The effect of intraoperative dexmedetomidine infusion administration on optic nerve sheath diameter in patients undergoing spinal surgery in prone position.

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. - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096376

Enrollment

Registered

2025-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: Patients fulfilling American Society of Anesthesiologists (ASA) physical status I- II patients.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Mean difference in optic nerve sheath diameter 30 minutes after establishment of prone position.Timepoint: 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.	—

Measure

Time frame

Mean difference in optic nerve sheath diameter 30 minutes after establishment of prone position.Timepoint: 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.

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Secondary

Measure	Time frame
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.Timepoint: 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.Timepoint: After completion of the surgery and last optic nerve sheath diameter reading.;Mean difference in airway pressures.Timepoint: 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)Timepoint: 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).Timepoint: 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.	—

Measure

Time frame

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.Timepoint: 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.Timepoint: After completion of the surgery and last optic nerve sheath diameter reading.;Mean difference in airway pressures.Timepoint: 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)Timepoint: 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).Timepoint: 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.

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Countries

India

Contacts

Public ContactDr Purva

Maulana Azad Medical College, New Delhi

drbhartitaneja@gmail.com9968604221

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026