| CTRI Number |
CTRI/2025/02/080333 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
OBSERVATIONAL PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
STUDY THE EFFECT OF PROPOFOL ANAESTHESIA ON CEREBRAL HEMODYNAMICS IN INFANTS UNDERGOING INGUINAL HERNIA REPAIR SURGERY |
|
Scientific Title of Study
|
A PROSPECTIVE OBSERVATIONAL STUDY TO STUDY THE EFFECT OF PROPOFOL ANAESTHESIA ON CEREBRAL HEMODYNAMICS IN INFANT UNDERGOING INGUINAL HERNIA REPAIR SURGERY |
| 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 SAMIKSHA PARASHAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Dr.Ram Manohar Lohia Institute of Medical Sciences VIBHUTI KHAND LUCKNOW |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE Dr.Ram Manohar Lohia Institute of Medical Sciences VIBHUTI KHAND LUCKNOW
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7042345280 |
| Fax |
|
| Email |
samikshaparashar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAMIKSHA PARASHAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Dr.Ram Manohar Lohia Institute of Medical Sciences VIBHUTI KHAND LUCKNOW |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE
Dr.Ram Manohar Lohia Institute of Medical Sciences VIBHUTI KHAND LUCKNOW
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7042345280 |
| Fax |
|
| Email |
samikshaparashar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DHANRAJ SINGH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr.Ram Manohar Lohia Institute of Medical Sciences VIBHUTI KHAND LUCKNOW |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE
Dr.Ram Manohar Lohia Institute of Medical Sciences VIBHUTI KHAND LUCKNOW
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9896699338 |
| Fax |
|
| Email |
docdhanrajsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Ram Manohar Lohia Institute of Medical Sciences LUCKNOW |
|
|
Primary Sponsor
|
| Name |
DrRam Manohar Lohia Institute of Medical Sciences |
| Address |
DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCE VIBHUTI KHAND GOMTI NAGAR LUCKNOW |
| 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 SAMIKASHA PRASHAR |
Dr.Ram Manohar Lohia Institute of Medical Sciences |
Ram Prakash Gupta Refferal Center DrRam manhor Lohia Institute of Medical Sciences OT complex 3rd floor Department of Pediatric surgery
Lucknow
UTTAR PRADESH |
7042345280
samikshaparashar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.Ram Manohar Lohia Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY INFANTS UNDERGOING IGUNIAL HERNIA REPAIR SURGERY |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transcranial ultrasound |
USING TRANSCRANIAL ULTRASOUND OBESEREVING CHANGES IN CEREBRAL HEMODYNAMICS OBSERVATIONAL STUDY ONLY |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
INFANT UNDERGOING ELECTIVE INGUINAL HERNIA REPAIR SURGERY UNDER GENERAL ANAESTHESIA
AMERICAN SOCIETY OF ANAESTHESOLOGISTS (ASA 1 AND 2 ) PHYSICAL STATUS |
|
| ExclusionCriteria |
| Details |
CARDIOVASCULAR OR NEUROLOGICAL DISEASE
HISTORY OF PREMATURE BIRTH |
|
|
Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
CORELATION OF MEAN ARTERIAL PRESSURE AND MFV MEAN FLOW VELOCITY ANTERIOR CEREBRAL ARTERY
USING DOPPLER SONOGRAPHY THROUGH ANTERIOR FONTANELLE DURING PROPOFOL ANESTHESIA |
BASELINE BEFORE PREOXYGENATION
EVERY 5 MINUTES FROM BASELINE TILL SHIFTING THE INFANT TO POST OPERATIVE WARD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO DETERMINE THE EFFECTS OF PROPOFOL ANAESTHESIA ON PSV DFV PI AND RESISTIVE INDEX |
BASELINE BEFORE PREOXYGENATION
EVERY 5 MINUTES FROM BASELINE TILL SHIFTING THE INFANT TO POST OPERATIVE WARD |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
25/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Infants undergoing surgery under general anaesthesia are at increased risk of subsequent neurodevelopmental delay. One mechanism contributing to such delay may be disturbances in cerebral perfusion during general anesthesia.This is due to impaired cerebral auto regulation leading to a pressure-passive cerebral circulation and reduced ability to maintain stable cerebral perfusion during general an aesthesia.Propofol is a common anaesthesia agent used for induction and maintenance of anaesthesia. The relation of change in mean arterial pressure and corresponding change in cerebral perfusion is not completely understood under propofol anaesthesia. The purpose of this study is to assess the impact of propofol anaesthesia on cerebral hemodynamic in infants undergoing inguinal hernia repair surgery, using brain Doppler sonography. |