To study salivary cortisol as a surrogate marker of stress response in children undergoing laparoscopic surgery with low- pressure vs high-pressure pneumoperitoneum : a randomized controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary outcome measures are pre-operative and post-operative salivary cortisol levels in the two study groups.
研究概览
简要总结
Aims & Objectives: 
 
To determine the stress response in children undergoing laparoscopic surgery with low- pressure vs high-pressure pneumoperitoneum (PP).
Materials and methods: 
Study design: Prospective, randomized, single blind, observational study  
 
Study site: SGPGIMS, Lucknow 
 
Study duration: 12 months 
 
Study population 
 
Inclusion criteria:  
- Children aged 1-12 years undergoing laparoscopic surgery 
Exclusion criteria:  
-
Children with underlying adrenal pathologies e.g. adrenal tumors, congenital adrenal hyperplasia etc.  
-
Children on steroid therapy  
-
Children undergoing laparoscopic surgery for acute inflammatory conditions like appendicitis, Meckel’s diverticultis etc.  
-
Refusal of parental consent for participation in the study 
 
Description of interventions: 
Patients will be randomized to either low-pressure PP group (group I) or high-pressure PP group (group II).  
Heart rate (HR), non-invasive mean arterial blood pressure (MAP) and end tidal CO2 (EtCO2) will be measured at four points: before CO2 insufflation (T0), 20 min after insufflation (T1), before desufflation (T2), and 10 min after desufflation (T3).  
  Duration of anaesthesia and surgery, duration of hospital stay, time to resume feeding, post-operative pain and analgesia requirement will be recorded. 
 
Saliva collection and preparation 
Saliva shall be collected from each study participant pre-operatively and at 6, 12, 24, 48 and 72 hrs post-operatively. Sample will be refrigerated at 4oC within 30 minutes and then frozen at or below -20°C within 12 hours after collection.  
 
 Salivary cortisol measurement methods 
Salivary cortisol shall be measured by commercially available ELISA kits 
 
Outcome measures 
The primary outcome measures are pre-operative and post-operative salivary cortisol levels in the two study groups.  
Secondary outcome measures are HR, MAP, EtCO2 during surgery at different time points as mentioned earlier, duration of the surgery, length of hospital stay, time to resume feeds, post-operative pain and analgesia requirement. 
 
Analysis plan: 
Statistical analysis to be performed using software “Statistical package for social sciences version 23 (SPSS-23) and MedCalc.  
Key words (at least 5): pediatric; laparoscopy; stress response; salivary cortisol; pneumoperitoneum; low-pressure; high-pressure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 1-12 years undergoing laparoscopic surgery.
排除标准
- •Children with underlying adrenal pathologies e.g. adrenal tumors, congenital adrenal hyperplasia (CAH), etc.
- •Children on steroid therapy Children undergoing laparoscopic surgery for acute inflammatory conditions like appendicitis, Meckel’s diverticultis etc.
- •Refusal of parental consent for participation in the study.
结局指标
主要结局
The primary outcome measures are pre-operative and post-operative salivary cortisol levels in the two study groups.
时间窗: Pre-operatively. at 6 hours post surgery, at 12 hours post surgery, at 24 hours post surgery, at 48 hours post surgery, at 72 hours post surgery.
次要结局
- Secondary outcome measures are HR, MAP, EtCO2 during surgery at different time points as mentioned earlier, duration of the surgery, length of hospital stay, time to resume feeds, post-operative pain & analgesia requirement(HR, MAP AND EtCO2 will be recorded, before CO2 insufflation (T0), 20 min after insufflation (T1), before desufflation (T2), & 10 min after desufflation (T3))
研究者
Dr Ankur Mandelia
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow