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Hemodynamic instability comparison between prazosin and amlodipine in PPGL(pheochromocytoma and paraganglioma)

Comparative analysis of Pre-operative Prazosin versus Am-lodipine on Intraoperative Hemodynamic Instability in Patients with Pheochromocytoma/Paraganglioma (PPGL): An Open-label Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071431
Enrollment
18
Registered
2024-07-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: E368- Other intraoperative complicationsof endocrine system

Interventions

Intervention1: AMLODIPINE: Tablet Amlodipine will be started at the dosage of 2.5 mg once daily per oral and up-titrated at dose of 2.5 mg increments daily up to 10 mg in two divided doses then in i

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and ResearchJIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age- 18-65 years 2. Secretory PPGL - Elevated plasma-free meta-nephrine and or plasma-free normetanephrine irre-spective of Blood pressure recordings 3. Planned for surgical removal

Exclusion criteria

Exclusion criteria: 1. Bilateral tumour 2. Distant metastasis 3. Pregnancy 4. Incapability to adhere to study protocol

Design outcomes

Primary

MeasureTime frame
To determine the efficacy of amlodipine in reducing the intra-operative hemodynamic instability duration (%) in patients with PPGL compared to prazosinTimepoint: At the end of surgery

Secondary

MeasureTime frame
To determine the efficacy of amlodipine in reducing the intraoperative hemodynamic instability score in patients with PPGL compared to prazosin To study Ambulatory blood pressure monitoring (ABPM ) characteristics pre-operatively & hemo-dynamic instability post-operatively in patients with PPGL To identify the factors influencing hemodynamic in-stability during the peri-operative period Timepoint: At the end of 24 hours after surgery

Countries

India

Contacts

Public ContactSadishkumar kamalanathan

Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),PONDICHERRY

sadishkk@gmail.com9629528518

Outcome results

None listed

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