| CTRI Number |
CTRI/2025/07/091781 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| 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
|
COMPARISION OF TWO SUPRAGLOTTIC AIRWAY DEVICES IN SECURING AIRWAY IN ADULT PATIENTS |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION BETWEEN I-GEL AND
PROSEAL LARYNGEAL MASK AIRWAY FOR OROPHARYNGEAL LEAK
PRESSURE IN PATIENTS UNDERGOING SURGERY UNDER GENERAL
ANAESTHESIA - A PROSPECTIVE RANDOMISED CLINICAL STUDY |
| 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 MOHAMMAD NAUSHAD ALAM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE, ALIGARH MUSLIM UNIVERSITY, ALIGARH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE, ALIGARH MUSLIM UNIVERSITY, ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9528783744 |
| Fax |
|
| Email |
naushad0575@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SYED HUSSAIN AMIR |
| Designation |
PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE, ALIGARH MUSLIM UNIVERSITY, ALIGARH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE, ALIGARH MUSLIM UNIVERSITY, ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897559183 |
| Fax |
|
| Email |
hussainamir77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SYED HUSSAIN AMIR |
| Designation |
PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE, ALIGARH MUSLIM UNIVERSITY, ALIGARH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE, ALIGARH MUSLIM UNIVERSITY, ALIGARH
UTTAR PRADESH
202002
India |
| Phone |
9897559183 |
| Fax |
|
| Email |
hussainamir77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care
JNMCH, AMU, Aligarh, UP, 202002 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU, Aligarh |
| 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 Mohammad Naushad Alam |
JNMC Hospital |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU
Aligarh
UTTAR PRADESH |
9528783744
naushad0575@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade: I and II
Weight: 30 to 70 kg
MP Grade: I to IV |
|
| ExclusionCriteria |
| Details |
Any pathology of the oral cavity that may obstruct the insertion of devices.
Mouth opening less than 2.5 cm.
Expected during of surgery longer than 2 hours.
Potentially full stomach patients (trauma, morbid obesity, pregnancy, history of gastric regurgitation and heart burn) and at risk of esophageal reflux (hiatus hernia).
Bleeding disorders.
Lack of consent to participate in the study. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal Leak Pressure |
Oropharyngeal Leak Pressure at the time of insertion and after 10 min of insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of insertion of the study device |
Time taken to insert the study device after induction |
| Number of attempts for placement of study device (1/2/F) |
Time taken to insert the study device after induction |
| Laryngeal view score/grade using POGO score |
POGO score (0%, 33%, 100%) |
| Ease of insertion of study device |
Number of adjustment manoeuvers (1, 2, 3) |
| Changes in heart rate and mean arterial pressure following insertion and removal of device. |
|
| Complications |
Trauma of lip, tougue, pharynx
Blood staining in devices
Sore Throat, Hoarseness of voice |
|
|
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)
|
12/08/2025 |
| 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 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
|
TITLE OF THESIS: A COMPARATIVE EVALUATION BETWEEN I-GEL AND PROSEAL LARYNGEAL MASK AIRWAY FOR OROPHARYNGEAL LEAK PRESSURE IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA - A PROSPECTIVE RANDOMISED CLINICAL STUDY
ANAESTHETIC PROCEDURE: In the operating room, standard monitoring including ECG, pulse oximetry, non-invasive BP, end-tidal carbon dioxide will be attached. Intravenous(iv) access with be secured. Anaesthetic technique shall comprise of a uniform pre-medication with Inj.Glycopyrolate 0.01 mg/kg iv, Inj.Midazolam 0.03 mg/kg iv, Inj.Fentanyl 1.5mcg/kg iv and Inj.Dexamethasone 0.1 mg/kg iv. All these drugs will be given intravenously 15 minutes prior to transfer of the patient to operating room. After preoxygenation with 100% Oxygen for 3 min, anaesthesia will be induced with Inj.Propofol 2 mg/kg iv. After adequate muscle relaxation with Inj.Vecuronium 0.1mg/kg, supraglottic airway devices will be inserted depending on the group to which the patient is assigned. Now the device will be attached to circuit system and anaesthesia will be maintained with 60% Nitrous Oxide in Oxygen with Vecuronium Bromide and Isoflurane(0.5%).After preoxygenation with 100% Oxygen for 3 min, anaesthesia will be induced with Inj.Propofol 2 mg/kg iv. After adequate muscle relaxation with Inj.Vecuronium 0.1mg/kg, supraglottic airway devices will be inserted depending on the group to which the patient is assigned. Now the device will be attached to circuit system and anaesthesia will be maintained with 60% Nitrous Oxide in Oxygen with Vecuronium Bromide and Isoflurane(0.5%).
1. Oropharyngeal Leak Pressure: 2. Time of insertion of the study device: 3. Number of attempts for placement of device (1/2/F): 4. Laryngeal view score/grade: Grade I “full view of the glottis” (Full) - POGO 100% Grade II “posterior commissure” (Partial) - POGO 50% Grade III “only arytenoids” (None) - POGO 0% 4. Ease of insertion of device: Grade I: Grade II: Grade III: 5. Changes in heart rate and mean arterial pressure following insertion and removal of device:
|