| CTRI Number |
CTRI/2025/01/078949 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare spinal anesthesia technique using preprocedural ultrasound guidance versus landmark guidance : A Randomized study |
|
Scientific Title of Study
|
A Comparative study between Preprocedural Ultrasound
guided Versus Landmark-Guided Spinal Anesthesia
technique in Geriatric Patients: A Randomized 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 |
Athota Sushma Therissa |
| Designation |
Junior resident |
| Affiliation |
Government Institute Of Medical Sciences |
| Address |
1st floor, OT complex
GIMS, Greater Noida
201310.
Gautam Buddha Nagar
UTTAR PRADESH
201312
India |
| Phone |
8978422069 |
| Fax |
|
| Email |
bablyathota@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nazia Nazir |
| Designation |
Professor and Head of department |
| Affiliation |
Government Institute Of Medical Sciences |
| Address |
1st floor, OT complex
GIMS, Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9560102957 |
| Fax |
|
| Email |
nazunazir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Athota Sushma Therissa |
| Designation |
Junior Resident |
| Affiliation |
Government Institute Of Medical Sciences |
| Address |
1st floor, OT complex
GIMS, Greater Noida
201310.
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8978422069 |
| Fax |
|
| Email |
bablyathota@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences, Greater Noida, Gautam Buddh Nagar, Uttarpradesh, 201310. |
|
|
Primary Sponsor
|
| Name |
Government Institute Of Medical Sciences |
| Address |
1st floor Main OT complex, Government institute of medical sciences, Greater Noida ,Gautam Budh Nagar,Uttar Pradesh 201310. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Athota Sushma Therissa |
Government Institute Of Medical Sciences |
Main OT complex, 1st floor, GIMS, Greater Noida,Gautam Budh Nagar, Uttar Pradesh,201310.
Gautam Buddha Nagar
UTTAR PRADESH |
8978422069
bablyathota@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GIMS/IEC/HR/2023/11 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z409||Encounter for prophylactic surgery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Preprocedural landmark guded spinal anesthesia technique in geriatric patients |
spinal anesthesia is performed using the conventional landmark palpation technique and midline approach. |
| Intervention |
Preprocedural Ultrasound guided spinal anesthesia in geriatric patients |
Spinal anesthesia is performed using ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
The American Society of Anaesthesiologists (ASA) status I-III patients between the ages of 60-90 years scheduled for surgery under spinal anaesthesia will be included in the study.
|
|
| ExclusionCriteria |
| Details |
The patients with contraindications to spinal anaesthesia, coagulopathy, local anaesthetic allergy, infections in the intervention area, severe stenotic heart disease, and high intracranial pressure and those refusing to participate and having difficulty in cooperating will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective of our study is
1. To assess the rate of successful access to the subarachnoid space on the initial needle insertion attempt by preprocedural ultrasound method.
2. To assess the rate of successful access to the subarachnoid space on the initial needle insertion attempt by preprocedural landmark guided method.
3. To compare the rate of successful access to the subarachnoid space on the initial needle insertion attempt by the two method
|
0 minute,1 minute ,3minute. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objectives include the following features:
the number of needle insertion attempts and needle redirections, time taken to establish landmarks, total procedure time (defined as the sum of time taken to establish the landmarks and time taken to administer spinal anesthesia, needle pain score, patient satisfaction, and the complications related to spinal anesthesia
|
0 minute,1 minute ,2minute. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 3 |
|
Date of First Enrollment (India)
|
28/01/2025 |
| 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
|
| Spinal anesthesia is relatively more difficult in both elderly patients and those with abnormal anatomical landmarks. The preprocedural ultrasound increases the rate of successful access to subarachnoid space at the first attempt in the elderly patients with difficult anatomy. Preprocedural USG reduces the number of needle redirections to achieve successful spinal anesthesia in elderly patients with difficult anatomy. The preprocedural usg did not prolong the spinal anesthesia procedure time in the elderly patients with difficult anatomy. | |