| CTRI Number |
CTRI/2025/07/090234 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Oral Tablet Midodrine for preventing hypotension after spinal anaesthesia |
|
Scientific Title of Study
|
Comparing efficacy of two doses of preoperative oral midodrine for preventing hypotension after spinal anaesthesia during lower limb orthopaedic surgeries 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 |
Beepata Avanthika |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Gorakhpur |
| Address |
First Floor OT Complex Hospital Building Department of Anesthesia
AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
6309854546 |
| Fax |
|
| Email |
beepataavanthika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GANESH RAMAJI NIMJE |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Room No 101 First Floor OT Complex Department of Anesthesia AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9503332784 |
| Fax |
|
| Email |
ganesh.nimje8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GANESH RAMAJI NIMJE |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Room No 101 First Floor OT Complex AIIMS Gorakhpur
AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9503332784 |
| Fax |
|
| Email |
ganesh.nimje8@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Gorakhpur Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 AVANTHIKA BEEPATA |
AIIMS Gorakhpur |
Department of Anesthesia Orthopedic OT Complex Room No 2
Gorakhpur
UTTAR PRADESH |
6309854546
beepataavanthika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, AIIMS Gorakhpur, India |
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 |
Group 1- 5 mg Midodrine |
Preoperative oral midodrine 5mg, administered 120 mins with sips of water before spinal anesthesia |
| Intervention |
Group 2- 10 mg Midodrine |
Preoperative oral midodrine 10mg, administered administered 120 mins with sips of water before spinal anesthesia. |
| Comparator Agent |
Group 3 - Placebo |
Preoperative oral placebo (Multivitamins tablet as it has same appearance as Midodrine tablet with no cardiovascular effect), administered administered 120 mins with sips of water before
spinal anesthesia.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-65 years
Patients scheduled for elective lower limb orthopedic surgery under spinal anesthesia
BMI 35kg per m2
American Society of Anesthesiologists ASA physical status I and II
Willingness to participate and provide written informed consent |
|
| ExclusionCriteria |
| Details |
Contraindications to spinal anesthesia like coagulopathy and infection at the puncture site
Contraindications to midodrine like pheochromocytoma and severe heart disease
Patients with a history of significant cardiovascular disease like heart failure and uncontrolled hypertension
Patients with renal or hepatic impairment
Patients taking medications that may interact with midodrine like alpha-adrenergic agonists and MAO inhibitors
Pregnancy or lactation
Patients with a known allergy to midodrine
|
|
|
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 |
| Incidence of post spinal anesthesia hypotension defined as systolic blood pressure less than ninety mmHg or a decrease of mean arterial pressure more than twenty percent from baseline |
After spinal anesthesia every 2 mins for initial 20 mins then every 5 mins till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of hypotensive episodes
Severity of hypotension after spinal anaesthesia like duration of hypotensive episodes and lowest systolic blood pressure or Mean Arterial Pressure
Total dose of rescue vasopressors required
Changes in hemodynamic parameters like systolic blood pressure diastolic blood pressure and heart rate from baseline
Incidence of bradycardia defined as heart rate less than 50 bpm
Incidence of adverse events like nausea vomiting headache and hypertension
|
Intraoperative and two hours post operative period |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| 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="6"
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
|
Spinal
anesthesia is a form of neuraxial block
Hypotension is the most common complication
Midodrine it is an alpha one agonist drug which is
arteriolar and venous vasocontriction leads to increase in systolic
blood pressure
Previous studies of oral midodrine for prevention of hypotension after
spinal anesthesia it has shown promising
results
Different Studies was done with different dose of oral midodrine and
placebo
In this study we wish to compare two doses of oral midodrine to known
the effective dose in preventing hypotension after spinal anaesthesia with
minimal side effects
It is randomized double blind study |