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临床试验/CTRI/2013/08/003885
CTRI/2013/08/003885已完成4 期

A clinical study to evaluate the role of preoperative dexmedetomidine on attenuation of haemodynamic response to direct laryngoscopy and tracheal intubation

Govt Medical College and Hospital Sector Chandigarh1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年5月10日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
To study the effect of dexmedetomidine given before induction of anaesthesia on haemodynamic responses to direct laryngoscopy and tracheal intubation.

研究概览

简要总结

After approval of protocol by Institutional Ethics Committee and written informed consent, 80 adult patients of ASA (American Society of Anesthesiologists) physical status I /II of either sex, in the age group of 18 to 60 years who were scheduled to undergo elective surgery under general anaesthesia requiring tracheal intubation were included in the study. Using computer generated number table, patients were randomly divided into two groups of 40 each. Patients were allocated to one of the following group using sequentially numbered, sealed, opaque envelopes. Group I patients received dexmedetomidine, 0.5 microgram per kg i.v over 10 min and Group II patients received an equal volume of normal saline i.v over 10 min. After intubation anaesthesia was maintained with 33% of O2, 67% N2O and propofol infusion @ 50-80 microgram/kg/min. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), oxygen saturation (SpO2) , end tidal carbon dioxide (EtCO2)were continuously monitored and recorded at baseline, after completion of infusion of study drug, 5 min after completion of infusion of study drug, after induction, just before intubation, after intubation at 1 min, 3 min, 5 min, 10 min and 15 min. After recording the observations for 15 minutes, the rest of the anaesthetic procedure was carried out at the discretion of the attending anaesthesiologist. During study, the total dose of propofol required for induction was recorded. The side effects of the study drugs, if any, were also recorded. All the observations were recorded in the proforma attached and analyzed statistically using appropriate statistical test. Normality of data were checked by measures of skewness and kolmogorov smirnov tests. For normally distributed data students t- tests and for skewed data Mann Whitney U tests was applied for two groups. For time dependent changes, repeated measure ANOVA was applied. Data was presented as mean+-SD with p<.05 as significant.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor 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

  • 1.80 adult patients of ASA (American Society of Anesthesiologists) physical status I /II of either sex 2.Age group of 18 to 60 years 3.Scheduled to undergo elective surgery under general anaesthesia requiring endotracheal intubation.

排除标准

  • The following categories of patients were excluded from the study: 1.ASA grade III or more 2.Anticipated difficult airway 3.BMI >30 kg m 2 4.Preoperative medication with clonidine or alphamethyldopa 5.Hiatus hernia, gastroesophageal reflux 6.Known allergy to dexmedetomidine 7.Known case of coronary artery disease.

结局指标

主要结局

To study the effect of dexmedetomidine given before induction of anaesthesia on haemodynamic responses to direct laryngoscopy and tracheal intubation.

时间窗: Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Blood Pressure (MBP), Oxygen Saturation (SpO2), end tidal CO2 (EtCO2) were continuously monitored and recorded at following time intervals. | -Baseline | -After completion of infusion of study drug | -5 min after completion of infusion of study drug | -After induction | -Just before intubation | -After intubation at 1min, 3min, 5min, 10min and 15 min.

次要结局

  • 1)To study effect of dexmedetomidine on requirement of propofol at induction.(2)To study the adverse effects of dexmedetomidine.)

研究者

发起方
Govt Medical College and Hospital Sector Chandigarh
申办方类型
Government funding agency

研究点 (1)

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