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临床试验/CTRI/2024/01/061334
CTRI/2024/01/061334已完成4 期

Comparison of Intratracheal Dexmedetomidine versus Lignocaine on Attenuating Emergence Cough Response to Extubation in Patients Undergoing Craniotomy for Intracranial Tumour: A Multi-Arm Randomized Controlled Trial

Uttar pradesh university of medical sciences1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年1月15日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
45
试验地点
1
主要终点
1.To compare the effect of intratracheal dexmedetomidine and intratracheal lignocaine on the emergence cough response by using the emergence cough score

研究概览

简要总结

This randomized, double-blind, control study will be conducted on 45 patients after the institutional ethical committee approves.

The study will be carried out at our institute for over 12 months. Randomization will be done using a computer-generated random number table to get an equal number of patients in each group. Both patients and the anaesthesiologist assigned for data collection will be kept blind throughout the study. Different anaesthesiologists will be assigned to study and control drugs. All patients will be randomly allocated into 3 groups of 15 each.

· Group DX: Injection Dexmedetomidine (0.5 mcg/kg) diluted with 0.9% normal saline to make a volume of 5 ml will be instilled intratracheally into the endotracheal tube 15-20 min before the expected extubation.

· Group LG:  2 % lignocaine 1.5 mg/kg diluted with 0.9% normal saline to make a volume of 5 ml will be instilled intratracheally into the endotracheal tube 15-20 min before the expected extubation

· Group CN:  5 ml of 0.9% normal saline will be instilled intratracheally into the endotracheal tube 15-20 min before the expected extubation.

Emergence cough response, Hemodynamic parameters and Vas score will be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • ASA I or II class, BMI less than 30, Undergoing elective craniotomy for intracranial tumor under general anaesthesia.

排除标准

  • Patient Refusal
  • Renal impairment
  • Cardiorespiratory abnormalities 4.Bronchial asthma COPD
  • Restrictive lung diseases
  • Liver failure
  • Allergy to drugs will be used
  • Pregnancy-lactation.

结局指标

主要结局

1.To compare the effect of intratracheal dexmedetomidine and intratracheal lignocaine on the emergence cough response by using the emergence cough score

时间窗: 5 min after extubation

次要结局

  • Hemodynamic parameters Heart rate,Mean blood pressure, and Oxygen saturation(Baseline (T0))
  • VAS score(1 hr after extubation,)

研究者

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

Shipra Verma

Uttar Pradesh University of Medical Sciences, Saifai,Etawah

研究点 (1)

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