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临床试验/CTRI/2025/12/099857
CTRI/2025/12/099857尚未招募2/3 期

A Prospective Randomized Comparative Study For Evaluation Of Clinical Efficacy Of Oral Melatonin VS Oral Pregabalin Used As Premedication For Attenuation Of Hemodynamic Response To Laryngoscopy And Endotracheal Intubation In Patients Undergoing Head And Neck Surgery Under General Anaesthesia.

LLRM medical College1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月3日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1

研究概览

简要总结

This is prospective, randomized, double-blind interventional study to compare the efficacy of oral melatonin and oral pregabalin as premedication for attenuating the hemodynamic response to laryngoscopy and endotracheal intubation. Ninety ASA I–II patients undergoing elective head and neck surgery under general anesthesia are randomly allocated to receive melatonin, pregabalin, or placebo two hours before surgery.

Hemodynamic parameters, anesthetic drug requirements, and recovery profile is assessed and compared among the groups. The study aims to identify an effective and safe premedication for blunting sympathoadrenal responses during airway manipulation.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

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.(ASA) Grade I and II 2.Age: from18 to 60 years.
  • 3.Patients of either sex 4.Patients planned for Elective surgery receiving general anesthesia requiring tracheal intubation.
  • 5.Surgery duration: 30 minutes to 2 hrs.

排除标准

  • Patient Refusal
  • Patients with difficult airway MP grade 3 and
  • 3.Patient on Antidepressant and Anxiolytics.
  • Patients with coexisting systemic illness like respiratory and cardiovascular diseases, increased intracranial pressure.
  • Increased risk for preoperative aspiration of gastric contents (patients nil per oral not less than 6 hrs.).

研究者

发起方
LLRM medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Charu Singh

Lala Lajpat Rai Memorial Medical College Meerut

研究点 (1)

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