Oral Tablet Midodrine for preventing hypotension after spinal anaesthesia

Comparing efficacy of two doses of preoperative oral midodrine for preventing hypotension after spinal anaesthesia during lower limb orthopaedic surgeries A Randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090234

Enrollment

126

Registered

2025-07-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Group 1- 5 mg Midodrine: Preoperative oral midodrine 5mg, administered 120 mins with sips of water before spinal anesthesia Intervention2: Group 2- 10 mg Midodrine: Preoperative oral mi

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 baselineTimepoint: After spinal anesthesia every 2 mins for initial 20 mins then every 5 mins till end of surgery	—

Secondary

Measure	Time frame
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 Timepoint: Intraoperative and two hours post operative period	—

Measure

Time frame

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 Timepoint: Intraoperative and two hours post operative period

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Countries

India

Contacts

Public ContactDr GANESH RAMAJI NIMJE

AIIMS Gorakhpur

ganesh.nimje8@gmail.com9503332784

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026