Comparison on the Effectiveness of Intravenous Magnesium Sulphate and Intravenous Dexmedetomidine in Reducing Emergence Agitation in Adults Undergoing Otorhinolaryngology Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Proportion of Patients Experiencing Emergence Agitation
研究概览
简要总结
The goal of this clinical trial is to learn whether intravenous magnesium sulphate can reduce emergence agitation as effectively as intravenous dexmedetomidine in adult patients undergoing otorhinolaryngology surgery under general anesthesia.
The main questions it aims to answer are:
- Is intravenous magnesium sulphate non-inferior to intravenous - dexmedetomidine in reducing the proportion of emergence agitation (defined as Richmond Agitation-Sedation Scale [RASS] ≥2)? Are there differences between the two drugs in terms of hemodynamic stability, severity, onset and duration of emergence agitation, and recovery profile? Researchers will compare continuous intravenous magnesium sulphate infusion (20 mg/kg/hour) with continuous intravenous dexmedetomidine infusion (0.5 µg/kg/hour) to see if magnesium sulphate provides similar protection against emergence agitation with fewer hemodynamic side effects.
Participants will:
- Be randomized to receive either magnesium sulphate or dexmedetomidine infusion from induction of anesthesia until the end of surgery.
- Undergo standardized general anesthesia with sevoflurane, fentanyl, and rocuronium.
- Be assessed for emergence agitation using the Richmond Agitation-Sedation Scale (RASS) after discontinuation of anesthetic agents.
- Have intraoperative heart rate, mean arterial pressure, anesthetic consumption, and vasoactive drug use recorded.
- Be evaluated postoperatively for pain, opioid requirement, and extubation time.
详细描述
This multicenter, double-blinded, randomized controlled trial was designed to evaluate two intraoperative pharmacologic strategies used during general anesthesia for adult otorhinolaryngologic surgery.
The study is based on differing pharmacodynamic mechanisms: dexmedetomidine provides central sympatholysis via selective α2-adrenergic receptor activation, while magnesium sulphate modulates neuronal excitability primarily through NMDA receptor antagonism and calcium channel blockade. Both agents are administered as continuous infusions during surgery without a loading dose to allow steady-state effects and minimize abrupt hemodynamic changes.
Randomization is performed using a computer-generated sequence with allocation concealment. Study medications are prepared by independent pharmacy personnel in identical syringes to maintain blinding of anesthesia providers, patients, and investigators. Perioperative anesthetic management is standardized across sites to reduce variability in clinical practice.
Physiologic parameters are recorded at predefined perioperative intervals using structured case report forms. Data are analyzed using appropriate statistical methods based on distribution characteristics, including longitudinal modeling to account for repeated intra-subject measurements. A two-sided significance threshold is prespecified for all analyses.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-70 years
- •ASA physical status I or II
- •Undergoing elective otorhinolaryngology surgery under general anesthesia
- •Willing to participate and provide informed consent
排除标准
- •Pregnant patients
- •Severe cognitive impairment
- •Known allergy to study drugs
- •Contraindications to study drugs (atrioventricular block, sinoatrial node dysfunction, renal failure)
- •Neuromuscular disorders
- •Regular use of beta-blockers or clonidine
- •Not extubated in the operating room or post-anesthesia care unit after procedure
- •Body mass index (BMI) ≥ 40
研究组 & 干预措施
Magnesium Sulphate
Participants receive continuous intravenous magnesium sulphate infusion administered intraoperatively from induction of anesthesia until the end of surgery as part of standardized general anesthesia management.
干预措施: Magnesium sulphate (Drug)
Dexmedetomidine
Participants receive continuous intravenous dexmedetomidine infusion administered intraoperatively from induction of anesthesia until the end of surgery as part of standardized general anesthesia management.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Proportion of Patients Experiencing Emergence Agitation
时间窗: From discontinuation of anesthetic agents until discharge from the post-anesthesia care unit (PACU), up to approximately 1 hour post-extubation.
Emergence agitation defined as Richmond Agitation-Sedation Scale (RASS) score ≥ 2 during the early recovery phase following discontinuation of anesthetic agents. Assessment performed by trained blinded assessors in the operating room and post-anesthesia care unit.
次要结局
- Severity of Emergence Agitation(From discontinuation of anesthetic agents until discharge from PACU, up to approximately 1 hour post-extubation.)
- Onset of Emergence Agitation(uring the early recovery period, up to approximately 1 hour post-extubation.)
- Duration of Emergence Agitation(During the early recovery period, up to approximately 1 hour post-extubation.)
- Mean Arterial Pressure(From baseline (pre-induction) until 1 hour postoperatively.)
- Heart Rate(From baseline (pre-induction) until 1 hour postoperatively.)
- Postoperative Pain(During PACU stay (up to approximately 1 hour post-extubation).)
- Extubation Time(From cessation of anesthetic agents until extubation during the immediate recovery phase, up to approximately 1 hour post-extubation.)
研究者
Riyadh Firdaus
Consultant Neuroanesthesiologist
Indonesia University