Evaluation of the effect of Remifentanil vs Fentanyl as an adjunct to Propofol-based TIVA on Ease of Emergence & Intraoperative Haemodynamic Stability in patients undergoing Craniotomy : A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Ease of extubation:
研究概览
简要总结
With the very recent introduction of remifentanil into the Indian drug armamentarium, interest to utilise the drug in anesthesia practices for various surgeries including craniotomies has gained interest. This offered an opportunity to study the efficacy of remifentanil infusion versus fentanyl boluses as part of a TIVA regimen for patients posted for craniotomy.
We therefore want to test the hypotheses that remifentanil- propofol TIVA provides better extubating conditions and smooth emergence in craniotomy patients providing an optimum intraoperative haemodynamic control.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I, II, III Either gender BMI less than35 kg/m2 Any craniotomy for both supra-tentorial & infra-tentorial space occupying lesion GCS of 15/15 Duration of surgery of 4 hr.
排除标准
- •Patient refusal body mass index more than 35 kg/m2, GCS less than 15/15 H/o previous craniotomy If rapid postoperative return to normal consciousness was unlikely, owing to the location or size of lesion or postoperative ventilation is planned uncontrolled hypertension/ significant CAD/Â cardiac conduction block/ severe renal dysfunction/ CLD/ chronic obstructive pulmonary disease (GOLD 3/4) / neuropsychiatric disorders chronic pain requiring opioid analgesia, reported allergy to either study drug, patients having awake craniotomies or craniotomies requiring intraoperative CT/ magnetic resonance scanning (because the length of surgery will be much longer).
结局指标
主要结局
Ease of extubation:
时间窗: During extubation ( 0 min)
1.Time to eye opening
时间窗: During extubation ( 0 min)
2.Time to extubation
时间窗: During extubation ( 0 min)
3.Cough
时间窗: During extubation ( 0 min)
4.Sedation
时间窗: During extubation ( 0 min)
5.Pain
时间窗: During extubation ( 0 min)
次要结局
- Heart rate(At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr)
- Systolic blood pressure(At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr)
- Diastolic blood pressure(At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr)
- Mean arterial blood pressure(At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr)
研究者
Dr Eesha Banerjee
Institute of Neurosciences Kolkata