| CTRI Number |
CTRI/2025/10/096376 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of intraoperative dexmedetomidine infusion administration on optic nerve sheath diameter in patients undergoing spinal surgery in prone position. |
|
Scientific Title of Study
|
Effect of intraoperative dexmedetomidine on optic nerve sheath diameter as a surrogate for intracranial pressure in patients undergoing spinal surgery in prone position: A randomized controlled 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 |
Dr Purva |
| Designation |
Post Graduate 1st year |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Anaesthesiology, Maulana Azad Medical College Campus,
2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi
New Delhi
DELHI
110002
India |
| Phone |
9416220943 |
| Fax |
|
| Email |
purva2441987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Wadhwa |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Anaesthesiology, Maulana Azad Medical College Campus,
2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604221 |
| Fax |
|
| Email |
drbhartitaneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purva |
| Designation |
Post Graduate 1st year |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Anaesthesiology, Maulana Azad Medical College Campus,
2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi
New Delhi
DELHI
110002
India |
| Phone |
9416220943 |
| Fax |
|
| Email |
purva2441987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College, New Delhi |
| Address |
Maulana Azad Medical College Campus,
2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi, 110002 |
| Type of Sponsor |
Government 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 Purva |
Lok Nayak Hospital, New Delhi |
Department of Anaesthesiology, Lok Nayak Hospital, Jawaharlal Nehru Marg,
Maulana Azad Medical College Campus,
Delhi Gate, New Delhi,
Delhi, 110002
New Delhi
DELHI |
9416220943
purva2441987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITAL ETHICS COMMITTEE |
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
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine group |
Patients will be given dexmedetomidine infusion through IV line 0.5 mcg/kg/hour over 10 min after intubation followed by infusion of 0.4 mcg/Kg /hr continuously until skin closure and its effect on the intracranial pressure will be noted intraoperatively using optic nerve sheath diameter as a surrogate marker. |
| Comparator Agent |
Normal saline group |
Patients will be started with normal saline infusion through the IV line at the same rate and this will act as a control group and the effect on intracranial pressure will be noted using optic nerve sheath diameter as a surrogate marker. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling American Society of Anesthesiologists (ASA) physical status I- II patients.
|
|
| ExclusionCriteria |
| Details |
1. Patients with eye trauma or previous eye surgery.
2. Patients with glaucoma and ophthalmic disease other than refraction errors (myopia, hypermetropia).
3. Patient with cardiac conduction defects, significant cardiac disease and HR less than 60 per min.
4. Patients on beta blockers.
5. History of neurological disease and surgery.
6. History of increased intracranial pressure.
7. Severe Hepatic or renal disease
8. History of allergy to therapeutic drugs used in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean difference in optic nerve sheath diameter 30 minutes after establishment of prone position. |
T0 : Baseline (After induction) About 5 minutes after induction, when stabilization of cardiovascular status had been achieved, baseline optic nerve sheath diameter will be measured in the supine position.
T1: 30 minutes after establishment of prone positioning.
T2: One hour after T1
T3: At subsequent one-hour intervals
T4: After return to supine from prone position. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean difference in optic nerve sheath diameter at induction, at one hourly interval after the first reading in prone position and
after return to supine from prone position. |
1. Baseline (After induction) About 5 min after induction, when stabilization of cardiovascular status had
been achieved, baseline optic nerve sheath diameter will be measured in the supine position.
2. One hour after the first reading in prone position.
3. At subsequent one-hour intervals
4. After return to supine from prone position. |
| Association of duration of surgery on optic nerve sheath diameter in prone position. |
After completion of the surgery and last optic nerve sheath diameter reading. |
| Mean difference in airway pressures. |
1. Baseline (After induction) About 5 min after induction, when stabilization of cardiovascular status had
been achieved.
2. 30 minutes after establishment of prone positioning.
3. One hour after the first reading in prone position.
4. At subsequent one-hour intervals
5. After return to supine from prone position. |
| Mean difference in end tidal CO2 (EtCO2) |
1. Baseline (After induction) About 5 min after induction, when stabilization of cardiovascular status had
been achieved.
2. 30 minutes after establishment of prone positioning.
3. One hour after the first reading in prone position.
4. At subsequent one-hour intervals
5. After return to supine from prone position. |
| Mean difference in Mean Arterial Pressure (MAP). |
1. Baseline (After induction) About 5 min after induction, when stabilization of cardiovascular status had
been achieved.
2. 30 minutes after establishment of prone positioning.
3. One hour after the first reading in prone position.
4. At subsequent one-hour intervals
5. After return to supine from prone position. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 1 |
|
Date of First Enrollment (India)
|
06/11/2025 |
| 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
|
Prone positioning increases the intracranial pressure that can be seen by using optic nerve sheath diameter as a surrogate marker. The study will be conducted in 2 groups. Group D will receive dexmedetomidine loading dose followed by maintenance dose during the induction. The other Group N will receive Normal saline infusion that will act as the control group. The induction of anaesthesia will be done as per the standard protocols. The hypothesis of this study is that dexmedetomidine reduces the intracranial pressure that is bound to increase in the prone spinal surgeries. This reduction in intracranial pressure will be measured by measuring the optic nerve sheath diameter. The optic nerve sheath diameter should not increase in the group D. |