A Comparative Study Of The Efficacy Of Oral Ivabradine And Oral Gabapentin In Attenuating Haemodynamic Response To Laryngoscopy And Endotracheal Intubation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the effects of oral Ivabradine and Gabapentin on haemodynamic response such
研究概览
简要总结
It is a prospective, randomized, comparative study to assess the attenuation of hemodynamic response to pre operative administration of Oral Ivabradine and Oral Gabapentin for patients undergoing surgeries under General Anaesthesia. Hemodynamic parameters such as SBP, DBP, MAP and HR will be recorded throughout the perioperative period and the efficacy of the mentioned drugs will be assessed. Efficacy of the drugs will be compared and adverse effect profile will be assessed perioperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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 grade I or II fit patients.
- •Patients aged between 18 years and 60 years of age belonging to either sex
- •Haemodynamically stable patients with all routine investigations within normal limits and without any comorbidities.
- •Written informed consent from the concerned patient.
排除标准
- •Patients who have history of allergy to the drug being used for the study.
- •Patients who are not willing to participate in the study.
- •Patients on medications that affect the heart rate or blood pressure, pregnant patients.
- •Patients with ASA grade III and above physical status.
- •Patients who are aged less than 18 years and more than 60 years of age.
- •Patients who are posted for emergency procedures.
- •Patients who have psychiatric, neurological, cardiovascular disease, difficult airway or impairment of hepatic or renal function.
结局指标
主要结局
To compare the effects of oral Ivabradine and Gabapentin on haemodynamic response such
时间窗: Baseline (before administration of study drug), | preoperatively, | 0 minute (intubation) | 1 minute after intubation, | 3rd minute after intubation, | 5th minute after intubation, | 8th minute after intubation, | 10th minute after intubation, | 30 minutes, | 60 minutes | 90 minutes | 120 minutes | 2 hours post operatively, | 6 hours post operatively
as Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) during laryngoscopy and intubation.
时间窗: Baseline (before administration of study drug), | preoperatively, | 0 minute (intubation) | 1 minute after intubation, | 3rd minute after intubation, | 5th minute after intubation, | 8th minute after intubation, | 10th minute after intubation, | 30 minutes, | 60 minutes | 90 minutes | 120 minutes | 2 hours post operatively, | 6 hours post operatively
次要结局
- Determine which drug more effectively attenuates the haemodynamic response(Baseline (before administration of study drug),)
- To evaluate the incidence of adverse events & sedation related to the study drug.(Baseline (before administration of study drug),)
研究者
Akhilesh Mukerji
Dr D Y Patil Medical College Hospital and Research Centre