| CTRI Number |
CTRI/2026/01/100587 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| 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
|
Testing whether an oral medicine called midodrine can prevent low blood pressure after spinal anesthesia in patients undergoing lower-limb bone surgeries |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL TO DETERMINE THE EFFICACY OF PROPHYLACTIC ORAL MIDODRINE IN PREVENTING POST SPINAL HYPOTENSION IN PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES |
| 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 Kallesh K G |
| Designation |
Post graduate |
| Affiliation |
Karnataka Medical College and Research Institute |
| Address |
206 Department of Anaesthesiology KMCRI Vidyanagar KIMS campus Hubballi Dharwad district Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
8050672377 |
| Fax |
|
| Email |
Kallesh007.kk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavraj Kallapur |
| Designation |
Professor |
| Affiliation |
Karnataka Medical College and Research Institute |
| Address |
206 Department of Anaesthesiology KMCRI Vidyanagar KIMS campus Hubballi Dharwad district Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
6364503729 |
| Fax |
|
| Email |
Doc_basu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kallesh K G |
| Designation |
Post graduate |
| Affiliation |
Karnataka Medical College and Research Institute |
| Address |
206 Department of Anaesthesiology KMCRI Vidyanagar KIMS campus Hubballi Dharwad district Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
8050672377 |
| Fax |
|
| Email |
Kallesh007.kk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Karnataka Medical college and Research Institute |
| Address |
KMCRI Vidyanagar Hubballi Dharwad Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Kallesh K G |
Karnataka Medical College and Research Institute |
201 Department of anaesthesiology KMCRI Vidyanagar Hubbali taluk Dharwad Karnataka 580021
Dharwad
KARNATAKA |
8050672377
Kallesh007.kk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Science Hubballi Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (2) ICD-10 Condition: V99||Unspecified transport accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo tablet |
Single oral dose of placebo tablet identical in appearance to Midodrine, given 1 hour before spinal anaesthesia.
Acts as control arm for comparison of efficacy in preventing post-spinal hypotension. |
| Intervention |
Tablet.Midodrine 10 mg |
Single oral dose of Midodrine Hydrochloride 10 mg given 1 hour before spinal anaesthesia.
Drug administered for prevention of post-spinal hypotension in patients undergoing lower limb orthopaedic surgery. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients aged between 20 to 50 years of either sex undergoing lower limb orthopaedic surgery.
b) ASA 1 and ASA 2 patients.
c) Giving written consent for participating in the study. |
|
| ExclusionCriteria |
| Details |
Patients with
a)Baseline systolic blood pressure more than 140 mm Hg before administration of
oral midodrine.
b)Patients with deranged coagulation profile and on anti-coagulants.
c) Any contraindications to spinal anaesthesia.
d) Medical conditions, which release vasoconstrictors such as
pheochromocytoma and the patients taking vasoconstrictors and
uncorrected tachyarrhythmia |
|
|
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 |
| To compare the incidence of postspinal hypotension between study and placebo group. |
Hemodynamic variables such as
systolic blood pressure and heart rate were recorded at 2, 5, 10, 15, 30, 45 and 60 minutes after spinal anaesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To compare the hemodynamic characteristics (heart rate, mean arterial pressure).
b) Rescue dose of ephedrine used to treat hypotension.
c) Incidence of bradycardia & vasovagal attacks.
d) Reactive hypertension.
e) Nausea, vomiting, & shivering |
1.Hemodynamic parameters at baseline & at 2, 5, 10, 15, 30, 45, 60 minutes after spinal anaesthesia & after tourniquet deflation.
2.Ephedrine use, bradycardia, vasovagal events, reactive hypertension, nausea, vomiting, & shivering are measured intraoperatively |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/01/2026 |
| 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
|
A prospective randomized double blinded comparative study is planned. Pre- anaesthetic evaluation of all patients undergoing lower limb orthopaedic surgery will be performed by an anaesthesiologist a day before surgery. Patients will be kept nil by mouth after midnight and pre medicated with Pantoprazole 40mg orally night before and on the morning of the surgery. An informed, written and valid consent will be taken from 100 patients, who satisfy the inclusion criteria and they will be randomly allocated to two groups according to computer generated randomized number table. Allocation concealment will be done by serially numbered opaque sealed envelope (SNOSE) method. Patients and investigator will be blinded to the study drugs. The study drugs will be administered to patients (Group M and Group P) by anaesthesiologist who will not be taking part in the study. All patients will be screened in the ward before attendance to the theatre by the anaesthesiologist who supervised the administration of tablets. Baseline systolic blood pressure (SBP) and heart rate (HR) are recorded. Patients will be randomly allocated to the following: Group M (n = 50): Midodrine tablets of 10 mg will be given 1 hour before spinal anaesthesia. Group P (n = 50): Placebo tablets (identical to Midodrine tablets) will be given 1 hour before spinal anaesthesia. Intraoperative monitoring includes electrocardiography, non invasive blood pressure, and pulse oximetry. An 18-gauge cannula will be inserted, and 8 mL/kg of lactated ringer’s solution will be given to all patients before performing subarachnoid block. Subarachnoid block will be performed in the sitting position by injecting hyperbaric bupivacaine 15 mg (0.5% hyperbaric bupivacaine 3mL) and 60µg Buprenorphine in L4-5 or L3-4 intervertebral space using a 25-gauge quinke spinal needle. The highest sensory level of the spinal block was tested by the pinprick method, every 5 minutes for 20 minutes and recorded after 20 minutes. Hemodynamic variables such as systolic blood pressure and heart rate were recorded at 2, 5, 10, 15, 30, 45,and 60 minutes after spinal anaesthesia. In addition, these parameters were recorded after deflation of the tourniquet at the end of the surgery. Intraoperative hypotension is defined as decrease in systolic blood pressure to less than 80% of baseline or to less than 90mmHg. It will be treated with 5mg ephedrine IV bolus and increasing infusion rate of lactated ringer’s solution. 5mg ephedrine IV bolus will be repeated if hypotension persists. Severe hypotension (systolic blood pressure less than 80 mm Hg) will be treated with an intravenous bolus of 10mg ephedrine. Symptomatic bradycardia will be treated with intravenous atropine 0.6 mg and repeated if needed. A single measurement of systolic blood pressure or heart rate below the defined level will be sufficient to qualify as hypotension, severe hypotension, and bradycardia. The number of doses of intravenous ephedrine(5mg) and intravenous atropine used to manage intraoperative hypotension and bradycardia will be noted. In the event of episodes of reactive hypertension defined as systolic blood pressure more than 160mmHg will be managed with injection labetalol 5 to 20 mg IV bolus or injection nitroglycerine infusion a the rate of 5 to 20 mcg/kg/min. The primary outcome will be the occurrence of hypotension defined as systolic blood pressure less than 90 mm Hg or less than 80% of baseline, after spinal anaesthesia. Our hypotension outcome is a binary event (yes/no) defined as the occurrence of at least 1 episode for a patient below either threshold, versus none, across the repeated measurements. Secondary outcomes include requirements of ephedrine and atropine, episodes of reactive hypertension (more than 120% of baseline systolic blood pressure), nausea and vomiting, vasovagal attacks, and shivering. |