Dexmedetomidine as Adjuvant for Suprazygomatic Maxillary Nerve Block in Children's Adenotonsillectomy: a Randomized Controlled Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Opioid-free recovery
研究概览
简要总结
The goal of this clinic trial is to evaluate the impact of dexmedetomidine as an adjunct pain pain medication on opioid-free recovery in children undergoing adenotonsillectomy with Suprazygomatic maxillary nerve block (SZMB). The main questions it aims to answer are:
- Does SZMB with the local anesthetic ropivacaine and the adjuvant dexmedetomidine result in less pain
- Is dexmedetomidine associated with an improved quality of recovery at home Researchers will compare pain in participants given an SZMB with ropivacaine and an adjuvant dexmedetomidine, participants given SZMB with ropivacaine only, and a SZMB with ropivacaine and dexmedetomidine given intravenously.
Participants will:
- Be given the SZMB during the surgery.
- Be evaluated after surgery to measure their opioid consumption, pain severity, level of agitation, and level of delirium
- Complete a daily questionnaire for 7 days after surgery on the patients pain and recovery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective partial adenotonsillectomy,
- •STUBR score ≥ 3, indicating significant sleep-disordered breathing
- •Patients whose parents are fluent in French of English will be enrolled
排除标准
- •Scheduled to undergo total extracapsular adenotonsillectomy or adenoidectomy-only procedures
- •Patient requires prolonged intubation postoperatively
- •the anesthesiologist does not adhere to the standardized anesthesia protocol
- •Patients with neurological or cardiac congenital deficits, with cardiac arrhythmias (non-sinus rhythm), implanted pacemakers, on chronic therapy with drugs that have known effects on sympathetic and parasympathetic activity (antimuscarinics, beta-2 adrenergic agonists, alpha-1 adrenergic antagonists or antiarrhythmic agents, tricyclic antidepressants)
- •ASA physical status III or higher
- •Parent/legal guardians refuses to participate
- •Patients scheduled for surgery without an appointment at the Montreal Children's Hospital (MCH) Preoperative Clinic will not be enrolled in the study.
研究组 & 干预措施
Group D
Group D will receive an SMB of 0.1 ml/kg of local anesthetic ropivacaine 0.2% (max 5 ml). After the block a bolus of intravenous dexmedetomidine 0.25 mcg/kg i.v. will be given.
干预措施: Ropivacaine (Procedure)
Group RD
- Group RD will receive an SZMB of 0.1 ml/kg of a solution of local anesthetic ropivacaine 0.2% and dexmedetomidine 1 mcg/ml (max 5 ml). After the block, 0.1 ml/kg of normal saline will be administered intravenously. No dexmedetomidine i.v. will be given.
干预措施: Ropivacaine (Procedure)
Group R
Group R will receive an SZMB of 0.15 ml/kg of local anesthetic ropivacaine 0.2% (max 5 ml). After the block, 0.1 ml/kg of normal saline will be administered intravenously. No dexmedetomidine will be given.
干预措施: Ropivacaine (Procedure)
结局指标
主要结局
Opioid-free recovery
时间窗: 2 hours
Incidence of patients not requiring opioids in the PACU after surgery
次要结局
- Number of patients with postoperative Pain(2 hours)
- Number of Patients with Emergence Delirium(2 hours)
- Pain through follow-up(7 days)
- Quality of Recovery through follow-up(7 days)
研究者
Gianluca Bertolizio
Dr
McGill University Health Centre/Research Institute of the McGill University Health Centre