To evaluate the effect of melatonin premedication on Bispectral Index guided sevoflurane consumption in pediatric surgery: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To assess the effect of melatonin premedication on total sevoflurane consumption.
研究概览
简要总结
This study explores the use of melatonin as a premedication in pediatric patients undergoing general anesthesia, aiming to assess its impact on the consumption of inhalational sevoflurane. General anesthesia induces a coma-like state, and while effective, its agents come with inherent side effects. Various drugs, including melatonin, have been considered as adjuncts to minimize the required dosage of these agents. Melatonin, a hormone secreted by the pineal gland, has demonstrated anesthetic and antinociceptive properties. Despite its potential benefits, no prior research has systematically investigated the impact of melatonin premedication on sevoflurane consumption in pediatric patients.
The current study addresses this gap by evaluating the effects of melatonin premedication on total sevoflurane consumption, utilizing bispectral index (BIS) to measure the depth of anesthesia and ensure consistent appropriateness throughout the procedure. By bridging this research gap, the study aims to contribute to the advancement of pediatric anesthesiology and enhance the overall quality of care for young patients undergoing surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologists grade I or II paediatric patients (aged from 2 to 8 years) undergoing elective surgical procedure under general anaesthesia (Duration of procedure ranging from 30 minutes to 2 hours).
排除标准
- •Unwillingness to participation.
- •Paediatric patients undergoing elective surgical procedure under general anaesthesia from department of Cardiothoracic and Neurosurgery.
- •Patients with known comorbidities (renal or hepatic derangement, Asthma, TB, etc).
- •Allergy to Study drugs or Honey.
- •History of epileptic seizures, psychoactive medications, neurological disorders, or trauma.
结局指标
主要结局
To assess the effect of melatonin premedication on total sevoflurane consumption.
时间窗: 0 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes and 120 minutes after induction of anaesthesia.
Inhaled sevoflurane requirement (volume%) will be measured to maintain BIS readings between 40 to 50 using Dion method.
时间窗: 0 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes and 120 minutes after induction of anaesthesia.
次要结局
- To assess the effect on sedation scores (Ramsay Sedation Scale).(0 minutes, 30 minutes, 60 minutes after premedication and at induction of anaesthesia.)
- To assess the effect on anxiety scores (Modified yale preoperative Anxiety Scale).(0 minutes, 30 minutes, 60 minutes after premedication and at induction of anaesthesia.)
- To assess the effect on Pain scores (FLACC Scale) during post operative period.(0 minute, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, 18 hours, 24 hours in post operative period.)
- To assess the Duration of first analgesic requirement in post operative period.
- To assess the effect on Total analgesic requirement during post operative period. (Injection Fentanyl 0.5 mcg per kg IV).(Till 24 hours in post operative period.)
研究者
Pulkit Johar
AIIMS Rishikesh