| CTRI Number |
CTRI/2025/11/097627 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Postdoctoral Fellowship study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying how changes in the eyes pupil during spine surgery relate to the amount of pain medicine adults need |
|
Scientific Title of Study
|
Association between Perioperative Pupillary Parameters and Opioid Analgesic Requirements in Adult Spine Surgery A Prospective Observational Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranjana Sure |
| Designation |
Senior Resident |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Senior resident
Department of Neuroanaesthesia and Neurocritical care
National Institute of Mental health and Neurosciences(NIMHANS)
Bengaluru, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
8861680105 |
| Fax |
|
| Email |
ranjanasure@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta S Naik |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Associate Professor
Department of Neuroanaesthesia and Neurocritical care
NIMHANS
Bengaluru, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9845118260 |
| Fax |
|
| Email |
drshwethanaik85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ranjana Sure |
| Designation |
Senior Resident |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
3rd floor Faculty Building
Department of Neuroanaesthesia and Neurocritical care
NIMHANS
Bengaluru, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
8861680105 |
| Fax |
|
| Email |
ranjanasure@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ranjana Sure |
| Address |
Ranjana Sure
Senior resident
3rd floor Faculty Building
Department of Neuroanaesthesia and Neurocrtical care
NIMHANS
Hosur Main Road
Bengaluru Karnataka 560029
India
|
| Type of Sponsor |
Other [Self sponsered] |
|
|
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 |
| DrRanjana Sure |
National Institute of Mental Health and Neurosciences |
3rd Floor Faculty Building
Department of Neuroanaesthesia and Neurocritical care
Neurocentre
NIMHANS
Hosur Road/Marigowda Road (Lakkasandra, Wilson Garden)
Bengaluru 560029
Bangalore
KARNATAKA |
8861680105
ranjanasure@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Mental Health and Neurosciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M498||Spondylopathy in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA physical status I–III.
2 Scheduled for elective spine surgery under general anaesthesia.
3 Written informed consent obtained.
|
|
| ExclusionCriteria |
| Details |
1 Pre-existing ocular pathology (example glaucoma, prior intraocular surgery, anisocoria).
2 Neurological disease affecting pupillary function..
3 Chronic opioid therapy (more than 3 months).
4 Psychiatric illness interfering with pain reporting.
5 Patients refusing participation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the association between perioperative pupillometry changes (delta pupillometry is equal to post-operative minus pre-operative pupillometry values) and the total intra-operative opioid dose titrated using Analgesia Nociception Index (ANI) in patients undergoing spine surgery. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To evaluate whether baseline (pre-operative) pupillometry values are predictive of intra operative opioid requirements. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/12/2025 |
| 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="0"
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
|
Pupil size reflects the balance between sympathetic and
parasympathetic systems. Nociceptive stimulation increases
sympathetic discharge which in turn dilates pupil and increases pupillary size
that is inhibited by opioids in dose dependent fashion. The pupil
diameter increases in response to pain regardless of gender and anxiety level. Clinically measured pupillary
size is subjective and has interobserver variability . Hence hand held
pupillometer is used. More the pupillary size more the analgesics required in
intraoperative period to manage pain.
The aim of this study is to evaluate the association
between perioperative pupillometry changes (delta pupillometry is equal to post-operative minus pre-operative pupillometry values) and the total dose
of intra-operative opioids and
perioperative analgesics[ opioid and non opioid] |