| CTRI Number |
CTRI/2024/10/075734 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study to compare the ease of handling technique between Lryngeal Mask Airway device and i-Gel device. |
|
Scientific Title of Study
|
Comparison of Proseal Laryngeal Mask Airway with i-Gel in Elective Urological Surgeries - A Randomized clinical 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 Meera Rani Nayak |
| Designation |
Professor |
| Affiliation |
Dr. Kamakshi Memorial Hospital |
| Address |
Department of Anaesthesia,
Dr. Kamakshi Memorial Hospital
No.1, Radial Road, Pallikaranai,
Chennai – 600 100, Tamil Nadu
Chennai
TAMIL NADU
600100
India |
| Phone |
8778024216 |
| Fax |
|
| Email |
paedsalex@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meera Rani Nayak |
| Designation |
Professor |
| Affiliation |
Dr. Kamakshi Memorial Hospital |
| Address |
Department of Anaesthesia,
Dr. Kamakshi Memorial Hospital
No.1, Radial Road, Pallikaranai,
Chennai – 600 100, Tamil Nadu
TAMIL NADU
600100
India |
| Phone |
8778024216 |
| Fax |
|
| Email |
paedsalex@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meera Rani Nayak |
| Designation |
Professor |
| Affiliation |
Dr. Kamakshi Memorial Hospital |
| Address |
Department of Anaesthesia,
Dr. Kamakshi Memorial Hospital
No.1, Radial Road, Pallikaranai,
Chennai – 600 100, Tamil Nadu
TAMIL NADU
600100
India |
| Phone |
8778024216 |
| Fax |
|
| Email |
paedsalex@gmail.com |
|
|
Source of Monetary or Material Support
|
| C/O: Dr Adhilakshmi R,
Department of Anaesthesia,
Dr. Kamakshi Memorial Hospital,
1, Radial Road, Pallikaranai
Chennai – 600100, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
ADHILAKSHMI R |
| Address |
Department of Anaesthesia,
Dr. Kamakshi Memorial Hospital,
1, Radial Road, Pallikaranai
Chennai – 600100, Tamil Nadu, India
|
| 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 ADHILAKSHMI R |
Dr. Kamakshi Memorial Hospital |
Department of Anaesthesia,
General Operation Theater Division,
Room No. 4, New Block, Third Floor,
Dr.Kamakshi Memorial Hospital,
No.1, Radial Road, Pallikaranai,
Chennai – 600100, Tamil Nadu, India
Chennai
TAMIL NADU |
9551607800
adhi2203@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee , Dr Kamakshi Memorial Hospital Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Airway maintenance using Proseal LMA device |
LMA proseal device will be lubricated on the tip and the posterior surface as per user manual. It will be inserted after inducing anesthesia to maintain airway. |
| Intervention |
Airway maintenance using i-Gel device |
i-Gel device will be lubricated on the tip and the posterior surface as per user manual. It will be inserted after inducing anesthesia to maintain airway. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged 18-65 years.
2. Scheduled for elective urological (less than 4 hours) surgery under general anesthesia.
3. American Society of Anesthesiologists (ASA) physical status I or II.
|
|
| ExclusionCriteria |
| Details |
Patients requiring
1. Endotracheal intubation Emergency surgeries.
2. Known or anticipated difficult airway.
3. Prolonged surgical procedures for more than 4 hours
4. At risk of aspiration (pregnancy and gastro esophageal reflex disease)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic Changes |
At baseline,
At 1st Minute,
At 5th Minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Airway seal pressure (cmH2O).
Hemodynamic stability (heart rate, respiratory rate, spo2 and blood pressure).
Complications (postoperative sore throat).
|
1 HOUR |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
01/11/2024 |
| 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="0"
Months="11"
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
|
This study proposal outlines a randomized controlled trial (RCT) aimed at comparing the Proseal Laryngeal Mask Airway (Proseal LMA) with the i-Gel in adult patients undergoing elective urological surgery. The primary objective is to assess and compare the efficacy, safety, and feasibility of these two airway management devices in terms of insertion success, airway sealing, and hemodynamic complications. The study will contribute to the evidence base, guiding anesthesiologists in choosing the most suitable airway device for elective surgical procedures. |