| CTRI Number |
CTRI/2024/09/074074 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
16/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of propofol with lidocaine on optic nerve sheath diameter in neurosurgical patients as an assessment of laryngoscopy response |
|
Scientific Title of Study
|
Comparison of Propofol with Lignocaine for attenuation of laryngoscopy and intubation induced response on Optic Nerve Sheath Diameter in neurosurgical patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashpal yadav |
| Designation |
PG ANESTHESIOLOGY |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital, NEW DELHI |
| Address |
Room no. 301,Department of Anesthesiology , Third floor , Acadmic section, PGI building, Baba Khadak Singh Marg , ABVIMS and DR.RML Hospital
Central
DELHI
110001
India |
| Phone |
9315560172 |
| Fax |
|
| Email |
yashyadav420420@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Itishri |
| Designation |
Associate Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital |
| Address |
Room no. 301,Department of Anesthesiology , Third floor , Acadmic section, PGI building, Baba Khadak Singh Marg , ABVIMS and DR.RML Hospital
Central
DELHI
110001
India |
| Phone |
9212400570 |
| Fax |
|
| Email |
Itianesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Itishri |
| Designation |
Associate professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences |
| Address |
ROOM NO. 301, 3RD FLOOR, DEPARTMENT OF ANAESTHESIA, PGI BULDING, ABVIMS AND DR. RML HOSPITAL, CENTRAL DELHI, INDIA
Central
DELHI
110001
India |
| Phone |
9212400570 |
| Fax |
|
| Email |
Itianesthesia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital, NEW DELHI -110001, INDIA |
|
|
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 Yashpal yadav |
Atal Bihari Vajpayee Institute of Medical Sciences, New delhi |
ROOM NO. 301, 3RD FLOOR, DEPARTMENT OF ANAESTHESIA, PGI BULDING, ABVIMS AND DR. RML HOSPITAL, CENTRAL DELHI, INDIA
Central
DELHI |
9315560172
yashyadav420420@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ABVIMS and Dr RML hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous [i.v.] lignocaine |
i.v. lignocaine 2% 1.5 mg/kg to group 2, 90 seconds before intubation. |
| Comparator Agent |
intravenous [i.v.] propofol |
i.v. propofol 1 mg/ kg to group 1, 90 seconds before intubation.
|
| Intervention |
measuring optic nerve sheath diameter via ultrasound as an indicator of intracrranial pressure. |
Comparison of Propofol with Lignocaine for attenuation of laryngoscopy and intubation induced response on Optic Nerve Sheath Diameter measured via ultrasound in neurosurgical patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Asa grade 1 and 2,
Elective neurosurgical procedure,
MP grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Laryngoscopy and Endotracheal intubation time more than 30 sec, Anticipated difficult airway, Baseline BP less than 100mmHg, Heart Rate less than 60 per min, Any ophthalmic injury, optic nerve pathology, Allergy to drugs used |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Optic nerve sheath diameter |
Baseline, 3min after mask ventilation,at intubation, one min after intubation, 5min after intubation, 15min after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart Rate, mean arterial pressure, SBP, DBP |
Baseline, 3min after mask ventilation,at intubation, one min after intubation, 5min after intubation, 15min after intubation |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="1"
Months="1"
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 - NO
|
|
Brief Summary
|
This is a comparative study of propofol with lignocaine for attenuation of laryngoscopy and intubation induced response on ONSD in patients undergoing neurosurgical procedure to be conducted in ABVIMS and Dr. RML Hospital, New Delhi-110001 with sample size 58 ( 29 in each group) |