| CTRI Number |
CTRI/2025/11/097938 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing how Proseal LMA and IGel airway devices affect the hemodynamic parameters during laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparision Of Heamodynamic Profile Of I-Gel and Proseal LMA In Laparoscopic Cholecystectomy |
| 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 SUDHEEKSHA S |
| Designation |
Junior Resident |
| Affiliation |
Shimoga Institute Of Medical Sciences Shimoga |
| Address |
Department Of Anesthesiology Major OT Complex 3rd Floor Mcgaan District Teaching Hospital Shimoga Institute Of Medical Sciences Shimogga karnataka
Department Of Anesthesiology Major OT Complex 3rd Floor Mcgaan District Teaching Hospital Shimoga Institute Of Medical Sciences Shimogga karnataka
Shimoga
KARNATAKA
577201
India |
| Phone |
9148882303 |
| Fax |
|
| Email |
sudheekshas06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KUMARA A B |
| Designation |
Associate Professor |
| Affiliation |
Shimoga Institute Of Medical Sciences Shimogga |
| Address |
Department Of Anesthesiology Major OT Complex 3rd Floor Mcgaan District Teaching Hospital Shimoga Institute Of Medical Sciences Shimogga karnataka
Department Of Anesthesiology Major OT Complex 3rd Floor Mcgaan District Teaching Hospital Shimoga Institute Of Medical Sciences Shimogga karnataka
Shimoga
KARNATAKA
577201
India |
| Phone |
918861958933 |
| Fax |
|
| Email |
kumarab_bmc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr KUMARA A B |
| Designation |
Associate Professor |
| Affiliation |
Shimoga Institute Of Medical Sciences Shimogga |
| Address |
Department Of Anesthesiology Major OT complex 3rd Floor Mcgaan District Teaching Hospital Shimoga Institute Of Medical Sciences Shimogga karnataka
Department Of Anesthesiology Major OT Complex 3rd Floor Mcgaan District Teaching Hospital Shimoga Institute Of Medical Sciences Shimogga karnataka
Shimoga
KARNATAKA
577201
India |
| Phone |
918861958933 |
| Fax |
|
| Email |
kumarab_bmc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr SUDHEEKSHA S |
| Address |
Department Of Anesthesiology Major OT Complex 3rd Floor Mcgaan District Teaching Hospital Shimoga Institute Of Medical Sciences Shimogga Karnataka 577201 |
| Type of Sponsor |
Other [Self] |
|
|
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 KUMARA A B |
Dr SUDHEEKSHA |
Department Of Anesthesiology Major OT Complex 3rd Floor Mcgaan District Teaching hospital Shimoga institute of medical sciences Shimogga karnataka
Shimoga
KARNATAKA |
91488 82303
sudheekshas06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Airway intervention |
Securing Supraglottic Airway Devices With General Anesthesia And Monitoring Hemodynamic Parameters Until 5 Minutes After Removal Of Device |
| Comparator Agent |
Supraglottic airway devices |
Comparison Of Hemodynamic Parameters between Proseal LMA and IGel Until 5 Minutes After Removal Of The Devices |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
BMI 18- 25 kg/m2
ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with a high risk of aspiration including hiatus hernia and pregnancy and
GERD.
Anticipated difficult airway and pathology of neck and upper respiratory tract and
mouth opening less than 2.5 cm.
Procedures requiring preoperative nasogastric tube placement and nasal and oral airway
Duration of surgery that exceeds 90 minutes
Chronic discases such as uncontrolled hypertension and uncontrolled diabetes
mellitus and bronchitis and bronchial asthma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparision of heamodynamic profile of Igel and proseal lma in laparoscopic cholecystectomy |
T(0) - before induction
T(1) - just before insertion
T(2) - just after insertion
T(3) - 1min
T(4) - 3min
T(5) - 5min
T(6) - after carboperitonium
T(7) - 15min
T(8) - 30min
T(9) - 45min
T(10) - 60min
T(11)- 90min
T(12) - immediately after removal
T(13) - 5min after removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparision of airway parameters |
T(0) - at the time os insertion
T(1) - at the time of removal
T(2) - 1hour after surgery |
|
|
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)
|
15/12/2025 |
| 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 Yet Recruiting |
| 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
|
Second generation supraglottic devices such as proseal lma and igel have replaced the classical laryngeal mask airway as they form more effective seal and has a port that facilitates the suction of gastric contents and prevent gastric insufflation and regurgitation. Even though endotrachial intubation is gold standard method in laparoscopic surgeries recently designed LMAs secure the airway with fewer complications and lesser hemodynamic changes as a substitute to endotracheal intubation. In this study we are comapring the heamodynamic changes between proseal lma and igel insertion . |