| CTRI Number |
CTRI/2025/03/083021 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| 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
|
Effect of making the patient sit for 2 minutes after injection in the back on drop in blood pressure in patients undergoing lower limb surgeries |
|
Scientific Title of Study
|
Effect of Delayed Supine Positioning on Hypotension As Measured By Mean Arterial Pressure In Elderly Patients Undergoing Lower Limb Surgeries- A Randomized Controlled 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 |
Pon Sushma |
| Designation |
Post graduate MD Anaesthesiology |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Room No 208 B Block Dept of Anaesthesiology 2nd Floor SRM Medical College and research hospital Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7357378949 |
| Fax |
|
| Email |
dr.ponsushma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Anand |
| Designation |
Professor |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Room No 208 B Block Dept of Anaesthesiology 2nd Floor SRM Medical College and research hospital Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
anandk@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Anand |
| Designation |
Professor |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Room No 208 B Block Dept of Anaesthesiology 2nd Floor SRM Medical College and research hospital Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
anandk@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College and research hospital Kattangulathur Kanchipuram Tamil Nadu 603203 India |
|
|
Primary Sponsor
|
| Name |
SRM Medical College |
| Address |
Room No 209 B Block Dept of Anesthesiology SRM Medical College and research hospital Kattangulathur Kanchipuram Tamil Nadu |
| Type of Sponsor |
Private medical college |
|
|
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 Pon Sushma |
SRM institute of science and technology |
Room No 209 B Block 2nd floor Dept of Anesthesiology SRM Medical College hospital and research centre Kattangulathur
Kancheepuram
TAMIL NADU |
7357378949
dr.ponsushma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM institutional Ethics Committee students |
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 |
Delayed supine positioning in elderly patients undergoing lower limb surgeries |
making the patient to sit upright for 2 minutes after administering spinal anesthesia in elderly patients undergoing lower limb surgeries |
| Comparator Agent |
Immediate supine positioning post spinal anesthesia in elderly patients undergoing lower limb surgeries |
Making the patient to lie down immediately after administering spinal anesthesia in elederly patients undergoing lower limb surgeries |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All ASA PS I II and III patients undergoing lower limb surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
contraindications to spinal anesthesia like local anesthetic allergy, infection, increased intracranial pressure, preexisting neurological defecit |
|
|
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 |
| incidence of hypotension |
2 4 6 8 10 15 20 25 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Phenylephrine requiremnt |
2 4 6 8 10 15 20 25 30 minutes |
| changes in Heart rate |
2 4 6 8 10 15 20 25 30 minutes |
| incidence of nausea and vomitting |
|
| Time of onset of pain post spinal anesthesia |
|
| Heart rate at the time of first episode of hypotension |
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
31/03/2025 |
| 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
|
We hypothesize that the incidence of hypotension is lower in patients made to sit for 2 minutes post spinal anesthesia in elderly patients undergoing lower limb surgeries, when compared to patients made to lie down immediately after spinal anesthesia. Phenylephrine requirement, changes in heart rate, incidence of nausea and vomitting, time of onset of pain post spinal anesthesia, heart rate at the time of onsset of first episode of hypotension are the secondary outcomes taken into consideration |