| CTRI Number |
CTRI/2026/03/106278 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Dexamethasone injection to prevent low blood pressure after spinal anaesthesia in elderly patients undergoing leg surgery. |
|
Scientific Title of Study
|
To evaluate the efficacy of prophylactic intravenous dexamethasone in attenuating postspinal hypotension in geriatric patients undergoing lower limb orthopaedic surgery- A randomised controlled double blind 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 |
Dr Anju Rani |
| Designation |
Associate Professor |
| Affiliation |
Pt.B.D. Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt.B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9540526120 |
| Fax |
|
| Email |
anjudahiya88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirtika Ojha |
| Designation |
Junior Resident |
| Affiliation |
Pt.B.D. Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt.B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8745002563 |
| Fax |
|
| Email |
aojha2013@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirtika Ojha |
| Designation |
Junior Resident |
| Affiliation |
Pt.B.D. Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt.B.D. Sharma PGIMS Rohtak
HARYANA
124001
India |
| Phone |
8745002563 |
| Fax |
|
| Email |
aojha2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B. D. Sharma PGIMS Rohtak, Haryana |
|
|
Primary Sponsor
|
| Name |
Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Institutional, Pt.B.D. Sharma PGIMS Rohtak 124001 |
| Type of Sponsor |
Government 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 Kirtika Ojha |
Pt. B. D. Sharma PGIMS Rohtak |
Department of Anaesthesiology and critical care, second floor, Modular OT complex, PGIMS Rohtak
Rohtak
HARYANA |
8745002563
aojha2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B.D. Sharma PGIMS/UHS, Rohtak |
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 |
Intravenous Dexamethasone in elderly patients undergoing lower limb orthopedic surgery under spinal anesthesia |
Patients will receive 8 mg dexamethasone diluted in normal saline to a total volume of 5 mL administered intravenously 1 hour prior to spinal anaesthesia.
Purpose:
To evaluate its efficacy in attenuating post-spinal hypotension in geriatric patients undergoing lower limb orthopaedic surgery. |
| Comparator Agent |
Normal Saline (placebo) |
Description:Patients will receive 5 mL normal saline intravenously 1 hour prior to spinal anaesthesia.
Purpose:Serves as placebo control for comparison with dexamethasone group. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to the American Society of Anaesthesiologists-Physical Status I to III and aged 65 years or more of either sex, undergoing lower limb orthopaedic surgery under spinal anaesthesia will be included in the study. |
|
| ExclusionCriteria |
| Details |
The following patients will be excluded from the study:Patients refusing to give consent;Patients having spinal deformity, contraindications to
spinal anesthesia (coagulopathy, thrombocytopenia,
allergy to local anesthetics);Patients with known hypersensitivity to dexamethasone;Patients on chronic corticosteroid therapy, SSRI,
antihypertensive drugs; BMImore than 30 kg per m2; Patients with cardiac diseases. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of post spinal hypotension after giving spinal anaesthesia. Hypotension will be defined as equal to or more than 20 percent decrease in mean arterial pressure from baseline following spinal anaesthesia. |
Heart Rate and Blood Pressure will be recorded before giving subarachnoid injection and then every 5 minutes for 30 minutes immediately after giving spinal anaesthesia and thereafter, every 15 minutes till the end of surgery or till 120 minutes, whichever is later. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Vasopressor requirement
Total dose of ephedrine required to treat hypotension. |
During intraoperative period. |
2. Intravenous fluid requirement
Total volume of intravenous fluid administered intraoperatively. |
During surgery |
3. Incidence of bradycardia
Bradycardia defined as heart rate less than 50 beats per minute requiring atropine |
During intraoperative period |
| 4. Incidence of Nausea, vomiting and shivering following spinal anaesthesia |
During intraoperative period |
| 5. Total blood loss during surgery will be estimated and recorded. |
During intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
28/03/2026 |
| 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
|
Post-spinal hypotension is a common complication following spinal anaesthesia, particularly in elderly patients, due to decreased sympathetic tone and impaired compensatory cardiovascular responses. This may lead to adverse outcomes if not promptly managed. Various preventive strategies including fluid loading and vasopressors have been used; however, these may be associated with undesirable side effects. Dexamethasone, a commonly used corticosteroid, may attenuate spinal-induced hypotension by reducing activation of the Bezold–Jarisch reflex and enhancing vascular responsiveness to vasoconstrictors. This prospective, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy of prophylactic intravenous dexamethasone in reducing the incidence of post-spinal hypotension in geriatric patients undergoing lower limb orthopaedic surgery under spinal anaesthesia. Seventy patients aged 65 years or older will be randomly allocated to receive either intravenous dexamethasone or placebo prior to spinal anaesthesia. Hemodynamic parameters, vasopressor requirement, intravenous fluid administration, and adverse events will be recorded and compared between the two groups. |