| CTRI Number |
CTRI/2025/07/091529 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Proseal laryngeal mask airway and igel effect on optic nerve sheath diameter changes in hypertensive patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Effect of Proseal laryngeal mask airway and igel on ultrasound guided changes in optic nerve sheath diameter in hypertensive patients undergoing general anaesthesia:A randomised comparative 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 |
Ayush singh |
| Designation |
Pg Resident |
| Affiliation |
ABVIMS and Dr. Rml hospital,New Delhi |
| Address |
Room 301,Department of Anaesthesia,3rd floor,Pgimer building,Dr. Ram Manohar Lohia hospital,Central Delhi
Central
DELHI
110001
India |
| Phone |
7250358843 |
| Fax |
|
| Email |
Ayushssingh1599@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Namita Saraswat |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia hospital,New Delhi |
| Address |
Room no. 301 3rd floor Department of anaesthesia ABVIMS and Dr. Rml hospital,Central Delhi 110001 , New Delhi
Central
DELHI
110001
India |
| Phone |
9953594082 |
| Fax |
|
| Email |
Drnamitasaraswat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namita Saraswat |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia hospital,New Delhi |
| Address |
Room no. 301 3rd floor Department of anaesthesia ABVIMS and Dr. Rml hospital,Central Delhi 110001 , New Delhi
Central
DELHI
110001
India |
| Phone |
9953594082 |
| Fax |
|
| Email |
Drnamitasaraswat@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. Ram Manohar Lohia Hospital,Baba Kharak Singh Margarita,near Gurudwara Bangla Sahib, Connaught palace,New Delhi 110001,Central Delhi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Ayush singh |
ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi |
Room no. 301,3rd floor Department of anaesthesia ABVIMS and Dr. RML HOSPITAL,Central Delhi 110001,New Delhi
Central
DELHI |
7250358843
ayushssingh1599@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS and Dr. RML Hospital,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Igel |
After case is induced igel will be introduced to secure airway of the patient |
| Comparator Agent |
laryngeal mask airway proseal |
After case is induced laryngeal mask airway will be introduced to secure airway of the patient |
| Intervention |
Ultrasound guided optic nerve sheath diameter changes |
Upon introducing Proseal laryngeal mask airway/i-gel effect of change in optic nerve sheath diameter is observed using ultrasound machine at baseline (T0),1 minute (T1),5 minutes(T5) and 10 minutes(T10) after induction.
Measuring ONSD will take around 10 seconds each time. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologists (ASA) grade II/III patients aged 18-65 years. Hypertensive patients undergoing elective surgery under general anaesthesia.Mallampati class (MPG) I and II |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway.Any ophthalmic injury.Optic nerve pathology.Body mass index greater than 30.History of cerebral vascular accidents.History of head injury.History of any neurological disorder.History of ophthalmic surgery or neurosurgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Optic nerve sheath diameter (ONSD) in both the groups at T0, T1, T5 and T10
1. Baseline ONSD value before induction (T0)
2. ONSD value after 1 minute inserting ProSeal LMA/I-Gel (T1)
3. ONSD value after 5 minutes inserting ProSeal LMA/I-Gel (T5)
4. ONSD value after 10 minutes inserting ProSeal LMA/I-Gel (T10) |
Optic nerve sheath diameter (ONSD) in both the groups at T0, T1, T5 and T10
1. Baseline ONSD value before induction (T0)
2. ONSD value after 1 minute inserting ProSeal LMA/I-Gel (T1)
3. ONSD value after 5 minutes inserting ProSeal LMA/I-Gel (T5)
4. ONSD value after 10 minutes inserting ProSeal LMA/I-Gel (T10) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic response (SBP, DBP, MAP & HR) in both the groups at T0, T1, T5 & T10
2. Co-relation of hemodynamic changes with changes in ONSD at T0, T1, T5 & T10 |
T0 is baseline(before induction )
T1-after 1 minute
T5-after 5 minutes
T10-after 10 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ayushssingh1599@gmail.com].
- For how long will this data be available start date provided 11-07-2025 and end date provided 10-11-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The group will be divided into Group P or in the Group I. Group P-people in which we will introduce ProSeal as a supraglottic airway device (SAD) after induction Group I-people in which we will introduce I-gel as a supraglottic airway device (SAD) after induction Preoperative anaesthetic examination will be done and patient will be advised to keep fasting 6 hours for solids and 2 hours of clear liquid prior to the surgery. Upon arrival in the operating room, standard ASA monitor will be attached. T0 ONSD will be measured for the baseline value. I.V. cannula will be secured and Pre-oxygenation with 100% oxygen will be done for 3 minutes. Premedication with injection Midaz 1mg and fentanyl 2 mcg/kg will be given and all patients will undergo induction of general anaesthesia (GA) using intravenous induction with propofol 2 mg/kg and vecuronium 100 mcg/kg. Bag and mask will be done for 3 minutes with Oxygen: Air 50:50 and Sevoflurane to maintain the MAC of 1-1.2 After 3 minutes, we will introduce ProSeal/I-gel of correct size w.r.t the allotted group P/I and will fix the device. After securing the airway, patient will be kept on VCV (volume-controlled ventilation) mode with Tidal volume-8-10 ml/kg Respiratory Rate-12/minute and PEEP-5 cm H2O to maintain EtCO2 of 35-40mmHg with Oxygen: Air 50:50 and Sevoflurane to maintain the MAC of 1 Then we will observe the ONSD value at T1, T5 and T10 minutes after 1,5 and 10 minutes after securing the airway and before incision. Surgical incision will be given after obtaining T10 value |