| CTRI Number |
CTRI/2023/01/048666 [Registered on: 02/01/2023] Trial Registered Prospectively |
| Last Modified On: |
31/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
spinal anaesthesia in old person while under constant ultrasound view vs marking point of entry of spinal by ultrasound |
|
Scientific Title of Study
|
A Comparative Study of Real Time Ultrasound-Guided Spinal Anaesthesia With Ultrasound-Assissted Spinal Anaesthesia In Geriatric Patients: A Randomized Controlled Trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swarnika Singh |
| Designation |
senior resident |
| Affiliation |
indira gandhi institute of medical sciences , Patna |
| Address |
Department of anaesthesiology, 1st floor, ward block, IGIMS, sheikhpura, Patna, Bihar
Patna
BIHAR
800014
India |
| Phone |
8420445989 |
| Fax |
|
| Email |
swarnika001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati |
| Designation |
additional professor |
| Affiliation |
indira gandhi institute of medical sciences |
| Address |
Department of anaesthesiology, 1st floor, ward block, IGIMS, sheikhpura, Patna, Bihar
Patna
BIHAR
800014
India |
| Phone |
9113463130 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati |
| Designation |
additional professor |
| Affiliation |
indira gandhi institute of medical sciences |
| Address |
Department of anaesthesiology, 1st floor, ward block, IGIMS, sheikhpura, Patna, Bihar
Patna
BIHAR
800014
India |
| Phone |
9113463130 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| indira gandhi institute of medical sciences, Patna |
|
|
Primary Sponsor
|
| Name |
swarnika singh |
| Address |
Department of anaesthesiology, 1st floor, ward block, IGIMS,Sheikhpura, Patna, Bihar |
| 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 |
| swarnika singh |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, PATNA |
Department of anaesthesiology, 1st floor, ward block, IGIMS, Patna, Bihar
Patna
BIHAR |
8420445989
swarnika001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| indira gandhi institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
real time ultrasound guided spinal anaesthesia |
in real time ultrasound guided spinal anaesthesia, under ultrasound view, spinal space will be reached. the duration of intervention will be 15min. |
| Comparator Agent |
ultrasound assissted spinal anaesthesia |
ultrasound assissted spinal anaesthesia, entry point will be marked with ultrasound and space will be reaches through this entry point.the duration of intervention will be 15minutes |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective surgery with spinal anesthesia
≥65 years of age
American Society of Anesthesiologists (ASA) physical status I to III
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with severe cardiopulmonary diseases
Contraindications of spinal anesthesia (eg, coagulopathy, puncture site infection, or local anesthetics allergy)
Inability to communicate and cooperate were excluded
|
|
|
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 |
| First-attempt success rate of spinal anesthesia, with “first-attempt†defined as the needle achieving successful dural puncture through a single attempt. |
0min,5min,10min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts
First-pass success rate
Number of passes
Locating time
Procedure time
Total time
Adverse reactions
Patient satisfaction score
Procedural difficulty score
|
0 hrs, 2hrs, 4hrs |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
in geriatric patients, spinal anaesthesia will be given under ultrasound guidance via 2 technique, real time ultrasound guided and ultrasound assissted. we will assess which technique is better, as spinal is difficult in this subset of population. |