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

Phase 2

• Conditions: Health Condition 1: 4- Measurement and Monitoring

• Registration Number: CTRI/2023/12/060558
• Lead Sponsor: annagari Mahesh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of different speed ( at 10ml/1min and at 10ml/2min) of normal saline <br/ ><br>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 <br/ ><br>normal saline(T0), immediately after injection of normal saline (T1), 10 minutes <br/ ><br>after injection of normal saline(T10), 20 minutes after injection of normal saline <br/ ><br>(T20).

Secondary Outcome Measures

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