Incidence of peri-operative respiratory adverse events with target-controlled infusion of propofol anesthesia in pediatric adenoidectomy and tonsillectomy surgeries - An observational study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- 1. To record the occurrence of perioperative respiratory adverse events which include laryngospasm, bronchospasm, breath holding, coughing, desaturation
研究概览
简要总结
After institutional ethical committee clearance, patients will be selected for the study based on inclusion and exclusion criteria, and informed written consent/ assent will be obtained from the parents/ child during the pre-anaesthesia check-up.
Patients will be assessed before the procedure in pre-anaesthetic check-up (PAC) visit and thorough history taking and examination will be done. Standard pre-operative nil per oral advise will be given.
In the OT, a standard inhalational induction of anaesthesia, (50% oxygen + 50% nitrous oxide and 2-8 % sevoflurane in increments) will be performed. ASA standard monitors (Electrocardiography, Pulse oximetry, Non-invasive blood pressure) and processed EEG monitor (to assess depth of anaesthesia) will be connected and baseline values recorded. IV cannula will be secured under inhalational anaesthesia. Nitrous oxide and sevoflurane will be turned off once iv cannula is secured. Inj Fentanyl 2 mcg/kg given and TIVA-TCI Eleveld model of propofol will be started at effect site concentration (Ce) 1 mcg/mL and titrated at increments of 0.5 mcg/mL to target BIS value between 40-60.
inj atracurium 0.5 mg/kg IV will be given and after 4 min endotracheal intubation will be performed with appropriate sized endotracheal tube. Inj.Morphine IV at dose of 0.05 mg /kg bolus will be administered before incision and boluses of 0.025 mg/kg will be repeated if required to a maximum dose of 0.1 mg/kg. All patients will receive Inj.Dexamethasone 0.2 mg/kg, Inj.Paracetamol 15 mg/kg, Ibugesic 5 mg/kg for analgesia.
ECG, HR, MAP, Saturation (SpO2), end tidal co2 will be monitored continuously throughout the surgery and anaesthesia as per the standard intraoperative monitoring.
At the end of surgery, Inj.Ondansetron 0.1mg/kg will be given for postoperative nausea and vomiting prophylaxis. Then TIVA –TCI will be discontinued (i.e effect site concentration (Ce) set to 0 mcg/ml) and patient will be extubated once extubation criteria is met.
Values noted:
· Ce value at maintenance of anaesthesia (mcg/ml)
· Ce at return of responsiveness (RoR) (RoR is defined as awakening to verbal command or slight tapping).
· the time taken for RoR after discontinuing propofol TCI.
· the total propofol consumption (mg/kg/hr)
· the total opioid consumption.
The patient will be shifted to post anaesthesia care unit and monitored for 60 minutes. The occurrence of following events will be documented:
· Respiratory adverse events (laryngospasm, bronchospasm, cough, breath holding, airway obstruction, desaturation < 92%)
· Sedation score (PASS – Paediatric Analog Sedation Score),
· Emergence delirium score (PAED scale)
· Postoperative nausea and vomiting (PONV)
· Pain score (FACES scale for 4-7 years old and NRS scale for 7-16 years)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 4.00 Year(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •All children undergoing elective Adenoidectomy or Tonsillectomy or Adeno tonsillectomy surgeries from 4 to 16 years of age belonging to American Society of Anaesthesiologist Physical Status (ASA PS) 1 and 2.
排除标准
- •lack of parental consent for the child’s participation 2)children with hypersensitivity to the drugs used in study 3)children with congenital anomalies, mitochondrial myopathy, cerebral palsy, musculo-skeletal disorders or any moderate to severe systemic illness.
结局指标
主要结局
1. To record the occurrence of perioperative respiratory adverse events which include laryngospasm, bronchospasm, breath holding, coughing, desaturation
时间窗: 1. at induction of Anesthesia | 2. at maintenance of Anesthesia | 3. at extubation | 4. in post anesthesia care unit (for 1 hour)
次要结局
- 1.To record the concentration of propofol at effect site (Ce) using Eleveld TCI pharmacokinetic model of propofol for(.maintenance of anaesthesia under BIS guidance)
研究者
SINDHUJA T
SAKRA WORLD HOSPITAL
