| CTRI Number |
CTRI/2020/01/022860 [Registered on: 20/01/2020] Trial Registered Prospectively |
| Last Modified On: |
16/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess changes in Optic Nerve Sheath Diameter during Neurosurgery |
|
Scientific Title of Study
|
Perioperative variation in Optic Nerve Sheath Diameter measured by Transbulbar Ultrasonography in Neurological patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varun S |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Thiruvananthapuram |
| Address |
Department of Anaesthesiology
Government Medical College
Thiruvananthapuram
Thiruvananthapuram KERALA 695011 India |
| Phone |
|
| Fax |
|
| Email |
varunsureshpgi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Varun S |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Thiruvananthapuram |
| Address |
Department of Anaesthesiology
Government Medical College
Thiruvananthapuram
KERALA 695011 India |
| Phone |
|
| Fax |
|
| Email |
varunsureshpgi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Varun S |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Thiruvananthapuram |
| Address |
Department of Anaesthesiology
Government Medical College
Thiruvananthapuram
KERALA 695011 India |
| Phone |
|
| Fax |
|
| Email |
varunsureshpgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College
Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Dr Varun S |
| Address |
Assistant Professor
Department of Anaesthesiology
Government Medical College
Thiruvananthapuram |
| 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 Varun S |
Department of Anaesthesiology |
Government Medical College
Thiruvananthapuram
Thiruvananthapuram KERALA |
9041426743
varunsureshpgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HUMAN ETHICS COMMITTEE, Government Medical College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S065||Traumatic subdural hemorrhage, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with traumatic brain injury |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative variation in optic nerve sheath measured by Ultrasonography |
Optic nerve sheath diameter will be measured twice.
1. After induction of general anaesthesia and before surgery.
2. After surgery with the patient still under general anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
20/01/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Kim JY, Min HG, Ha SI, Jeong HW, Seo H, Kim JU. Dynamic optic nerve sheath diameter responses to short-term hyperventilation measured with sonography in patients under general anesthesia. Korean J Anesthesiol. 2014; 67(4): 240-5.
2. Kim SH, Kim HJ, Jung KT. Position does not affect the optic nerve sheath diameter during laparoscopy. Korean J Anesthesiol. 2015; 68(4): 358-63.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Achieving
optimum intracranial pressure is a core concept in neurosurgical disease. Transbulbar
sonography is yet to gain wide application in surgeries for primary
neurosurgical disease. Transbulbar sonography if well validated in this group
of patients can sooner or later replace or corroborate other methods of
intracranial pressure measurement. In this context the impact of intracranial
procedures on measurements of optic nerve sheath by sonograpy pre and
post-operatively attains relevance. As
transbulbar ONSD measurement by sonography is gaining much impetus, the
fallacies of this technique, if any, in primary neurosurgical disease need to
be clearly defined. Till date no studies have compared the application of
transbular sonography in primary neurosurgical procedures. Neurosurgical
procedures are associated fluctuations in ICP due to various reasons apart from
patient surgical position. This together with the inherent CSF loss through
dural incisions, use of external ventricular drains or external lumbar CSF
drains can further alter CSF flow dynamics. These changes can also affect the
CSF flow over the optic nerve sheath. This can be non-invasively measured by
transbulbar sonography. Till date no published studies have analysed the effect
of open neurosurgical procedures on CSF flow dynamics measured by ultrasonic
optic nerve sheath assessment. · We aim to evaluate the Optic
Nerve Sheath Diameter (ONSD) by ultrasonography in neurosurgical patients;
undergoing craniotomy (elective and emergency) in varied surgical positions;
preoperatively after induction of general anaesthesia and postoperatively
before reversal of neuromuscular blokade.
|