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临床试验/CTRI/2025/01/078858
CTRI/2025/01/078858尚未招募Phase 3 4

A Prospective Randomized Comparative Study to Compare the Efficacy of Intratracheal Dexmedetomidine versus Intravenous Dexmedetomidine in Attenuating Periextubation Cough and Hemodynamic Stress Response during Tracheal Extubation under General Anaesthesia

Smt Bhikhiben Kanjibhai Shah Medical Institute and Research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月31日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To study the efficacy of attenuating peri-extubation cough using 4 point cough scale during tracheal extubation

研究概览

简要总结

A study to compare the efficacy of intra tracheal dexmedetomidine versus intravenous dexmedetomidine in attenuating peri extubation cough and hemodynamic responses during tracheal extubation under general anaesthesia

Objective is to study the efficacy of attenuating peri-extubation cough using 4 point cough scale during tracheal extubation,To stud the post operative sedation score, to study the haemodynamic stress responses during extubation, To study the duration of analgesia by Visual Analogue Score (VAS) score and side effects if any

Inclusion criteria

•Patients voluntarily willing to sign written & informed consent.

•Male or female patients between age group of 18 to 60 years of age.

•Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.

•Patients posted for elective surgeries under general anaesthesia.

Exclusion criteria

•Patients unwilling to participate in the study.

•Patients with American Society of Anaesthesiologists (ASA) physical status III,

IV

•Patients with Body Mass Index ≥ 30 kg/m2

•Patients with anticipated difficult airway & intubation.

•Patients with preexisting hoarseness or sore throat or URTI.

•Patients with cardiovascular disease, arrhythmias, heart blocks, or taking beta

blockers or any antihypertensive treatment.

•Patients with cerebrovascular, hepatic and renal disease.

•Patients using steroids or having history of asthma or COPD.

•Patients with history of allergy to an α-2 adrenergic agonist.

Pregnancy & lactating women

Site of studyS.B.K.S. Medical Institute and Research Centre, Sumandeep Vidhyapeeth University, Piparia, Vadodara, Gujarat

Study design  observational comparative study

Study Duration: The study will be initiated after obtaining permission from institutional ethics  committee till the achievement of the sample size or by 18 months whichever is earlier.

Data will be collected & tabulated. Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. As regard to numerical variables; tests like unpaired student–t test and/or ANNOVA will be used whenever appropriate for between-groups comparisons, while for categorical variables, chi–square test will be used. P value<0.05 will be considered statistically significant.

**Likely outcome/ Benefit :**This prospective comparative study will help us to compare the efficacy between intratracheal dexmedetomidine and intravenous dexmedetomidine in attenuating peri extubation cough and hemodynamic stress responses to tracheal extubation in patients undergoing surgeries under general  anaesthesia and will enable us to know which route of the dexmedetomidine drug is most beneficial in giving balanced general anaesthesia by having better outcomes in cough reflexes and hemodynamics and less post operative complications

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Patients voluntarilly willing to sign informed consent.
  • Male or female patients between 18 to 60 years of age.
  • Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.
  • Patients posted for elective surgeries under general anaesthesia.

排除标准

  • Patients unwilling to participate in the study.
  • Patients with American society of Anesthesiiologist (ASA) physical status III, IV, V
  • Patients with Body Mass Index ≥ 30 kg/m2
  • Patients with anticipated difficult airway& intubation.
  • Patient with preexisting hoarseness or sore throat or upper respiratory tract infection.
  • Patients with cardiovascular diseases, arrhythmias, heart blocks, or taking beta blockers or any antihypertensive treatment.
  • Patients with cerebrovascular, hepatic and renal diseases.
  • Patient using steroids or having history of asthma or COPD.
  • Patients with history of allergy to an α-2 adrenergic agonist
  • Pregnancy & lactating women.

结局指标

主要结局

To study the efficacy of attenuating peri-extubation cough using 4 point cough scale during tracheal extubation

时间窗: At time of awareness | At time of Extubation | After extubation | At 1 min | At 2 min | At 3 min | At 5 min

次要结局

  • To study the post operative sedation score(Ramsay Sedation Score (RSS) will be recorded till the patient achieve RSScore 2)
  • To study the haemodynamic stress responses during extubation(Preoperative)
  • To study the duration of analgesia by Visual Analogue Score (VAS) score and side effects if any(VAS will be recorded till the patient achieves VAS 4)

研究者

发起方
Smt Bhikhiben Kanjibhai Shah Medical Institute and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Vishal Babubhai Hadiya

Smt.Bhikhiben Kanjibhai Shah Medical Institute & Research Centre

研究点 (1)

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