Testing whether an oral medicine called midodrine can prevent low blood pressure after spinal anesthesia in patients undergoing lower-limb bone surgeries

A RANDOMIZED CONTROLLED TRIAL TO DETERMINE THE EFFICACY OF PROPHYLACTIC ORAL MIDODRINE IN PREVENTING POST SPINAL HYPOTENSION IN PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100587

Enrollment

100

Registered

2026-01-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified Health Condition 2: V99- Unspecified transport accident

Interventions

Intervention1: 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 patient

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To compare the incidence of postspinal hypotension between study and placebo group.Timepoint: 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

Measure	Time frame
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, & shiveringTimepoint: 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	—

Measure

Time frame

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, & shiveringTimepoint: 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

—

Countries

India

Contacts

Public ContactDr Kallesh K G

Karnataka Medical College and Research Institute

Doc_basu@yahoo.co.in6364503729

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026