Comparison Of Effects Of Remifentanil And Fentanyl On Hemodynamics And Recovery In Patients Undergoing Elective Craniotomy Under General Anaesthesia ,A Prospective Observational Single Center Double Blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.To compare effects of Remifentanil and Fentanyl on intraoperative hemodynamics . 2. To compare effects of Remifentanil and Fentanyl on recovery.
研究概览
简要总结
The study titled as Comparison of effects of Remifentanil and Fentanyl on hemodynamics and recovery in patients undergoing elective craniotomy under general anesthesia a prospective observational double blind study aims to determine whether remifentanil is superior to fentanyl in terms of maintaining hemodynamic stability and improving recovery in patients undergoing elective craniotomies. Craniotomy procedures require precise anesthesia management to ensure intraoperative stability and allow for early postoperative neurological assessment. Fentanyl, a commonly used opioid, has a longer half-life which may delay recovery, while remifentanil, due to its ultra short acting nature and unique metabolism, allows for quicker emergence. However, remifentanil provides minimal postoperative analgesia and its use in India has been relatively recent. This study seeks to fill the gap in Indian data by comparing the intraoperative and postoperative effects of these two drugs. The primary objectives are to compare the effects of remifentanil and fentanyl on intraoperative hemodynamics and recovery. The secondary objective is to assess additional analgesic requirements in the immediate postoperative period and observe any complications. This will be a prospective randomized double blind controlled trial conducted at PD Hinduja Hospital and MRC Mahim with a total sample size of 100 patients divided equally into two groups over 18 months. Patients aged 18 to 80 years undergoing elective craniotomy under general anesthesia will be included. After obtaining informed consent and completing a preoperative evaluation, patients will be randomized using computer generated chits into two groups: Group R receiving Remifentanil infusion and saline bolus, and Group F receiving Fentanyl bolus and saline infusion. Anesthesia for both groups will be standardized using Propofol, Sevoflurane and Vecuronium. Hemodynamic parameters will be recorded at specified intervals and postoperative outcomes such as recovery time pain scores and rescue analgesia needs will be evaluated. It is anticipated that remifentanil will offer better hemodynamic control and faster recovery than fentanyl. The study findings may offer insights into optimizing neurosurgical anesthesia practices for Indian patients by highlighting the comparative benefits of these two opioids.
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 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Age :18-80 Years Both Male And Non Pregnant Females Patients ASA I-III Glassgow Coma Scale 15/15.
排除标准
- •Refusing to participate Age less than 18 and more than 80 years BMI more than 35Kg/m2 Pregnant females Allergy to opioids ASA IV-V Emergency surgery.
结局指标
主要结局
1.To compare effects of Remifentanil and Fentanyl on intraoperative hemodynamics . 2. To compare effects of Remifentanil and Fentanyl on recovery.
时间窗: Mean Rate Pressure Product ,Systolic Blood Pressure ,Diastolic Blood Pressure,Heart Rate,Mean Arterial Presssure at points of maximal stimuli such as | Intubation,Pinning, Incision, Craniotomy,Dural Incision ,Extubation noted at 0min, 1min and 5 min.
次要结局
- Secondary objectives of the study is to assess the requirement of additional analgesics in immediate post operative period and to see if any complications.(Analgesic requirement post extubation at 0min,10min,20min.)
研究者
DrShwetal Goraksha
Dept. of Neuroanaesthesia, P.D.Hinduja Hospital and Medical Research Centre,Mahim
