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临床试验/CTRI/2017/12/010789
CTRI/2017/12/010789招募中不适用

Comparative evaluation of haemodynamic and capnographic changes in laparoscopic cholecystectomy and open cholecystectomy

Indira Gandhi Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年10月8日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Heart Rate, SBP, DBP, MAP, Spo2, EtCo2

研究概览

简要总结

Preanaesthetic check up will be done a day prior to surgery. Preanaesthetic evaluation will include the following assessments:

General condition of the patient.

Airway assessment  using  Mallampati  grading. A general physical examination including  height, weight and BMI

A detail systemic examination of cardiovascular, respiratory, central nervous   system or any deformity.

Following investigations will be done in all patients:

Haemoglobin estimation

Total WBC count, Differential WBC count

BT, CT, PT (INR)

Blood sugar: FBS/PPBS

Blood Urea, Serum creatinine

Liver function test

HIV-I, II and HbsAg and HCV

A standard 12 lead ECG

A screening  chest X ray ( If required)

  The procedure  will be explained to the patient and informed consent will be taken. Preparation will include an  fasting of 6 hours before the surgery, premedication  with a night before and on the morning of surgery with oral tablet lorazepam 1mg  and tab ranitidine 150 mg.

 On the day of surgery, patient will be shifted to operation theatre with 18G IV canula will be secured on non dominant hand. On operation theatre table, intravenous fluid with Ringer lactate will be started.

Non invasive Blood pressure Monitor, Pulse oxemeter and ECG leads will be connected to the patient and baseline values of Pulse rate, systolic (SBP) and diastolic(DBP) blood pressure, mean arterial pressure(MAP) and  saturated pressure of arterial oxygen (SpO2) will be recorded. Electrocardiogram (ECG) will be monitored continuously. Intravenous Fentanyl 2microgram/kg body weight will be given just before induction of anaesthesia. Anaesthesia will be induced with propofol 2mg/kg body weight of patient or sleeping dose. Neuromuscular blocking will be done with vecuronium 0.1 mg/kg body weight of patient. After adequate neuromuscular blocking trachea will be intubated with appropriate size of Endotracheal tube and Etco2 monitoring will be started. Heart rate, SBP, DBP, MAP, Etco2 and Spo2 will be recorded after intubation.

Anaesthesia will be maintained with O2, N2O, Isoflurane and intermittent bolus dose of vecuronium. Heart rate, SBP, DBP, MAP, Spo2, Etco2 and any changes in ECG will be recorded at the time of insufflation of peritoneum with Co2 in case of lap cholecystectomy and then every 10 min till the time of completion of surgery. During insufflation of peritoneum with CO2 surgeon will be asked to insufflate the peritoneum slowly i.e. flow rate of CO2 will be 1 litre/minute to 2 litre/minuteand maximum intraperitoneal pressure allowable will be 12mm of Hg. In case of open  cholecystectomy the parameters will be recorded at the time of incision and then every 10 min till completion of surgery

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age group- 18 to 60 years 2).
  • patient of either sex.
  • ASA grade 1 &
  • Patient undergoing laproscopic and open cholecystectomy.

排除标准

  • Patient refusal 2).
  • ASA grade 3 & 4 3).
  • Any history of cardiopulmonary, Renal and neurological disorder.
  • Morbid obesity 5).
  • Pregnant females.

结局指标

主要结局

Heart Rate, SBP, DBP, MAP, Spo2, EtCo2

时间窗: Before Surgery, And than every 10 min till completion of surgery

次要结局

  • Any adverse outcome(Any time intraoperatively)

研究者

申办方类型
Government medical college

研究点 (1)

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