“A clinical comparative study to evaluate and compare the efficacy and safety of simple combination of analgesics i.e. Shiv mix with opioid for perioperative analgesia, hemodynamic and recovery profile in spine surgeries posted under general anesthesia.”
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- With Shiv mix, we expect less inhalational agent and less muscle relaxant.
研究概览
简要总结
200 adult patients of either sex of physical status ASA grade 1 and 2 undergoing elective surgery under general anaesthesia will be allocated into Group A and Group B of 100 patients using envelop method.
Group A: received Inj. Fentanyl prior to laryngoscopy and intubation.
Group B: received Inj. Lignocaine + Inj Paracetamol + Inj. Magnesium sulphate over a period of 20 minutes prior to laryngoscopy and intubation as premedication for perioperative analgesia.
Patients will be assigned to one of the following two groups:
Group A: received Inj. Fentanyl prior to laryngoscopy and intubation.
Group B: received Inj. Lignocaine 3 ml + Inj Paracetamol I gm + Inj. Magnesium sulphate 1 gram over a period of 20 minutes prior to laryngoscopy and intubation as premedication for perioperative analgesia.
•All patients will be explained about the sequence of anaesthetic procedure and a good IV access will be secured in the operation theater and all monitoring devices attached which included devices measuring heart rate, ECG, SpO2, non invasive blood pressure and respiratory rate. Baseline hemodynamic parameters, respiratory rate, ECG and SpO2 will be recorded.
•All patients will be given injection i.v. Ondansetron 4 mg, inj. i.v Ranitidine 50 mg, inj. i.v. Glycopyrolate 0.02 mg , inj. i.v. Midazolam 1 mg as premedication.
•Group A patients will be given Inj. i.v. Fentanyl 1-2 microgram per kilogram of the body weight and then induction agent i.e. inj. i.v. Propofol 2-3 mg per kilogram of the body weight and muscle relaxant i.e. inj. i.v. Vecuronium. After 4 minutes the laryngoscopy will be performed and the patient will be intubated, during the procedure the vitals will be recorded i.e. Pulse rate, Blood pressure (SBP, DBP and MBP), SpO2 and recorded repeatedly after every one minute till the confirmation of the endotracheal tube in the trachea and fixation. After that vitals will be recorded after every 3 mintues till the painting and draping of the desired surgical area. Inj. i.v. Diclofenac 75 mg will be given as a maintence analgesia. After that vitals will be recorded after every 5 minutes till the end of the Surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •200 patients of ASA grade I and 2 between the ages of
- •60 years, who underwent surgeries under general anaesthesia.
排除标准
- •Patients for whom any component of mixture is contraindicated Refusal to give consent History or family history of malignant hyperthermia ASA physical status –III or higher will be excluded Patients having history of convulsions, meningitis, infections, anaemia (Hb % <9 gm/dl) or any congenital heart disease Patients having hepatic, renal or neuromuscular disease Patients having respiratory system disease.
结局指标
主要结局
With Shiv mix, we expect less inhalational agent and less muscle relaxant.
时间窗: Patients satisfaction after surgery. | Demand for first rescue analgesia
次要结局
未报告次要终点