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临床试验/CTRI/2024/05/067865
CTRI/2024/05/067865尚未招募4 期

Comparison of quality of recovery with opioid-based versus opioid free anaesthesia in pediatric patients undergoing brain tumor surgeries A Prospective randomized control trial

All India Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月3日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
To compare the difference between quality of recovery score (Pediatric QoR 15 score) using opioid free anaesthesia and opioid based anaesthesia in the paediatric patients undergoing brain tumor.

研究概览

简要总结

Group A patients will receive inj. fentanyl 2mcg/kg and Group B patients will receive inj. dexmedetomidine 0.5 mcg/kg/hr over 10 minutes. On successful bag mask ventilation, inj atracurium 0.5mg/kg will be given. The airway will be secured with appropriate size endotracheal tube. Scalp block will be given with 0.5% ropivacaine in group B according to surgical incision site (1ml of 0.5% ropivacaine will be given at each of the 6 nerves i.e. supratrochlear nerve, supraorbital nerve, auriculotemporal nerve, zygomatic temporal nerve, greater and lesser occipital nerve). Anaesthesia will be maintained with sevoflurane + O2 and air (50-50%) in both the groups. In group A, continuous fentanyl infusion (1 µg/kg/hr) and in group B, continuous dexmedetomidine infusion (0.4 mcg/kg/hr) will be started immediately after induction. In Group A, fentanyl infusion and in Group B, dexmedetomidine infusion will be stopped 15 min before the expected completion of surgery. Inj. Paracetamol (10 mg/kg) will be given in both the groups 10 min before the expected completion of surgery. After returning of spontaneous respiration and reversal of residual neuromuscular blockade using neostigmine (0.05 mg/kg) and glycopyrrolate  (0.01mg/kg), patients will be extubated. The duration of anaesthesia and surgery will be noted in both the groups.. The patients will be monitored in post anaesthetic care unit (PACU) and discharged from PACU after achievement of modified Aldrete score. The time of PACU discharge will be noted and compared between the study groups.Quality of recovery will be assessed by Paediatrics QOR 15 score. QOR will be assessed at the baseline and at 24 hrs in both the groups and difference between QOR at the baseline and at 24 hrs will be compared between both the groups. The anaesthetist assessing the QOR 15 score will be different from the anaesthetist involved in the induction of anaesthesia and application of scalp block.Postoperatively, Pain score will be assessed using the numerical 0–10 visual analogue scale (VAS). The pain will be classified as mild pain (score 0–3), moderate (score 4–6) to severe (score 7–10) pain. Assessment of pain by scale will be on arrival to PACU and postoperatively at 30 min, 2 h, 6 h, 12 hand 24 h .In the PACU, the necessity for rescue analgesia will be decided by the pain score. Rescue medication will be administered when patients will have score of ≥4 on at least 2 occasions or will show obvious signs of pain. Intravenous diclofenac ( in a dose of 1.5 mg/kg ) will be used as a rescue analgesic for all the patients. The number of doses of rescue medication required and the time of administration of first dose rescue medication will also be noted. In the postoperative period, patients will also be monitored for adverse effects, including respiratory depression, vomiting. Respiratory depression will be defined as a decrease in oxygen saturation <93%, requiring oxygen by face mask.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
7.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • All the paediatric patients with age 7-18 years undergoing an elective brain tumor surgeries under general anaesthesia.

排除标准

  • Patients with associated congenital cardiac anomalies 2.Patients with prior hypersensitivity to the drug
  • Patients requiring postoperative mechanical ventilation 4.Patients with hypovolemic, neurogenic or septic shock.

结局指标

主要结局

To compare the difference between quality of recovery score (Pediatric QoR 15 score) using opioid free anaesthesia and opioid based anaesthesia in the paediatric patients undergoing brain tumor.

时间窗: At Baseline and 24hrs After Surgery

次要结局

  • Postoperative Pain(Time of first Rescue Analgesia)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Divya Patel

Department of Anaesthesiology and Critical Care,AIIMS,Jodhpur

研究点 (1)

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