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临床试验/CTRI/2024/10/075284
CTRI/2024/10/075284招募中不适用

Effect of two different doses of Dexmedetomidine on extubation quality score during tracheal extubation in adult patients,a Comparative Study.

Smt Bhikiben Kanjibhai Shah Medical Institute and Research Cen1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年10月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
72
试验地点
1
主要终点
To study haemodynamics and respiratory response during extubation.

研究概览

简要总结

Effect of two different doses of dexmedetomidine on extubation quality score during tracheal extubation in adult patients-A comparative study

To study the effect of two different doses of dexmedetomidine on extubation quality score during tracheal extubation in adult patients.

Objective is to study the hemodynamic and respiratory response during extubation, sedation score after extubation and observe the adverse effect or side effect.

Inclusion criteria:  Patients willing to sign informed consent, male or female patients between 18 to 65 years of age, patients belonging to American Society of Anesthesiologists (ASA) physical status I & II and patients posted for elective surgeries under general anesthesia.

**Exclusion criteria:**·      Patients unwilling to participate in study, patients with Body Mass Index more than 29 Kg per m square, patient with arrhythmia, pregnancy and lactating women, patients belonging to American Society of Anesthesiologists (ASA) III and above.

We will be conducting this on 72 adults aged 18-60 yrs belonging to grade I & II of American Society of Anesthesiologists (ASA) classification who will undergo elective surgeries under general anesthesia. They will be divided into 2 equal groups with chit method.

Group D1 (0.3µg/kg) and Group D2 (0.5μg/kg) of 36 patients each based on clinical conditions and the study drug will be administered by the consultant anesthesiologist present in the operation theatre there prior to extubation. Post extubation haemodynamic parameters will be recorded at baseline before test drug, after test drug, during extubation and every 1 minute for first 5 minutes, then every 15 minutes up to 2 hours after extubation. The primary outcome included quality of extubation will be assessed by 5-point scale and will be recorded every 5minutes for 30 minutes and then every 30 minutes till 120 minutes.. Ramsay sedation score (RSS) will be recorded every 5minutes for 30 minutes and then every 30 minutes till 120 minutes.

Site of Study: Department of Anesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara

Study Design: Prospective, double blinded and 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.

Statistics: 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 wherever 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 outome/benifit:**This prospective and comparative  study will help us to compare the efficacy between two different doses of dexmedetomidine in attenuating hemodynamic responses to  endotracheal extubation in patients undergoing  surgeries under general anesthesia by having better outcome in hemodynamics.

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

  • Patients willing to sign informed consent Male or Female patients between 18 to 65 years of age Patients belonging to American Society of Anesthesiologists(ASA) physical status I & II Patients posted for elective surgeries under general anesthesia.

排除标准

  • Patients unwilling to participate in study.
  • Patients with Body Mass Index more than 29 Kg per m square Patient with arrhythmias Pregnancy and lactating women Patients belonging to American Society of Anesthesiologists (ASA) III and above.

结局指标

主要结局

To study haemodynamics and respiratory response during extubation.

时间窗: Preoperative | After test drug administration | After reversal | During extubation | After extubation | At 1 min | At 2 min | At 3 min | At 4 min | At 5 min | At 15 min | At 30 min | At 45 min | At 60 min | At 75 min | At 90 min | At 105 min | At 120 min

次要结局

  • To study sedation score after extubation or any side effects.(Ramsay sedation score (RSS) will be recorded every 5minutes for 30 minutes and then every 30 minutes till 120 minutes.)

研究者

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

Snehal Patel

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

研究点 (1)

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