| CTRI Number |
CTRI/2018/06/014676 [Registered on: 29/06/2018] Trial Registered Prospectively |
| Last Modified On: |
29/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of proseal Laryngeal Mask Airway And The I-Gel On Blood Pressure,Heart Rate,Respiratory Mechanics In Patients In Patients Undergoing Laprascopic Cholecystectomy |
|
Scientific Title of Study
|
A Comparative Study Of Proseal Laryngeal Mask Airway Versus The I-Gel On Hemodynamics And Respiratory Mechanics In Patients Undergoing Laproscopic Cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyesh Kumar |
| Designation |
M D Trainee |
| Affiliation |
Igims |
| Address |
Department Of Anaesthesia Igims Patna
Patna
BIHAR
800014
India |
| Phone |
9631986907 |
| Fax |
|
| Email |
dr.priyesh007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K H Raghwendra |
| Designation |
Professor |
| Affiliation |
Igims |
| Address |
Department Of Anaesthesia Igims Patna
Patna
BIHAR
800014
India |
| Phone |
9835092798 |
| Fax |
|
| Email |
dr.khraghwendra@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyesh Kumar |
| Designation |
M D Trainee |
| Affiliation |
Igims |
| Address |
Department Of Anaesthesia Igims Patna
Patna
BIHAR
800014
India |
| Phone |
9631986907 |
| Fax |
|
| Email |
dr.priyesh007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute Of Medical Sciences Patna Bihar |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute Of Medical Sciences |
| Address |
Sheikhpura Patna |
| 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 |
| Priyesh Kumar |
Indira Gandhi Institute Of Medical Sciences |
Operation Theatre
Patna
BIHAR |
9631986907
dr.priyesh007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Igims,Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA Grade 1 and 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I-Gel |
Effect On Hemodynamics And Respiratory Mechanics In Patients Undergoing Laprascopic Cholecystectomy |
| Intervention |
Proseal Laryngeal Mask Airway |
Effect On Hemodynamics And Respiratory Mechanics In Patients Undergoing Laprascopic Cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 And 2
Body Weight Between 50-60Kg
Patients Undergoing Laprascopic Cholecystectomy |
|
| ExclusionCriteria |
| Details |
Patients Refusal
ASA 3 And 4
History Of Allergy To One Or More Drug
Patients With Acute Cholecystitis
Any History Of Cardiopulmonary,Renal,Neurological and Psychiatric Disorders
Morbid Obesity
Patients With Previous H/O Abdominal Surgery
Those In Whom Procedure Has To Be Converted To Open Cholecystectomy
Limited Mouth Opening And Oral/Hypopharngeal Mass |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Monitoring Of ecg,non invasive blood pressure,oxygen saturation,Etco2 |
Mesurement Of HR,SBP,DBP,ETco2 at 1,3,5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Monitoring Of ecg,non invasive blood pressure,oxygen saturation,Etco2 |
Mesurement Of HR,SBP,DBP,ETco2 at 1,3,5 minutes |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/06/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Aim Of This Study Is To compare the respiratory mechanics,hemodynamic changes,attempts taken for insertion,oxygenation,intraoperative and post operative laryngopharyngeal morbidity using either P-LMA or I-GEL in adult patient undergoing laprascopic cholecystectomy |