| CTRI Number |
CTRI/2025/07/090376 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Blood Pressure Changes During Supraglottic Airway Insertion in Patients with High Blood Pressure |
|
Scientific Title of Study
|
Hemodynamic changes during and after i-Gel and Baska Mask insertion in patients with Hypertension ,a randomised 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 |
DrTamilmaniJ |
| Designation |
Post Graduate |
| Affiliation |
Karpaga vinayaga Institute of Medical Sciences and Research Centre. |
| Address |
Medical college hospital campus,
1st floor, OT complex,
Karpaga vinayaga Institute of Medical Sciences and Research Centre.
Chinnakolambakkam
Madhuranthagam
Tamilnadu.
603308
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8825494065 |
| Fax |
|
| Email |
jaisankartamil12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTamilmaniJ |
| Designation |
Post Graduate |
| Affiliation |
Karpaga vinayaga Institute of Medical Sciences and Research Centre. |
| Address |
Medical college hospital campus,
1st floor, OT complex,
Karpaga vinayaga Institute of Medical Sciences and Research Centre.
Chinnakolambakkam
Madhuranthagam
Tamilnadu.
603308
TAMIL NADU
603308
India |
| Phone |
8825494065 |
| Fax |
|
| Email |
jaisankartamil12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTamilmaniJ |
| Designation |
Post Graduate |
| Affiliation |
Karpaga vinayaga Institute of Medical Sciences and Research Centre. |
| Address |
Medical college hospital campus,
1st floor, OT complex,
Karpaga vinayaga Institute of Medical Sciences and Research Centre.
Chinnakolambakkam
Madhuranthagam
Tamilnadu.
603308
TAMIL NADU
603308
India |
| Phone |
8825494065 |
| Fax |
|
| Email |
jaisankartamil12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical college hospital campus, 1st floor, OT complex, Karpaga vinayaga Institute of Medical Sciences and Research Centre. Chinnakolambakkam Madhuranthagam Tamilnadu. 603308 |
|
|
Primary Sponsor
|
| Name |
Dr. Tamilmani. J |
| Address |
Medical college hospital campus,
1st floor,
OT complex,
Karpaga vinayaga Institute of Medical Sciences and Research Centre.
Chinnakolambakkam.
Madhuranthagam.
603308 |
| 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 Manohar P |
Karpaga vinayaga institute of Medical sciences and Research Centre |
1st Floor,
OT complex
Medical college hospital campus
Karpaga vinayaga institute of Medical sciences and Research Centre
Chinnakolambakkam
Madhuranthagam
TamilNadu
India.
603308
Kancheepuram
TAMIL NADU |
8903032609
dr.manoth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitiee, Karpaga Vinayaga Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I-GEL and Baska mask |
Comparing both supraglottic airway devices for better hemodynamic changes. |
| Intervention |
Intubation with Supraglottic airway device |
i-GEL and Baska mask insertion in Hypertensive patients under general anaesthesia for upto 7 minutes after insertion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Hypertensive patients posted for elective surgery under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Patients with severe cardiovascular disease (e.g., acute myocardial infarction, unstable angina, severe heart failure)
2.Patients with severe respiratory disease (e.g., severe chronic obstructive pulmonary disease, severe asthma)
3.Patients with known contraindications to supraglottic airway devices (e.g., facial trauma, pharyngeal pathology)
4.Patients with anticipated difficult airway
5.Pregnant patients
6.Patients who refuse to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in hemodynamic parameters during & after insertion of i-Gel and Baska mask.
|
Baseline at 1 hour before surgery
After shifting inside OT
1 minute after insertion
3 minutes after insertion
5 minutes after insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to insert.
Number of attempts.
Adverse events. |
1 minute, 3 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
|
N/A |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
General anaesthesia is usually done by securing a definitive airway. Endotracheal intubation by laryngoscopy is one of the most famous and frequent method for securing airway. But conduct of laryngoscopy and intubation of the trachea with endotracheal tube most of the time results in transient tachycardia, varied arrhythmias and hypertension due to sympathetic response and release of catecholamines. Other methods of securing airway like usage of laryngeal mask airway (LMA) have been used in frequently during GeneralAnaesthesia. The haemodynamic changes during insertion of LMA under General Anaesthesia are less than that of tracheal intubation. |