| CTRI Number |
CTRI/2023/12/060558 [Registered on: 20/12/2023] Trial Registered Prospectively |
| Last Modified On: |
06/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to evaluate the effect of different speed of normal saline injection into thoracic epidural space on optic nerve sheath diameter. |
|
Scientific Title of Study
|
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). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NiL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nannagari Mahesh |
| Designation |
Junior resident (MD) |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Department of Anesthesiology and Intensive care, Nizams Institute
of Medical Sciences, Panjagutta, Hyderabad
Panjagutta, Hyderabad, Telangana-500082
Hyderabad
TELANGANA
500082
India |
| Phone |
9948113012 |
| Fax |
|
| Email |
nannagari.mahesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prachi Kar |
| Designation |
Additional professor |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Department of Anesthesiology and Intensive care, Nizams Institute
of Medical Sciences, Panjagutta, Hyderabad,
Hyderabad
TELANGANA
500082
India |
| Phone |
7702897765 |
| Fax |
|
| Email |
prachikar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nannagari Mahesh |
| Designation |
Junior resident (MD) |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Department of Anesthesiology and Intensive care, Nizams Institute
of Medical Sciences, Panjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9948113012 |
| Fax |
|
| Email |
nannagari.mahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, 500082 |
|
|
Primary Sponsor
|
| Name |
Nannagari Mahesh |
| Address |
Junior resident (MD),Department of anesthesiology and intensive
care, Nizams institute of medical sciences, panjagutta, hyderabad,
telangana 500082.Ph.no: 9948113012, nannagari.mahesh@gmail.com |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Nannagari Mahesh |
Nizams institute of medical sciences |
Department of
Anesthesiology and
Intensive care,Panjagutta
Hyderabad
TELANGANA |
9948113012
nannagari.mahesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nims institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 |
| Comparator Agent |
Normal saline |
Patients will be randomised to recieve 10ml of normal saline into epidural space at slow speed of 10ml/2min (Group S).For duration of 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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) |
|
| ExclusionCriteria |
| Details |
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). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
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). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
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). |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
20/12/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
ICP can be measured directly in the ventricle or brain parenchyma. However, such direct measurement is invasive. Optic nerve sheath diameter (ONSD) measurement by ultrasonography is one of the non-invasive methods for ICP assessment. Increasing evidence suggests that ONSD correlates well with the degree of ICP and can detect intracranial hypertension. Epidural injections have also been shown to increase the intracranial pressure (ICP) at least transiently. Both ICP and epidural pressures have been shown to reach peak pressure just after epidural injection and begin to decline thereafter. Few earlier studies have tried to corelate ONSD (as a surrogate marker of ICP) with volume of injectate into epidural space. Previous studies have shown that higher local anaesthetic volume injection into epidural space causes reduction in cerebral blood flow and regional oxygen saturation in infants due to increase in ICP. A sudden increase in epidural pressure is transmitted to the subarachnoid space, to the optic Nerve sheath, causing a compression of the optic nerve and its vasculature. However, literature relating speed of injection into thoracic epidural space and ONSD is scarce. Thus, we planned a prospective randomised study to evaluate and compare effect of different rate of Normal saline injection into thoracic epidural space on Optic Nerve Sheath Diameter (ONSD) in awake patients. All the thoracic epidural catheterisation (with 18 G tuohy’s needle) will be done by only single consultant, who have at least 8 years of experience and have placed more than 200 thoracic epidurals. After fixing the catheter, patients will be randomised to receive 10 ml of normal saline into epidural space either at a fast speed of 10ml/1 min (group F) or slow speed of 10ml/2 min (Group S). 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) with help of ultrasound. |