A clinical trial to evaluate the effect of different speed of normal saline injection into thoracic epidural space on optic nerve sheath diameter.

A prospective randomised study to evaluate and compare the effect of different rate of normal saline injection into thoracic epidural space on Optic Nerve Sheath Diameter (ONSD). - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060558

Enrollment

Registered

2023-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: Normal saline: Patients will be randomised to receive 10 ml of normal saline into epidural space at a fast speed of 10ml/1 min (group F). For duration of 12 months Control Interventio

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with American society of anaesthesiologists Grade 1, and 2. 2.Age of patients in between 18- 60 years. 3. Patients requiring placement of thoracic epidural at (T5-6 or T6-7) for intraoperative and post operative analgesia in cardiothoracic surgeries (lobectomy, pneumonectomy, decortication, mediastinal mass excision)

Exclusion criteria

Exclusion criteria: 1.Consent not being given. 2- Contraindications to placement of epidural catheter (e.g. Coagulation defect, infection at the site of epidural infection) 3.Patients with history of raised intracranial tension or prior eye injury 4.Pregnant women. 5.Patients with Spinal Deformities. 6.Previous surgical procedures in the eye or CSF diversion procedures. 7.Patients who have evidence of bilateral optic nerve atrophy (blindness).

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of different speed ( at 10ml/1min and at 10ml/2min) of normal saline injection into thoracic epidural space on optic nerve sheath diameter in awake patients.Timepoint: The ONSD reading will be taken at baseline before injection of normal saline(T0), immediately after injection of normal saline (T1), 10 minutes after injection of normal saline(T10), 20 minutes after injection of normal saline (T20).	—

Measure

Time frame

To evaluate the effect of different speed ( at 10ml/1min and at 10ml/2min) of normal saline injection into thoracic epidural space on optic nerve sheath diameter in awake patients.Timepoint: The ONSD reading will be taken at baseline before injection of normal saline(T0), immediately after injection of normal saline (T1), 10 minutes after injection of normal saline(T10), 20 minutes after injection of normal saline (T20).

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Secondary

Measure	Time frame
1. Compare the effect of slow versus fast injection rate of normal saline on Optic nerve sheath diameter at various time points. 2. To study the effect of Epidural saline injection on Heart Rate and Blood Pressure.Timepoint: The ONSD reading will be taken at baseline before injection of normal saline(T0), immediately after injection of normal saline (T1), 10 minutes after injection of normal saline(T10), 20 minutes after injection of normal saline (T20).	—

Measure

Time frame

1. Compare the effect of slow versus fast injection rate of normal saline on Optic nerve sheath diameter at various time points. 2. To study the effect of Epidural saline injection on Heart Rate and Blood Pressure.Timepoint: The ONSD reading will be taken at baseline before injection of normal saline(T0), immediately after injection of normal saline (T1), 10 minutes after injection of normal saline(T10), 20 minutes after injection of normal saline (T20).

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Countries

India

Contacts

Public ContactNannagari Mahesh

Nizams institute of medical sciences

prachikar@yahoo.co.in7702897765

Outcome results

None listed

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