Comparison of Haemodynamic changes between two types of surgery for GB Stone, laparoscopic cholecystectomy and open cholecystectomy.
- Conditions
- ASA Status 1 & 2
- Registration Number
- CTRI/2017/12/010789
- Lead Sponsor
- Indira Gandhi Institute of Medical Sciences
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 60
- Age group- 18 to 60 years 2).
- patient of either sex.
- ASA grade 1 & 2.
- Patient undergoing laproscopic and open cholecystectomy.
- Patient refusal 2).
- ASA grade 3 & 4 3).
- Any history of cardiopulmonary, Renal and neurological disorder.
- Morbid obesity 5).
- Pregnant females.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Heart Rate, SBP, DBP, MAP, Spo2, EtCo2 Before Surgery, And than every 10 min till completion of surgery
- Secondary Outcome Measures
Name Time Method Any adverse outcome Any time intraoperatively
Trial Locations
- Locations (1)
Indira Gandhi Institute of Medical Sciences
🇮🇳Patna, BIHAR, India
Indira Gandhi Institute of Medical Sciences🇮🇳Patna, BIHAR, IndiaDr Rajesh Kumar JhaPrincipal investigator9122481949rajeshjha93@gmail.com