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临床试验/CTRI/2025/07/090710
CTRI/2025/07/090710尚未招募不适用

AN OBSERVATIONAL STUDY TO EVALUATE THE EFFECTS OF IV NALBUPHINE IN PREVENTING STRESS RESPONSE OF LARYNGOSCOPY AND TRACHEAL INTUBATION IN COMPARISON TO IV LIGNOCAINE.

Shree Krishna Hospital1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
54
试验地点
1
主要终点
To prevent hemodynamic stress response to

研究概览

简要总结

This observational study, conducted at Shree Krishna Hospital, Karamsad, aims to compare the efficacy of intravenous nalbuphine (0.2 mg/kg) versus lignocaine (1.5 mg/kg) in preventing the stress response—such as tachycardia and hypertension—associated with laryngoscopy and tracheal intubation in patients undergoing elective surgery under general anaesthesia. With a sample size of 54 ASA grade I–III patients aged 18–65 years, the study investigates not only the primary outcome of hemodynamic stability during and after intubation but also the secondary outcomes, including nalbuphine’s potential to reduce propofol requirements. Participants are randomized into two groups, and standard anaesthetic protocols are followed, with vital signs monitored for 10 minutes post-intubation. Literature review suggests that while nalbuphine is effective in attenuating the pressor response with fewer side effects and better cardiovascular stability, fentanyl may be more potent in some cases. Lignocaine has also been shown to blunt reflexes but with less consistent hemodynamic control. The study is ethically approved, involves no additional patient cost, and maintains strict confidentiality. Findings are expected to contribute to optimizing anaesthetic protocols, guiding drug selection, and improving patient outcomes through better stress response management during airway manipulation.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient undergoing elective surgeries requiring general anesthesia and tracheal intubation
  • Patients Belonging to ASA grade 1 2 and 3.

排除标准

  • Patients unwilling to participate
  • Patients belonging to ASA grading 4,5
  • Patient with severe renal, hepatic, cardiovascular or respiratory disease
  • Pregnant and Lactating women
  • Patient with history of allergies to the related drugs.
  • Patients with Difficult airway and Laryngoscopy.

结局指标

主要结局

To prevent hemodynamic stress response to

时间窗: 0 to 10 mins

laryngoscopy and intubation

时间窗: 0 to 10 mins

次要结局

  • 1. To Study the dose sparring effect of IV nalbuphine on the amount of propofol used(during induction of General Anaesthesia.)

研究者

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

Dr Alpa Patel

Pramukh Swami Medical College,Bhaikaka university

研究点 (1)

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