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临床试验/CTRI/2023/09/057535
CTRI/2023/09/057535尚未招募2 期

A Comparative study between Nebulisation with Dexmedetomidine and Lignocaine to Attenuate Laryngoscopic Response in a tertiary care Centre In West Bengal

Jagannath Gupta Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年9月25日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
130
试验地点
1
主要终点
Heart Rate (HR)

研究概览

简要总结

INTRODUCTION

Laryngoscopic response is characterised by a sudden surge in mean arterial pressure (MAP) and heart rate (HR), arising 30 seconds following direct laryngoscopy and intubation and approaches baseline in 10 minutes Various pharmacological agents are used to attenuate this noxious response with varied success.

Dexmedetomidine is a highly selective alpha-2 adrenergic agonist having sympatholytic, sedative, hypnotic and analgesic properties. Lignocaine is an amide synthetic local anaesthetic and used commonly for decreasing airway reflexes, bronchial hyperactivity and suppress the laryngoscopic response by inhibiting sensory C fibres of the airway Administration of drugs via nebulisation route provides greater surface area for absorption and better safety profile.

AIM AND OBJECTIVE

Aim: To explore two effective nebulisation regimens to attenuate laryngoscopic response

Objective: To compare heart rate and mean arterial blood pressure after nebulisation with dexmedetomidine or lignocaine post laryngoscopy

MATERIALS AND METHODS

MATERIALS

  1. Study Design: Prospective randomised double-blind study

  2. Study population: All ASA-PS: I, II patients posted for elective surgery under general anaesthesia

  3. Study duration: 1 year

  4. Sample size: N = 65 per group

  5. Parameters to be studied:

  6. Heart Rate (HR)

  7. Mean Arterial Pressure (MAP)

  8. Inclusion criteria:

  9. Patients aged between 18-60 years of either sex scheduled to undergo surgery under general anaesthesia

  10. American Society of Anaesthesiologists- Physical Status-1, 2 (ASA-PS-1, 2) patient

  11. Modified Mallampati grade 1 and 2

  12. Patients weighing between 45 kg and 75 kg

  13. Exclusion criteria:

  14. Patient refusal

  15. Patients with bleeding disorder

  16. Patients with known history of allergy, hypersensitivity

  17. Unanticipated difficult intubation (Laryngoscopy time >15 seconds)

  18. Patients with psychiatric disease

  19. Pregnant lady

  20. Study Group: Patients will be randomly assigned by computer generated number to one of the two groups- Group A and Group B

  21. Randomisation: Randomisation will be done by Sequentially numbered, opaque, sealed envelope (SNOSE) method

  22. Blinding: A two-operator technique will be used to maintain blinding.

  23. The principal investigator will record all the hemodynamic variables

  24. An anaesthesiologist, who is not involved in the study, will administer the nebulised drugs to the patient in the absence of principal investigator

Methods

Group A will be nebulised with Dexmedetomidine (1.5 μg/kg) dissolved in sterile water to make 5 ml and similarly Group B patients will be nebulised with Lignocaine (4.5 mg/kg) diluted with sterile water 30 minutes prior to induction of anaesthesia. All the vital parameters (HR, MAP and SPO2) will be recorded immediately after laryngoscopy and intubation (T0). The patient will be left undisturbed for 10 minutes; HR, MAP and SPO2 will be recorded for every 2 minutes post laryngoscopy till 10 minutes (T2, T4, T6, T8, T10). Rescue medication used will be Inj. Propofol integrated dose if rise in MAP>20% of baseline

研究设计

研究类型
Interventional

入排标准

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

入选标准

  • Patients aged between 18-60 years of either sex scheduled to undergo surgery under general anaesthesia
  • American Society of Anaesthesiologists- Physical Status-1, 2 (ASA-PS-1, 2) patient
  • Modified Mallampati grade 1 and 2
  • Patients weighing between 45 kg and 75 kg.

排除标准

  • Patient refusal
  • Patients with bleeding disorder
  • Patients with known history of allergy, hypersensitivity
  • Unanticipated difficult intubation (Laryngoscopy time >15 seconds)
  • Patients with psychiatric disease
  • Pregnant lady.

结局指标

主要结局

Heart Rate (HR)

时间窗: 1. Baseline vitals will be noted (TA) | 2. Vitals will be noted just after nebulisation (TB) | 3. All the vital parameters will be recorded before laryngoscopy & intubation (TC) | 4. All the vital parameters will be recorded immediately after laryngoscopy & intubation(T0) | 5. Vital parameters will be recorded for every 2 minutes after laryngoscopy and intubation till 10 minutes (T2, T4, T6, T8, T10)

Mean Arterial Pressure (MAP)

时间窗: 1. Baseline vitals will be noted (TA) | 2. Vitals will be noted just after nebulisation (TB) | 3. All the vital parameters will be recorded before laryngoscopy & intubation (TC) | 4. All the vital parameters will be recorded immediately after laryngoscopy & intubation(T0) | 5. Vital parameters will be recorded for every 2 minutes after laryngoscopy and intubation till 10 minutes (T2, T4, T6, T8, T10)

次要结局

未报告次要终点

研究者

发起方
Jagannath Gupta Institute of Medical Sciences
申办方类型
Private medical college

研究点 (1)

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