A comparative study of opioid free anaesthesia versus opioid based anaesthesia for post operative pain relief in patients undergoing laparoscopic surgeries- A double blinded randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Visual analogue score
研究概览
简要总结
After getting approval from the ethics committee, patients will be randomly allocated into 2 groups via computer generated group of numbers.
Group F - OPIOID FREE GROUP : will be receiving loading dose of IV. Dexmedetomidine 1mcg/ kg, IV. Lignocaine 2mg/kg in 100 ml normal saline in first 10 min before the induction of anesthesia and then followed by infusion IV. Dexmedetomidine 0.5mcg/kg/hr. till the end of the surgery.
Group O - OPIOID GROUP: will be receiving IV, Fentanyl 2mcg/kg in the first 10 min before induction of the anesthesia and then followed by infusion IV. Fentanyl 0.5mcg/kg/hr. till the end of the surgery.
After the pre oxygenation with 100% oxygen. induction achieved with Inj. Propofol 2.5mg/kg in both the groups, endotracheal intubation would be facilitated by INJ. Succinylcholine 1.5mg/kg and the airway will be secured with appropriately sized tube.
The lungs will be ventilated using 50% oxygen and nitrous oxide with depth of anesthesia maintained by isoflurane. the muscle relaxation will be maintained with Inj. Vecuronium 0.1mg/kg followed by top up doses.
Any event of bradycardia will be treated with Inj. Atropine 0.02mg/kg. and event of hypotension will be managed with Inj. Ephedrine 6mg bolus.
In both cases intrabdominal pressures will be maintained within 12-15mmhg. end tidal carbon dioxide monitoring will be maintained less than 35 mmhg. Both groups are given non opioid analgesic Inj. Paracetamol 1 gm which would be given at the end of the surgery.
Inj. Neostigmine+ Inj. glycopyrolate will be used as reversal and then patient shifted to post operative unit care.
post extubation monitoring will be maintained at 0,4,12,24 hrs. post operative vitals, pain score, will be assessed in all the patients.
the time for the first analgesic request and the total analgesic consumption will be then calculated and documented on the data collection Performa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Patient assessed and physically fit under the ASA category I and II.
排除标准
- •body mass index of more than 35 kg/m2 Patients with known allergy to drug used in this study.
- •Patients with renal and liver insufficiency, hyperthyroidism, hormonal therapy.
- •Patient with psychiatric illness Patient with chronic pain conditions.
- •Patient having cardiovascular diseases.
- •Patient who are not willing for the study.
结局指标
主要结局
Visual analogue score
时间窗: 24 hours
次要结局
- Assess the quality and duration of the postoperative analgesia by using Visual Analogue score(To assess the amount of total analgesics consumed in initial 24 hours.)
研究者
Dr Sneha ann johnson
Sri balaji vidyapeeth university