| CTRI Number |
CTRI/2025/11/098217 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Preventing blood pressure drops in elderly patients after spinal anaesthesia with tablet midodrine. |
|
Scientific Title of Study
|
Oral midodrine for preventing post-spinal anaesthesia hypotension in elderly: 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 Tarun Yadav |
| Designation |
Professor |
| Affiliation |
Pt BDS PGIMS Rohtak |
| Address |
Department of Anaesthesiology, Room number 25, Second Floor, New OT Complex, Pt BDS PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8826444011 |
| Fax |
|
| Email |
drtarunyadav@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarun Yadav |
| Designation |
Professor |
| Affiliation |
Pt BDS PGIMS Rohtak |
| Address |
Department of Anaesthesiology, Room number 25, Second Floor, New OT Complex, Pt BDS PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8826444011 |
| Fax |
|
| Email |
drtarunyadav@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep kumar |
| Designation |
Junior Resident |
| Affiliation |
Pt BDS PGIMS , Rohtak |
| Address |
Department of Anaesthesiology, room no 25, second floor, new OT complex, Pt BDS PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9818096332 |
| Fax |
|
| Email |
s9818096332kumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Haryana
Pandit Bhagwat Dayal Sharma post graduate institute of medical sciences. |
|
|
Primary Sponsor
|
| Name |
Government of Haryana, Pt BDS PGIMS, Rohtak, Haryana |
| Address |
PGIMS campus, Rohtak, Haryana, 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 Tarun Yadav |
Pt BDS PGIMS Rohtak |
Department of Anaesthesiology, Room number 25, Second Floor, New OT Complex, Pt BDS PGIMS Rohtak
Rohtak
HARYANA |
08826444011
drtarunyadav@yahoo.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 |
Oral tab Midodrine |
Group A - Who will receive oral tab Midodrine 5mg, 90mins before spinal anaesthesia |
| Comparator Agent |
Oral tab Thiamine |
Group B - Who will receive oral tab Thiamine 100mg, 90mins before spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 60 years or older of either sex, belonging to ASA physical status I-II scheduled for below umbilical surgery under spinal anaesthesia will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with: spinal deformity, uncontrolled hypertension and diabetes, cardiac diseases, history of glaucoma, refusal to participate, non-compliance, liver disease and renal impairment, hyperthyroidism, anticipated surgical duration more than 120 mins. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence post spinal anaesthesia hypotension with use of prophylactic oral midodrine vs placebo. |
Post spinal anaesthesia at 0, 2,4,6,8,10,15,20,25,30,35,40,45,60,75,90,105 and 120 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare total volume of IV fluid infused in both group.
2.To compare intraoperative ephedrine consumption in both group.
3.To assess incidence of other complications like- bradycardia, hypertension, shivering, nausea, vomiting, flushing, pruritis in both group. |
At end of surgery.
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/12/2025 |
| 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) |
Open to Recruitment |
|
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
|
Title: Oral midodrine for preventing post- spinal anaesthesia hypotension in elderly: A randomized controlled trial. Aim: To evaluate the efficacy of oral midodrine as prophylaxis against post- spinal hypotension. Primary objective: To compare the incidence of post spinal anaesthesia hypotension with use of prophylactic oral midodrine versus placebo. Secondary Objectives: • To compare total volume of intravenous fluid infused in both group. • To compare intraoperative ephedrine consumption in both group. • To assess incidence of other complications like– bradycardia, pruritis, flushing, hypertension, shivering, nausea, vomiting etc in both group. Inclusion criteria:- Adult patients aged 60 years or older of either sex, belonging to ASA Physical status I-II scheduled for below umbilical surgery under spinal anaesthesia will be included in the study. Exclusion criteria:- Patients with
• BMI> 30 kg/m2, • Height < 130 cm, • Spinal deformity, • Uncontrolled Hypertension and Uncontrolled diabetes, • Patients with Cardiac diseases, • History of glaucoma, • Liver disease and renal impairment, • Contraindications of spinal anesthesia, • Anticipated surgical duration more than 120 mins. • Non-compliance, • Refusal to participate. • Hyperthyroidism. Sample size: 80 patients (40 in each group) Group allocation: Group midodrine(n=40) will receive oral tab midodrine 5mg, 90mins before spinal anaesthesia. Group control(n=40) will receive oral tab thiamine 100mg, 90mins before spinal anaesthesia. Assessment: 1. Incidence of post spinal anaesthesia hypotension. 2.Total volume of IV fluid infused. . 3. Intraoperative ephedrine consumption. . 4. Incidence of other complications Analysis: Data will be compiled, and appropriate statistical test will be applied for the result.. |