| CTRI Number |
CTRI/2017/12/010789 [Registered on: 06/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Haemodynamic changes between two types of surgery for GB Stone, laparoscopic cholecystectomy and open cholecystectomy. |
|
Scientific Title of Study
|
Comparative evaluation of haemodynamic and capnographic changes in laparoscopic cholecystectomy and open cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Kumar Jha |
| Designation |
M.D. student |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical Care Medicine
Indira Gandhi Institute of Medical Sciences,
Sheikhpura
Patna
BIHAR
800014
India |
| Phone |
9122481949 |
| Fax |
|
| Email |
rajeshjha93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar Verma |
| Designation |
Additional Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical Care Medicine
Indira Gandhi Institute of Medical Sciences,
Sheikhpura
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Kumar Verma |
| Designation |
Additional Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical Care Medicine
Indira Gandhi Institute of Medical Sciences,
Sheikhpura
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Patna |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences |
| Address |
Sheikhpura, Patna-14,Bihar |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Kumar Jha |
Indira Gandhi Institute of Medical Sciences |
GIS OT no 3, Main OT complex
Patna
BIHAR |
9122481949
rajeshjha93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA Status 1 & 2, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1). Age group- 18 to 60 years
2). patient of either sex.
3). ASA grade 1 & 2.
4). Patient undergoing laproscopic and open cholecystectomy. |
|
| ExclusionCriteria |
| Details |
1). Patient refusal
2). ASA grade 3 & 4
3). Any history of cardiopulmonary, Renal and neurological disorder.
4). Morbid obesity
5). Pregnant females |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate, SBP, DBP, MAP, Spo2, EtCo2 |
Before Surgery, And than every 10 min till completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse outcome |
Any time intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1. Black TE. Anaesthesia for laparoscopic-assisted surgery. In: Healy EJ, Cohen PJ, editors. A practice of anaesthesia. 6th ed. Manchester: Arnold Press. 2000; p.1391-96.
2. Jean L. Anesthesia for laparoscopic surgery. In: Miller RD, editor. Anesthesia. 5th ed. New York: Churchill Livingstone, 2003; p .2003-23.
3. Tripathi DC, Shah KS, Dubey SR, Doshi SM, Raval PV. Hemodynamic stress response during laparoscopic cholecystectomy: Effect of two different doses of intravenous clonidine premedication. J Anaesthesiol Clin pharmacol; 2011; 27:475-80
4. Sammour T, Mittal A, Lovedy BP, et al. Systemic review of oxidative stress associated with pneumoperitoneum. Br J Surg. 2012 ; 96:836-850.
5. Joris JL, Noirot DP Legrand MJ et al: Hemodynamic changes during laparoscopic cholecystectomy. Anaesth Analg 1993; 76:1067.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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/minute and 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 |