| CTRI Number |
CTRI/2024/06/069014 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational comparative study to evaluate the eye pressure changes in patients undergoing spine surgery in lying facedown position under Total Intravenous Anaesthesia versus Balanced Anaesthesia |
|
Scientific Title of Study
|
An observational comparative study to evaluate the ocular changes in patients undergoing spine surgery in prone position under Total Intravenous Anaesthesia versus Balanced Anaesthesia |
| 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 SANDHYA B K |
| Designation |
SENIOR RESIDENT |
| Affiliation |
M S RAMAIAH MEDICAL COLLEGE AND HOSPITAL(RUAS) |
| Address |
Department of anaesthesiology, 2nd floor,Ramaiah medical college and Hospital,MSR Nagar, Msrit post, Bengaluru
Bangalore
KARNATAKA
560054
India |
| Phone |
9538530275 |
| Fax |
|
| Email |
sandhya15ashok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANDHYA B K |
| Designation |
SENIOR RESIDENT |
| Affiliation |
M S RAMAIAH MEDICAL COLLEGE AND HOSPITAL(RUAS) |
| Address |
Department of Anaesthesiology,2nd floor, OPERATION THEATRE,Ramaiah medical college and hospital ,MSR Nagar , Msrit post, Bengaluru 560054
KARNATAKA
560054
India |
| Phone |
9538530275 |
| Fax |
|
| Email |
sandhya15ashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANDHYA B K |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Ramaiah Medical college and Hospital,Ramaiah University of Applied Sciences |
| Address |
Department of Anaesthesiology,2nd floor, Operation theatre,Ramaiah medical college and hospital MSR Nagar, Msrit post, Bengaluru
Bangalore
KARNATAKA
560054
India |
| Phone |
9538530275 |
| Fax |
|
| Email |
sandhya15ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, 2nd floor,Ramaiah medical college and Hospital,MSR Nagar, Msrit,Bengaluru-560054,Karnataka,India. |
|
|
Primary Sponsor
|
| Name |
Operation TheatreM S Ramaiah medical college and hospital |
| Address |
M S Ramaiah medical college and hospital,
MSR Nagar, Msrit post, Bengaluru 560054,Karnataka. |
| Type of Sponsor |
Private 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 SANDHYA B K |
Ramaiah medical college and hospital |
Operation theatre ,2nd floor RMCH,1st floor RMH, MSR Nagar, Msrit Post, Bengaluru-560064
Bangalore
KARNATAKA |
9538530275
sandhya15ashok@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAMAIAH MEDICAL COLLEGE ETHICS COMMITEE |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing spine surgery (thoracolumbar)
2. Less than 4 hours duration of surgery
3. Prone position
4. ASA I &II
|
|
| ExclusionCriteria |
| Details |
1. Refusal to consent for proposed study,
2. ASA III &IV
3. Any history of Glaucoma
4. Any ocular surgery(less than 3 months)
5. Cervical spine surgery
6. Chronic neck pain, or cervical stenosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measure the Intraocular pressure at various intervals in both groups to observe and compare the better outcome of ocular changes |
IOP1-before induction
IOP2- 5 min After induction
IOP3- 5 min After Supine position at the end of surgery
IOP4- 5 min After extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| heart rate, mean arterial pressure,SpO2 |
Time(mins)
0 min
5 min
10 min
15 min
20 min
25 min
30 min
35 min
40 min
45 min
50 min
1 hr
15 min
30 min
45 min
2 hrs
15 min
30 min
45 min
3 hrs
15 min
30 min
45 min
4 hrs
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/07/2024 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - on request in mail by the querer on proposed plan for use of information.
- For how long will this data be available start date provided 23-11-2025 and end date provided 23-01-2026?
Response (Others) - 3 months after publication
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
We propose to conduct a observational
comparative study of the ocular pressure changes- intraocular pressure(IOP),mean arterial
pressure( MAP) ,ocular perfusion pressure(OPP) in patients undergoing spine surgery in prone position
when maintained intraoperatively under Total intravenous anaesthesia versus Balanced Anaesthesia. Prone position
is used for posterior approach in spine surgery, such positioning is known to
cause ocular changes due to pressure on the orbital content and the altered
hemodynamics(MAP) leading to increase intraocular blood volume thus IOP and
OPP; hypoxia to optic nerve, ischemic optic neuropathy ,visual loss are some of
the ocular changes observed. Thus the study is done in comparison to establish
a protocol to prevent and anticipate the ocular changes. Patients will undergo pre anaesthetic checkup prior to surgery.
Informed consent will be obtained from patients who meet the inclusion criteria.
We will measure IOP, MAP, HR before induction, 5 min after induction and at the
end in supine position, 5 min after extubation then OPP will be calculated from
IOP and MAP, post-operative outcome and any adverse events during the surgery
will be recorded. |