| 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
|
|
|
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
|
|
|
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
|
|
|
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. |