| CTRI Number |
CTRI/2022/02/040672 [Registered on: 28/02/2022] Trial Registered Prospectively |
| Last Modified On: |
10/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Changes in optic nerve sheath diameter and intraocular pressure of both eyes during prone position surgeries |
|
Scientific Title of Study
|
Changes in Optic Nerve Sheath Diameter and Intraocular Pressure as a surrogative marker of postoperative visual loss in patients undergoing surgery in prone position – Prospective Observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Vinothkumar |
| Designation |
Assistant Professor |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
| Address |
Department of Anesthesiology,
Room no:1,First floor,
Melmaruvathur Adhiparasakthi Institute of Medical sciences and Research,
Melmaruvathur
Department of Anesthesiology,
Room no:1,First floor,
Melmaruvathur Adhiparasakthi Institute of Medical sciences and Research,
Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8807327384 |
| Fax |
|
| Email |
vkmaestroz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Vinothkumar |
| Designation |
Assistant Professor |
| Affiliation |
Melmaruvathur Adhiparassakthi Institute of Medical Sciences and research |
| Address |
Department of Anesthesiology,
Room no:1,First floor,
Melmaruvathur Adhiparasakthi Institute of Medical sciences and Research,
Melmaruvathur
Department of Anesthesiology,
Room no:1,First floor,
Melmaruvathur Adhiparasakthi Institute of Medical sciences and Research,
Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8807327384 |
| Fax |
|
| Email |
vkmaestroz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Vinothkumar |
| Designation |
Assistant Professor |
| Affiliation |
Melmaruvathur Adhiparassakthi Institute of Medical Sciences and Research |
| Address |
Department of Anesthesiology,
Room no:1,First floor,
Melmaruvathur Adhiparasakthi Institute of Medical sciences and Research,
Melmaruvathur
Department of Anesthesiology,
Room no:1,First floor,
Melmaruvathur Adhiparasakthi Institute of Medical sciences and Research,
Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8807327384 |
| Fax |
|
| Email |
vkmaestroz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research,
Melmaruvathur,
Tamilnadu - 603319 |
|
|
Primary Sponsor
|
| Name |
Melmaruvathur Adhiparasakthi Institute of medical sciences and research |
| Address |
Melmaruvathur
Tamilnadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 A Vinothkumar |
Melmaruvathur Adhiparasakthi Institute of medical science and research |
Department of Anesthesiology,
Room no:1,First floor,
Melmaruvathur Adhiparasakthi Institute of Medical sciences and Research,
Melmaruvathur
Kancheepuram
TAMIL NADU |
8807327384
vkmaestroz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(Human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: N20-N23||Urolithiasis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) physical status I , II |
|
| ExclusionCriteria |
| Details |
a. Patient refusal
b. Pre-existing eye disease (diabetic retinopathy, corneal opacity, glaucoma and retinal detachment),
c. History of eye and neck surgery,
d. Trauma patients,
e. Haemoglobin ≤ 10g/dl,
f. Blood Loss ≥ 1000ml,
g. Age > 60 years,
h. BMI ≥ 40,
i. American Society of Anaesthesia (ASA) physical status III and above,
j. Severe anaphylactic allergy to ultrasound gel.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Theprimary outcome of the study is to investigate the influence of prone position on ONSD of both eyes in patients undergoing surgery under prone position. |
ONSD of both eyes will measured during Patient awake in supine position before induction of anaesthesia (T0)
2. Ten minutes after induction of anesthesia and in supine position (T1)
3. Ten minutes into acquiring prone position (T2)
4. At the end of the operation in prone position (T3)
5. Ten minutes into acquiring supine position before the reversal injection and the change in depth of anesthesia (T4)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To investigate the influence of prone position on IOP of both eyes in patients undergoing surgery under prone position.
2. To find out the influence of age, sex, Body Mass Index (BMI), Peak Inspiratory Pressure (PIP), Mean Arterial Blood Pressure (MAP), Duration of surgery, End Tidal Isoflurane and ETCO2 on IOP and ONSD of both eyes during prone position
|
1.Ten minutes into acquiring prone position (T2)
2. At the end of the operation in prone position (T3) |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2022 |
| Date of Study Completion (India) |
31/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
study completed yet to publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
1. Post-operative visual loss (POVL) is an unfortunate, horrifying, and rare complication that is among the legal complaints. It has been mostly reported in surgeries requiring prone position. Postoperative visual loss (POVL) following prone spine surgery occurs in 0.013% to 1% of cases. In our study we observed significant increase in intraocular pressure and optic nerve sheath diameter during prone postion in spine surgeries which returned to baseline while changing position from prone to supine. No patients developed postoperative visual loss or eye complications in our study. |