The effect of oral melatonin before percutaneous nephrolithotomy surgery

The effect of oral melatonin before percutaneous nephrolithotomy (PCNL) on the incidence of SIRS and sepsis and postoperative outcomes and complications: a double-blind randomized clinical trial study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190624043991N26

Enrollment

104

Registered

2024-05-18

Start date

2024-08-26

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Kidney stones. Calculus of lower urinary tract

Interventions

Intervention 1: Intervention group: PCNL treatment group along with melatonin intake. Intervention 2: Control group: PCNL with placebo.

Eligibility

Sex/Gender

All

Age

20 Years to 55 Years

Inclusion criteria

Inclusion criteria: Patients in the age range of 20 to 55 years Candidate for PCNL surgery under general anesthesia Written and informed consent from patients

Exclusion criteria

Exclusion criteria: Neuro-psychiatric diseases such as depression and schizophrenia Heart diseases and brain treatment The use of sedatives and beta blockers and sleeping pills or pain relievers Existence of drug sensitivity Estimated duration of anesthesia>4 hours

Design outcomes

Primary

Measure	Time frame
Changes in the incidence of SIRS caused by percutaneous nephrolithotomy (PCNL) due to the use and non-use of melatonin. Timepoint: 24 to 48 hours after the operation. Method of measurement: Medical laboratory.;Changes in the incidence of sepsis caused by percutaneous nephrolithotomy (PCNL) due to the use and non-use of melatonin. Timepoint: 24 to 48 hours after the operation. Method of measurement: Medical laboratory.	—

Measure

Time frame

Changes in the incidence of SIRS caused by percutaneous nephrolithotomy (PCNL) due to the use and non-use of melatonin. Timepoint: 24 to 48 hours after the operation. Method of measurement: Medical laboratory.;Changes in the incidence of sepsis caused by percutaneous nephrolithotomy (PCNL) due to the use and non-use of melatonin. Timepoint: 24 to 48 hours after the operation. Method of measurement: Medical laboratory.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Akram Mirzaei

Tehran University of Medical Sciences

mirzaee.scholar@gmail.com+98 21 6634 8560

Outcome results

None listed

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