Effect of Hyperventilation Prior to CO2 Insufflation in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Mean Arterial Pressure
研究概览
简要总结
Laparoscopic surgery is nowadays a routinely performed procedure worldwide, replacing many types of open surgeries. The most commonly used gas for insufflation is carbon dioxide.
Absorption of carbon dioxide (CO2) from the peritoneal cavity is the potential mechanism for hypercapnia and a rise in the end-tidal carbon dioxide (EtCO2). Mild hypercarbia causes sympathetic stimulation which results in a fivefold increase in arginine vasopressin (AVP), tachycardia, increased systemic vascular resistance, systemic arterial pressure, central venous pressure and cardiac output.
Severe hypercarbia exerts a negative inotropic effect on the heart and reduces left ventricular function.
Hemodynamic alterations occur only when the PaCO2 is increased by 30 per cent above the normal levels.
We are conducting this research with research question : Are there any significant changes in heart rate, systolic and diastolic pressure and mean arterial pressure due to CO2 insufflation during laproscopic surgery?
If YES, then is this change affected by using hyperventilation.
All the study patients will undergo a comprehensive pre-operative evaluation .
The patients will be randomly divided into two groups using computer generated table and allotted into either of the two groups of 15 each.
Group A: the patients will be ventilated with a tidal volume (TV) of about 8 mL.kg-1 and respiratory rate (R.R) will be adjusted to maintain an end-tidal CO2 (ETCO2) of 35-40mm of Hg throughout the procedure, starting from 15 min prior to insuffalation.
Group B: the patients’ will be ventilated with a TV of 8 mL.kg-1 with the adjustment of the R.R to maintain an ETCO2 of 30-35mm Hg, throughout the procedure, starting from 15 min prior to insuffalation.
Intraabdominal Pressure will be kept between 10-12 mmHg in both the groups.
MAP, heart rate, and SpO2 will be measured at baseline and at Induction and then every 5 min till completion of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients belonging to ASA physical status I & II undergoing elective laparoscopic cholecystectomy.
排除标准
- •Patient Refusal Pregnancy Obesity Smokers.
结局指标
主要结局
Mean Arterial Pressure
时间窗: at baseline and Induction and then every 5 min till completion of surgery.
次要结局
- Heart Rate and SPO2(at baseline and Induction and then every 5 min till completion of surgery.)
研究者
Dr Shuchi Nigam
Uttar Pradesh University of Medical Sciences, Saifai,Etawah