| CTRI Number |
CTRI/2025/12/098509 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Fractionated versus Bolus Spinal Anaesthesia in Elderly Surgical Patients |
|
Scientific Title of Study
|
Comparison of Haemodynamics Between Fractionated and Bolus Injection in Spinal Anaesthesia for Elderly Patients: A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohanapriya S |
| Designation |
Post Graduate |
| Affiliation |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
Department of Anaesthesiology SRM Medical College Hospital Potheri Kattankulathur Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7395970888 |
| Fax |
|
| Email |
drmohanapriyavs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkatraman |
| Designation |
Medical Superintendent and Professor |
| Affiliation |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
Department of Anaesthesiology SRM Medical College Hospital Potheri Kattankulathur Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894581455 |
| Fax |
|
| Email |
drvenkat94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkatraman |
| Designation |
Medical Superintentdent and Professor |
| Affiliation |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
Department of Anaesthesiology SRM Medical College Hospital Potheri Kattankulathur Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894581455 |
| Fax |
|
| Email |
drvenkat94@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital And Research Centre
Potheri Kattankulathur Kancheepuram - 603203 |
|
|
Primary Sponsor
|
| Name |
Dr Mohanapriya S |
| Address |
Department of Anaesthesiology SRM Medical College Hospital and Research Centre Potheri Kattankulathur
Kancheepuram 603203 |
| 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 |
| Dr Mohanapriya S |
SRM Medical College Hospital |
Department of ANAESTHESIOLOGY SRM Medical College Hospital Potheri Kattankulathur Kancheepuram Tamilnadu 603203
Kancheepuram
TAMIL NADU |
7395970888
drmohanapriyavs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M844||Pathological fracture, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractionated intrathecal injection of 0.5% hyperbaric bupivacaine with fentanyl |
A total of 3 ml intrathecal anaesthetic solution (2.5 ml of 0.5% hyperbaric bupivacaine + 0.5 ml fentanyl 25 µg) administered in two fractions: 2 ml initially, followed by 1 ml after a 90-second interval with the spinal needle left in situ.
Performed at L3–L4 interspace in sitting position using 25G Quincke needle.monitor till end of surgery upto 24hours upto 24 |
| Comparator Agent |
Single-bolus intrathecal injection of 0.5% hyperbaric bupivacaine with fentanyl |
A single bolus intrathecal injection of 3 ml solution consisting of 2.5 ml of 0.5% hyperbaric bupivacaine and 0.5 ml fentanyl 25 µg, administered at once at the L3–L4 interspace in sitting position using a 25G Quincke needle. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1 Age Above 65 Years
2 ASA Grade I,II,III
3 Patient Consent |
|
| ExclusionCriteria |
| Details |
1 CONTRAINDICATION TO SPINAL ANAESTHESIA
2 CARDIOVASCULAR DISEASES( ISCHEMIC HEART DISEASE)
3 CEREBROVASCULAR DISEASE
4 SPINE TO DEFORMITIES
5 ALLERGY TO STUDY DRUGS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of Hypotension
MAP LESS THAN 65 mmHg OR MORE THAN OR EQUAL TO 20 PERCENTAGE fall from baseline
Incidence of Bradycardia
HR LESS THAN 60 bpm OR MORE THAN 20 PERCENTAGE fall from baseline |
Every 2 minutes for first 10 minutes,Then every 5minutes for next 2 hours and then every 15 minutes for next 4 hours upto 24 hours postoperatively
Every 5 minutes for next 2 hours
Every 15 minutes for next 4 hours
Every 4 hours up to 24 hours postoperatively
Every 2 minutes for first 10 minutes
Every 5 minutes for next 2 hours
Every 15 minutes for next 4 hours
Every 4 hours up to 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 onset of sensory block
time from completion of spinal injection T10 dermatomes
2 onset of motor block
time from completion of spinal injection to achieving modified bromage score 3
3 two segment regression time
time from maximum sensory level attained to regression by two dermatomes
4 maximum sensory level attained
5 total vasopressor requirement
number of IV phenylphrine 20 microgram boluses required
6 block characteristics duration of sensory & motor block & total duration of anaesthesia
7 adverse events & complication nausea vomitting shivering giddiness |
1 continuously assessed immediately after injection until T10 is reached upto end of surgery
2 continuously assessed until bromage 3 is reached intraoperatively
3 assessed periodically regression occurs
4 max sensory level attained every 10mins upto 24 hours
5 from onset of block until the end of surgery
6 intraoperative postoperative period upto 24 hours
7 intraoprative & up to 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/12/2025 |
| 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 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
|
Informed written consent will be taken from all the patients Patients will be randomly divided into 2 group , Group F ( Two third dose (2ml) injected initially 90 sec gap and remaining one third dose(1ml) given and Group B ( 3ml will be given 2.5ml of o.5% hyperbaric bupivacaine with 0.5ml of fentanyl 25 microgram Utilising a computer generated table of random numbers before starting the procedure with concealment by sealed envelope method on the day of surgery , patient shifted onto the operating room and monitor attached . In the both spinal anaesthesia will be performed by anaesthesiologist patient in sitting position at L3-L4 space with using 25 Guage Quincke spinal needle on each group . first 500ml of ringer lactate solution bolus over 30minutes followed by 500ml/hr onflow . If MAP less than 65 mmHg iv fluid 100ml within 10 mins if still reduced then phenylephrine 20 microgram iv will be given ( total dose will documents till MAP become more than 65 mmHg. Data documentation primarily hemodynamics monitoring . every 2mins for first 10 minutes then every 5 minutes for next hours then every 15mins for 4 hours followed by every 4 hours up to 24 hours postoperatively .secondary outcomes as from intraoperatively , onset evaluated by loos of cold sensation ( sensory block ) and onset of motor block by modified Bromage score and two segment regression time. |