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CTRI Number  CTRI/2024/06/068717 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two modes of ventilation in women undergoing laparoscopic surgery under General Anaesthesia  
Scientific Title of Study   Comparison of Volume controlled ventilation and Pressure controlled ventilation in patients undergoing gynaecological laparoscopic surgery under General Anaesthesia using I-gel: A randomized controlled trial 
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.Hemanth 
Designation  Post Graduate in Department of Anaesthesiology 
Affiliation  Vijayanagar Institute of Medical Sciences,Rajiv Gandhi University of Health Sciences 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences, cantonment, Ballari Bellary KARNATAKA 583104 India

Bellary
KARNATAKA
583104
India 
Phone  7975139477  
Fax    
Email  hemanthmn577@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bala Subramanya H 
Designation  Professor ,Department of Anaesthesiology 
Affiliation  Vijayanagar Institute of Medical Sciences,Rajiv Gandhi University of Health Sciences 
Address  Department of Anaesthesiology, vijayanagar Institute of Medical Sciences,cantonment,Ballari Ballari KARNATAKA 583104 India

Bellary
KARNATAKA
583104
India 
Phone  9980600724  
Fax    
Email  halsanadu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Hemanth 
Designation  Post Graduate in Department of Anaesthesiology 
Affiliation  Vijayanagar Institute of Medical Sciences,Rajiv Gandhi University of Health Sciences 
Address  Department of Anaesthesiology,Vijaynagar Institute of Medical Sciences,cantonment,Ballari Ballari KARNATAKA 583104 India

Bellary
KARNATAKA
583104
India 
Phone  7975139477  
Fax    
Email  hemanthmn577@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  vijayanagar institute of medical scienceballari 
Address  Department of Anaesthesia Vijayanagar institute of medical science, Cantonment ,Ballari, Karnataka , India 583104 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemanth  Vijayanagar Institute of Medical Sciences  Department of Anaesthesiology Major OT Complex,Cantonment,Ballari, 583104 Ballari KARNATAKA
Bellary
KARNATAKA 
7975139477

hemanthmn577@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE,VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES, BALLARI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: Z409||Encounter for prophylactic surgery, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pressure Controlled Ventilation  Pressure Controlled Ventilation following General anaesthesia with I gel insertion in Gynaecological Laparascopic Surgeries till completion of surgeries 
Intervention  Volume Controlled Ventilation  Volume Controlled Ventilation following General anaesthesia with I-gel insertion in Gynaecological Laparascopic Surgeries till completion of surgeries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1.Patients Undergoing Elective Gynaecological Laparascopic Surgeries
2.Patients in the age group of 18- 60 Years
3.Patients Belonging to ASA Physical Status 1 and 2
4.BMI Less Than and Equal to 30 
 
ExclusionCriteria 
Details  1.Any Contraindication for the use of Supraglottic Airway Devices
2.Patients Refusal for the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Peak Airway Pressure after Initiation of Pneumoperitoneum Measured at Defined Intervals  T1.1o Minutes after Induction in Supine Position
T2. After Creation of Pnemoperitoneum and achieving a stable End Tidal Carbon Dioxide Level of 35-40mm of hg for 5 Minutes
T3.15 Minutes After Pneumoperitoneum in the Trendelenburg Position
T4.10 Minutes After Pneumoperitoneum Withdrawal in Supine Position 
 
Secondary Outcome  
Outcome  TimePoints 
1.Haemodynamic Changes (SBP,DBP,MAP AND HR ) at Defined Intervals
2.Respiratory Mechanics P Mean & Dynamic Compliance in both the Groups
3.Final Ventilator settings Expiratory Tidal Volume & Respiratory Rate Required to achieve a stable EtCo2 of 35-40 mm of hg
4.Incidence of sore throat in both Groups
5.I GEL Insertion Number of attempts & success rate of insertion in both the Groups
6.Oropharyngeal Leak Pressure Measured by closing the Expiratory Valve of Closed Circuit at fixed gas flow & noting the Equilibrium Airway Pressure 
T1.10 Minutes after Induction in Supine Position
T2.After Creation of Pneumoperitoneum & achieving a stable End Tidal carbon dioxide LEVEL OF 35 -40 mm of hg for 5 minutes.
T3-15 Minutes After Pneumoperitoneum in the Trendelenburg P0sition
T4-10 Minutes After Pneumoperitoneum Withdrawal in Supine Position
 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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   Phase 4 
Date of First Enrollment (India)   01/07/2024 
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="6"
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            

All patients meeting the inclusion and exclusion criteria, will undergo detailed pre-anaesthetic evaluation, written and informed consent will be taken for study. All patients will be premedicated with inj. midazolam, 0.02 mg/ kg IV in premedication room after obtaining intravenous access. In operating room, RL is started as a maintenance IV fluid, patients are connected to multi para-monitor of Avance CS20�’ Anaesthesia workstation consisting of Electrocardiography (ECG), noninvasive blood pressure (NIBP), and pulse oximeter (SpO2). After preoxygenation, anesthesia will be induced with inj.Propofol 2 mg/kg, and inj. fentanyl 2.0 mcg/kg IV. Muscle relaxation will be facilitated with inj.vecuronium 0.1 ml/kg. Post induction capnography and neuro muscular monitoring are also done. Appropriate size I gel is inserted (Size 3 for 30-60 kg and size 4 for 50 -90 kg). Successful placement of I gel is confirmed by clinical tests (square waveform in capnogram, and bilateral equal air entry). Oro-pharyngeal leak pressure will be measured in both the groups. Mechanical ventilation will be performed using the closed circuit and anaesthesia will be maintained with sevoflurane 1-2 % in Oxygen-N2O mixture (60:40) with VCV mode of ventilation with a tidal volume (TV) of 8 ml/kg, respiratory rate (RR) of 15 bpm, Positive end expiratory pressure(PEEP) of 5 cm of H2O and I: E ratio of 1:2.

Patients will be then randomly allocated into 2 groups of 25 patients each by using computer-generated random numbers available at website Research randomizer(www.randomizer.org). Allocation concealment is done using serially numbered opaque envelope (SNOSE)technique. Mechanical ventilation is further continued as per group allocation.

Group V: Mechanical ventilation continued with VCV mode without changing the settings.

Group P: Mechanical ventilation switched over to PCV mode with an initial inspiratory pressure of 15 cm of H2O, which is titrated to achieve a TV of 8 ml/kg, other settings being kept same (RR of 15 bpm, I: E of 1:2 and PEEP of 5 cm of H2O).

Later in both the groups ventilator settings are adjusted to so as to keep end tidal CO2level of 35 - 40 mm of Hg. In both the groups RR is increased/decreased by 2 breaths increments every minute so as to maintain the target ETCO2.Once it reached 20 bpm, in VCV group if required, TV is adjusted 25 ml increments every minute maximum up to 10 ml/kg, while in PCV group inspiratory pressure increased/decreased by 2 cm of H2O increments every minute so as to maintain the target ETCO2.In any patients if need arises to keep TV more than 10 ml/kg and or P peak raises more than 35 cm of H2O such patients will be excluded from the study.

In all patients, carbon dioxide pneumoperitoneum will be performed with intraabdominal pressure of 12 mm Hg.  Trendelenburg position will be set around 30 degrees. Intra operatively heart rate(HR), systolic blood pressure(SBP), diastolic blood pressure(DBP), and mean arterial blood pressure(MABP), peal inspiratory pressure(P peak), mean airway pressure (P mean), Expired tidal volume(TV), minute volume, oxygen saturation, and end-tidal carbon dioxide will be monitored at regular intervals, and data will be recorded at following point of time: 10 minutes after induction, in the supine position (baseline, or T1); after creation of pneumo-peritoneum and achieving a stable end tidal carbon dioxide (ETCO2) level of 35-40 mm of Hg for 5 minutes (T2)15 minutes after pneumoperitoneum, in the Trendelenburg position (pneumo-trend, or T3); and 10 minutes after pneumoperitoneum withdrawal, in the supine position (final, or T4). Mean operative time, pneumoperitoneum time, anaesthesia time, and complications will also be recorded. Further anaesthesia management will be carried out as per institution protocol. After the completion of surgery, the surgeons are questioned for their subjective evaluation of surgical working conditions during the laparoscopic gynecologic surgery.

 

Continuous data are expressed as mean+SD and categorial data will be expressed as frequency and percentage. Data will be entered in MS excel sheet.  Appropriate statistical tests will be applied using IBM SPSS latest version. A p value less than 0.05 is considered as statistically significant.

 
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