COMPARISON OF DEXMEDETOMIDINE VS DEXAMETHASONE AS ADJUVANTS TO LEVOBUPIVACAINE IN ULTRASOUND GUIDED ERECTOR SPINAE BLOCK FOR PATIENTS UNDERGOING RENAL SURGERIES UNDER GENERAL ANAESTHESIA- A RANDOMISED CONTROLLED STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- To compare the postoperative analgesia in dexmedetomidine and dexamethasone group.
研究概览
简要总结
After obtaining ethics committee approval and written informed consent, patients undergoing renal surgeries (both laparoscopic renal surgeries and open renal surgeries) under general anesthesia will be recruited in this study. Participants will be randomly allotted in to two groups. A computer
software WINPEPI will be used for the randomization. The random allocation will be kept in a sealed opaque envelops and they will be opened after written informed consent of eligible participants. Routine detailed Pre-anesthesia check- up will be carried out in all patients. On arrival to operation theatre, standard monitoring- electrocardiogram (ECG), pulse oximetry (SPO2) and non-invasive blood pressure (NIBP), End tidal Carbon Dioxide (ETCO2) monitoring will be attached and baseline vitals will be noted. Under all aseptic precautions ultrasound guided erector spinae block will be performed using linear probe (0.5-6 MHz) in sitting position at T10 level for renal surgeries. After visualizing transverse process at T10 level and erector spinae muscle, study drug will be injected in the fascial planes between transverse process of T10 vertebrae and erector spinae muscle. As per randomization, Patients in group-A will receive inj. levobupivacaine 0.25% 30ml (max dose 2mg/kg (IBW)) with injection dexamethasone (0.1mg/kg) as per ideal body weight (IBW) and in group-B patients will receive inj. levobupivacaine 0.25% 30ml (max dose 2mg/kg(IBW)) with injection dexmedetomidine 0.5mcg/kg in erector spinae block. Block will be performed either by anesthesia consultants or by 3rd year residents under supervision of anesthesia consultants.
General anesthesia will be started by preoxygenating patient with 100% oxygen via closed circuit manual ventilation. Premedication’s will be given starting with Inj. glycopyrrolate (0.004mg/kg), inj. fentanyl (0.5- 2mcg/kg), in.j midazolam (0.1- 0.2mg/kg), inj. lignocaine (0.5-1mg/kg ) for blunting stress responses during intubation .Patient will be induced using Inj. propofol( 2mg/kg ) followed by check ventilation .Adequate muscle relaxation will be achieved with inj. succinylcholine 1mg/kg or inj. atracurium 0.5mg/kg or inj. vecuronium 1mg/kg . Patient will be intubated using conventional laryngoscope, long acting muscle relaxation will be achieved with inj. atracurium 0.5mg/kg or inj. vecuronium 1mg/kg. Patient is maintained on closed circuit controlled mechanical ventilation on oxygen +air +sevoflurane/Desflurane with bolus doses of muscle relaxant. Constant monitoring of hemodynamic parameters (Heart rate, blood pressure) and blood loss monitoring will be done . Postoperatively Post-operatively, the pain will be monitored using the visual analogue score (VAS) at rest and on deep breathing at times zero (H0), 1 hour (H1), 2 hours (H2), 4 hours (H4), 6 hours (H6), 12 hours (H12), 18 hours (H18) and 24hours(H24). If VAS ≥4 , rescue analgesia using Inj. tramadol 0.5mg/kg will be given. In case of persistent pain Inj. Tramadol 0.5mg/kg or inj. fentanyl 0.5mcg/kg will be given 6 hourly . Postoperatively patient’s overall recovery will be assessed using Quality of Recovery 40 questionnaire (QoR 40) .This questionnaire is available in public domain and it is been translated and back-translated into vernacular language by two different linguists. Any intraoperative or post operative side effects (like nausea, vomiting, giddiness ,Tingling numbness , hypotension, bradycardia) will be noted. Postoperatively side effects will be managed by the following: 1. Vomiting will be managed by giving inj ondansetron 0.1mg/kg 2. Hypotension is systolic blood pressure <20% of the baseline , Intravenous fluids like ringers lactate will be given, in case of persistent hypotension Inj mephentermine 0.1mg/kg will be administred. 3. Bradycardia is heart rate <20% of baseline ,Inj atropine 0.6mg will be given. 4. Tingling and numbness are transient effects and it will be observed for the same
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •1.Patients undergoing Renalsurgeries under general anaesthesia.
- •2.Aged 18 to 60 years 3.American Society of Anesthesiologists Physical Status grade I-III.
排除标准
- •Patient refusal.
- •patient with ASA IV and V.
结局指标
主要结局
To compare the postoperative analgesia in dexmedetomidine and dexamethasone group.
时间窗: immediate post-op 0 hour, 1 hour (H1), 2 hours (H2), 4 hours (H4), 6 hours (H6), 12 hours (H12), 18 hours (H18) and | 24hours(H24).
次要结局
- Assess and compare the time for 1st rescue analgesia(Assess and compare the occurrence of hemodynamic changes in both the groups)
研究者
Dr.Bhumika Pathak
Pramukh swami medical college
