perturbations becomes of paramount importance. Of the various pharmacologic agents and techniques tried to attenuate the cardiovascular stress response during MLS under suspension laryngoscopy, two commonly used general anaesthetics, sevoflurane (an inhalational agent), and propofol (an intravenous agent) have found favour. Though both attenuate haemodynamic responses, the efficacy of neither is so well established. This randomised study proposes to evaluate propofol total intravenous anaesthesia (TIVA) versus sevoflurane inhalational anaesthesia on haemodynamic control profile in adult patients undergoing MLS using suspension laryngoscope.

All patients undergoing elective MLS will be screened, and those eligible will be enrolled. Enrolled patients will receive either propofol TIVA or sevoflurane inhalational anaesthesia. Demographic and clinical details of the patients will be noted. Haemodynamic changes (pulse rate and systolic blood pressure) during suspension laryngoscopy between them will be compared. Other intraoperative outcomes: frequency of adverse haemodynamic events (hypotension, hypertension, bradycardia, tachycardia), use of rescue drugs for maintaining haemodynamics (mephentermine, tri-nitroglycerine, atropine, metoprolol); and postoperative outcomes: postoperative sedation (assessed using Modified Observer’s Assessment of Alertness/Sedation scale [MOAA/S]) will be compared. We expect to enrol 42-patients in our study.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with laryngeal pathology undergoing microlaryngeal surgery (MLS) ASA physical status I and II.

排除标准

  • ASA GR III AND IV (uncompensated cardiovascular, hepatic, or renal disease)
  • Psychiatric or neurological disorder
  • Uncontrolled endocrine disease (diabetes mellitus, hypothyroidism)
  • Known allergy or hypersensitivity to the study drug.
  • Drug dependence or substance abuse
  • Refusal to informed consent.

结局指标

主要结局

Haemodynamic changes during suspension laryngoscopy (heart rate, Systolic blood pressure)

时间窗: At pre-induction, post-induction, post endotracheal intubation, every 3 minutes post insertion of rigid laryngoscope till its removal and every 30 minutes (for first 2 hours)

次要结局

  • Frequency of adverse haemodynamic effects(Use of rescue drugs for maintaining haemodynamics)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Prabhat Kumar Choudhary

Institute of Anaesthesiology, Pain & Perioperative Medicine

研究点 (1)

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