“Comparison of Opioid-Sparing Versus Conventional Opioid-Based Anaesthetic Technique on Recovery Characteristics in Paediatric Patients Undergoing Cleft Palate Repair – A Randomised Controlled Trial.”
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The time to first successful oral intake [in mins]
研究概览
简要总结
This randomized, double-blind controlled trial aims to compare an opioid-sparing anaesthetic technique with a conventional opioid-based technique in children aged 6 months to 6 years undergoing cleft palate repair. Opioid-based anaesthesia may delay recovery due to respiratory depression, sedation, nausea, and emergence agitation. Opioid-sparing strategies using dexmedetomidine, ketamine, lignocaine, and regional nerve blocks may improve recovery and reduce opioid-related side effects.
Eligible patients will be randomized into two groups. The opioid-based group will receive fentanyl-based anaesthesia, while the opioid-sparing group will receive dexmedetomidine, Ketofoll and lignocaine, along with ultrasound-guided suprazygomatic maxillary nerve block. All patients will undergo standard general anaesthesia and postoperative monitoring.
The primary outcome is the time to first successful oral intake after arrival in the post-anaesthesia care unit (PACU). Secondary outcomes include intraoperative haemodynamic stability, time to extubation, emergence agitation (WATCHA score), postoperative vomiting, FLACC pain scores, and time first to rescue analgesia.
A total of 64 participants (32 per group) will be enrolled. The study will help determine whether opioid-sparing anaesthesia leads to faster recovery and fewer postoperative complications in paediatric cleft palate surgery.
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
- 6.00 Month(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Physical Status I or II Age: 6 months to 6 years Sex – male and female.
- •Elective, cleft palate repair.
排除标准
- •Developmental delay or prematurity Allergy to dexmedetomidine, propofol or lignocaine.
- •Severe cardiac conduction abnormalities Baseline bradycardia [HR less than 50] Severe hypovolemia Advanced heart block Severe ventricular dysfunction.
结局指标
主要结局
The time to first successful oral intake [in mins]
时间窗: In the post op period : From the time of arrival in the post-anaesthesia care unit [PACU] or recovery area.
次要结局
- Time to Extubation [minutes](the cessation of inhalational anaesthetic agent to successful tracheal extubation (when TOF ratio more than equal to 0.9))
- WATCHA Score(post-extubation at 10 mins duration)
- Intraoperative Hemodynamic Stability [HR & BP](every 5 min intraoperatively)
- Postoperative Vomiting [POV] Episode(within the first 4–6 hours postoperatively)
- FLACC Score [Pain Assessment](be recorded at 0, 30, and 60 minutes postoperatively)
- Time to First Rescue Analgesia [minutes]:(the time from arrival in PACU to the administration of first rescue analgesic)
研究者
Dr Saurav Devale
All India Institute Of Medical Sciences