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Intraoperative Controlled Hypotension during Percutaneous Nephrolithotomy

Investigating the Effect of Intraoperative Controlled Hypotension on Bleeding Rate and Percutaneous Nephrolithotomy Outcomes for Simple Renal Caliceal Stones

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231020059776N2
Enrollment
60
Registered
2025-10-23
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Simple Renal Caliceal Stones. Calculus of kidney

Interventions

Intervention 1: Intervention group: Controlled hypotensive anesthesia will be induced by injection of 5 mg/mL Labetalol dissolved in 0.9% normal saline to maintain MAP at approximately 60 mmHg. Interv

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 60 years Patients with functionally healthy kidneys Patients with simple renal caliceal stones candidate for PCNL surgery Patients who agree to participate in this trial will provide written informed consent.

Exclusion criteria

Exclusion criteria: Age above 60 years Patients reported a history of hypertension, obstructive pulmonary disease, chronickidney disease, liver disease, cardiovascular disease (especially severe sinusbradycardia), and patients with high creatinine levels Patients reported a history of diabetes mellitus, major neurologic conditions such asstroke or multiple sclerosis, and cardiovascular problems such as heart failure. Patients with large and complex stones. Not eligible to participate in this trial as a decision of the researchers

Design outcomes

Primary

MeasureTime frame
Operative blood loss. Timepoint: During PCNL surgery. Method of measurement: Operative blood loss was calculated by the volume of blood recovered from the suction bottle and visual estimation from the sponge and lap counts.;Hematocrit drop. Timepoint: Before and after PCNL surgery. Method of measurement: Using measurement in patient lab testing.

Secondary

MeasureTime frame
Operative time. Timepoint: From the beginning of the needle to the kidney until the end of the operation. Method of measurement: Record by minutes.;Stone free rate. Timepoint: Before and after PCNL surgery. Method of measurement: CT scan.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Masjedi

Shiraz University of Medical Sciences

masjedi_f@sums.ac.ir+98 71 3628 1528

Outcome results

None listed

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