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CTRI Number  CTRI/2024/03/064883 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 27/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   To know better ventilation mode in laparoscopic assisted vaginal hysterectomy  
Scientific Title of Study   An observational study to compare hemodynamic changes and gas exchange in volume controlled vs pressured controlled ventilation in patients undergoing laparoscopic assisted vaginal hysterectomy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaibhavi Hajariwala  
Designation  Professor in department of anesthesiology  
Affiliation  Pramukh Swami medical college Karamsad Anand  
Address  Pramukh Swami medical college karamsad Anand, department of anesthesiology, surgical operation theatre complex
Pramukh Swami medical college karamsad Anand, department of anesthesiology, surgical operation theatre complex
Anand
GUJARAT
388325
India 
Phone  9909977446  
Fax    
Email  vaibhavih@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vaibhavi Hajariwala  
Designation  Professor in department of anesthesiology  
Affiliation  Pramukh Swami medical college Karamsad Anand  
Address  Pramukh Swami medical college karamsad Anand, department of anesthesiology, surgical operation theatre complex
Pramukh Swami medical college karamsad Anand, department of anesthesiology, surgical operation theatre complex
Anand
GUJARAT
388325
India 
Phone  9909977446  
Fax    
Email  vaibhavih@charutarhealth.org  
 
Details of Contact Person
Public Query
 
Name  Dhruvika Rameshbhai Tilak 
Designation  Anesthesiology resident doctor 
Affiliation  Pramukh Swami medical college karamsad Anand  
Address  Pramukh Swami medical college karamsad Anand, department of anesthesiology, surgical operation theatre complex
G-82 SHREE JI TOWNSHIP SOCIETY BEHIND VRAJBHOOMI, DABHOI WAGHODIYA RING ROAD, Vadodara
Vadodara
GUJARAT
388325
India 
Phone  07359471374  
Fax    
Email  tilakdhruvika@gmail.com  
 
Source of Monetary or Material Support  
Shree Krishna hospital,karamsad, distric- Anand, Gujarat state  
 
Primary Sponsor  
Name  Shree Krishna hospital  
Address  Shree Krishna hospital karamsad Anand  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dhruvika Rameshbhai Tilak   Pramukh Swami medical college karamsad Anand  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dhruvika Rameshbhai Tilak   Shree Krishna hospital karamsad   Pramukh Swami medical college karamsad department of anesthesiology, surgical operation theatre complex of Shree Krishna hospital
Anand
GUJARAT 
07359471374

tilakdhruvika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
H M PATEL CENTRE FOR MEDICAL CARE AND EDUCATION   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  Patients with ASA(American society of Anaesthesia) 1 2 3 Physical status Women of age 18-75 years
patients undergoing elective Laparoscopic assisted vaginal hysterectomy 
 
ExclusionCriteria 
Details  Laparoscopic procedure turning into laparotomy
Severe systematic diseases and uncontrollable comorbidities with ASA (American society of anesthesiology) classification IV and V
Perioperative hemodynamic stability
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare hemodynamic stability and gas exchange in volume controlled vs pressure controlled ventilation mode in laparoscopic assisted vaginal hysterectomy   Vitals, respiratory parameters and arterial blood gas analysis will be measured after giving general anaesthesia to patient as baseline and at the end of surgery after reversing the patients again arterial blood gas analysis will be done to compare with baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Among volume controlled vs pressure controlled ventilation to find out better more of ventilation for laparoscopic assisted vaginal hysterectomy under general anaesthesia   Observational study will be carried out till 31st July after which data of all the patients about vitals respiratory parameters & arterial blood gas analysis will be collected & comparison between two groups will be carried out  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   07/04/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   After obtaining institutional ethical committee approval, obtaining patient’s informed and written consent
patients of ASA I, II, III who will be undergoing Laparoscopic assisted vaginal hysterectomy under general
anaesthesia will be recruited to participate in this prospective observational study.
After the patient arrived in operating room and applying monitors like pulse oximetry, electrocardiogram, non
invasive blood pressure monitoring, manual blood pressure monitoring, end tidal carbon dioxide monitoring all
the patients will be premedicated by 0.02 mg/kg Midazolam, 0.2mg Glycopyrolate, inj. 2% lignocaine prior to
induction. Adequate pain relief will be given by fentanyl 1mcg/kg. Induction will be carried out using Propofol 2
mg/kg, and injection succinyl choline 1mg/kg. All patients will be intubated by using endotracheal tube and
conventional laryngoscope. Patients will be put on mechanical ventilation after intubating under general
anaesthesia. Patient will be maintained on Sevoflurane at 2 minimum alveolar concentration ( fresh gas flow
2lit/min) and additional intermediate acting muscle relaxant vecuronium will be given at loading dose of
0.1mg/kg and at maintenance dose of 0.02 mg/kg. Neuromuscular blocking activity will be monitored using
Train of four, and intermediate muscle relaxant will be given only after observing 2 twitches. All the patients will be given 7ml/hour/kg Ringer lactate solution intraoperatively. Patients will be kept warm by using heated
conductive system to keep body temperature above 36 degree celcius.
All the cases for laparoscopic assisted vaginal hysterectomy will be of benign condition. The operating table will
be set to 30% Trendelenburg position and intra abdominal pressure set to 10-12 mmHg using automated
endoflatter.
Mechanical ventilator settings will be as follows- Female patients undergoing laparoscopic assisted vaginal
hysterectomy will be divided in two groups. The patients in volume controlled group will be mechanically
ventilated using volume controlled mode throughout surgery, while patients in another group will be ventilated
on volume- controlled mode initially and will be switch to pressure- controlled mode after 15 minutes of
creation of pneumoperitoneum using tidal volume 4 -7ml/kg, airway pressure will set to provide tidal volume
of 4-7 ml/kg not exceeding 35 cm H2O, inspiratory : expiratory ratio 1:2, positive end-expiratory pressure-5 cm
of H2O, initial respiratory rate 12 will be set and will be adjusted to maintain target end-tidal CO2 36 +/- 2 for
both group. Hemodynamic variables will detected by heart rate, systolic and diastolic blood pressure, mean
arterial pressure, end tidal carbon dioxide. Gas exchange parameters will be monitored by Ph, PaO2, PaCO2,
SaO2 after drawing and analysing Arterial blood sample. ventilatory parameters will be monitored by tidal
volume, peak and mean airway pressures following induction (T0), and after peritoneal insufflation at (T1)- 5
minute after pneumoperitoneum, (T2)- 10 minute after pneumoperitoneum, (T3)- 15 minutes after
pneumoperitoneum. At 15 minutes after creating pneumoperitoneum arterial blood gas sample will be
withdrawn and will be analysed immediately with blood gas analyser available at Shree Krishna hospital
laboratory.
Post operatively immediately after reversing and extubation arterial blood gas sample will be withdrawn from
patients of both group for comparison between both group of patients who received volume- controlled vs
pressure-controlled ventilation intraoperatively.
 
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