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临床试验/CTRI/2025/09/095391
CTRI/2025/09/095391尚未招募不适用

Evaluation of the effects of positive end-expiratory pressure of 12 and 15 on intracranial pressure and dynamic lung compliance in obese patients undergoing laparoscopic cholecystectomy under low flow anaesthesia: A randomized controlled trial.

MAMC and Lok Nayak and Associated Hospitals1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
1) Intracranial pressure (as measured using Optic Nerve Sheath Diameter) at various defined time points (T0 to T5).

研究概览

简要总结

Laparoscopic cholecystectomy, the minimally invasive removal of the gallbladder, has become  the standard treatment for gallstone disease due to benefits like reduced postoperative pain and  shorter recovery times. However, the creation of pneumoperitoneum—insufflation of carbon  dioxide into the abdominal cavity leads to increased intra-abdominal pressure, which  may subsequently elevate intracranial pressure (ICP) and increase the risk of lung atelectasis.  These changes may be aggravated in obese patients. With our study, we aim to evaluate the positive end expiratory pressure (PEEP) which can be freely applied without causing a significant rise in intracranial pressure and its effects on dynamic lung compliance and hemodynamic parameters. Obese patients aged 18-65 years belonging to ASA physical status 1-2 undergoing general anaesthesia for elective laparoscopic cholecystectomy will be included and patients having Pre-existing neurological conditions affecting ICP, severe respiratory, hepatic, cardiovascular or renal dysfunction , previous history of upper abdominal surgery , pregnant women, acute or chronic eye disease, history of intake of medications affecting ICP will be excluded. Routine PAC will be done and a standard anaesthetic procedure will be followed while applying a PEEP of 12 cm H2O in one group and a PEEP of 15 cm H2O will be applied in the other. Ultrasonography will be used to measure the optic nerve sheath diameter and values of dynamic lung compliance and hemodynamic parameters will be noted from the anaesthesia workstation at predetermined time points. Statistical analysis will be performed by using the SPSS software 25 version and a p-value of <0.05 will be considered statistically significant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Undergoing general anaesthesia for elective laparoscopic cholecystectomy 2) American society of Anaesthesiologists physical status 1-2 3) BMI: 25-40kg/m2.

排除标准

  • • Pre-existing neurological conditions affecting ICP.
  • • Severe respiratory, hepatic, cardiovascular or renal dysfunction.
  • • Previous history of upper abdominal surgery.
  • • Pregnant women.
  • • Acute or chronic eye disease.
  • • History of intake of medications affecting ICP.

结局指标

主要结局

1) Intracranial pressure (as measured using Optic Nerve Sheath Diameter) at various defined time points (T0 to T5).

时间窗: T0: Baseline values before induction of anaesthesia (in supine position) | T1: 5 minutes after securing of airway and initiation of mechanical ventilation (in supine position) | T2: 10 minutes after pneumoperitoneum (in reverse Trendelenburg position) | T3: 10 minutes after application of PEEP as per group allocation. | T4: 5 minutes after desufflation (in supine position, anaesthetised; before awakening) | T5: 5 minutes after removal of airway device (in supine position)

2) Mean dynamic lung compliance at various defined time points (T1 to T4).

时间窗: T0: Baseline values before induction of anaesthesia (in supine position) | T1: 5 minutes after securing of airway and initiation of mechanical ventilation (in supine position) | T2: 10 minutes after pneumoperitoneum (in reverse Trendelenburg position) | T3: 10 minutes after application of PEEP as per group allocation. | T4: 5 minutes after desufflation (in supine position, anaesthetised; before awakening) | T5: 5 minutes after removal of airway device (in supine position)

次要结局

  • Hemodynamic parameters (mean arterial pressure, heart rate, blood oxygen saturation) every 5 minutes from induction till 20 minutes after PEEP application.(0 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes from induction.)

研究者

发起方
MAMC and Lok Nayak and Associated Hospitals
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR SHUBHAM SANANTA SAHOO

Maulana Azad Medical College

研究点 (1)

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