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Completed

NCT Number: NCT06872944

Effect of Melatonin on Postoperative Pain After Simple Nephrectomy

The aim of the study is to evaluate the role of melatonin in the management of postoperative pain in patients undergoing simple nephrectomy regarding:

* Pain score (VAS). * Total Morphine consumption is 1st 24 hr. * Time to the 1st rescue analgesia. * Intra-operative and post-operative hemodynamics. * Anxiety. * Patient satisfaction. * Adverse events.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Medicine- Cairo University, Cairo, Egypt

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About this study

This study will be conducted in Cairo University Hospitals at Uorolgy OR. This study will include 40 patients divided into two groups, aged 18 to 65 years, both sexes, belonging to the American Society of Anesthesiologists (ASA) physical status I, II undergoing simple nephrectomy.

  • Inclusion criteria
  • Age from 18 to 65 years.
  • Both sexes.
  • (ASA) physical status I, II.
  • Patients undergoing simple nephrectomy.
  • Exclusion criteria
  • Patient refusal.
  • Patients with a history of allergic reactions to melatonin.
  • Patients receiving drugs with known analgesic and sedative properties.
  • Body Mass Index (BMI) over 30 kg/m2.
  • Drug or alcohol abuse.
  • History of cardiovascular disease.
  • Renal Failure.
  • Mental impairment.
  • Renal impairment.

Medical and surgical history of the patients will be taken, clinical examination of the patients will be performed and routine laboratory investigations as CBC, coagulation studies, renal function and liver function will be done.

Preoperative visit will be conducted the day before surgery. All patients will be evaluated by the same anesthesia resident, who provided information on the preoperative course and instructed them on the procedure.

Each patient will be instructed about postoperative pain assessment with the visual analog scale (VAS) which [0 represents "no pain" while 10 represents "the worst pain imaginable"] and level of anxiety.

Intraoperative management All patients will be connected to standard monitoring which include electrocardiography (ECG), non-invasive arterial blood pressure (NIBP), pulse oximetry, temperature probe, and capnography (will be connected after induction of general anesthesia).

Induction of general anesthesia will be done after inserting 20G venous cannula by IV propofol 2-2.5 mg / kg and IV fentanyl 2ug / kg. After IV Atracurium 0.5mg / kg, endotracheal intubation will be done.

Maintenance of anesthesia will be isoflurane (1-1.5%) with 50-100% oxygen. Incremental doses of IV Atracurium 0.1mg/Kg will be given every 20 min. Patients will be mechanically ventilated and end-tidal CO2 will be maintained between 35-45 mmHg.

Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).

At the end of the surgery, inhalational anesthetics will be stopped waiting for motor power and conscious level to be regained. Then the reversal will be given IV Neostigmine 0.03-0.07 mg/kg + Atropine 0.02 mg/kg.

A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia.

Rescue analgesia of morphine will be given as 3 mg bolus if the VAS > 3 to be repeated after 30 min if pain persists until the VAS < 4. VAS will be assessed at 0, 2, 4, 6, 8, 12, 18, and 24 h postoperatively. The adverse effects will be assessed: hypotension (decrease in basal mean arterial blood pressure by 20%) will be treated with I.V. fluid, bradycardia (defined by decrease in basal heart rate by 20%) will be treated by I.V. atropine 0.02 mg/kg, respiratory depression (the SpO2 < 95% and need O2 supplementation), and 4 mg of ondansetron every 6 hours will be administered for postoperative nausea/vomiting (PONV) as required.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 65 years.
  • Both sexes.
  • (ASA) physical status I, II.
  • Patients undergoing simple nephrectomy.

Exclusion criteria

  • Patient refusal.
  • Patients with a history of allergic reactions to melatonin.
  • Patients receiving drugs with known analgesic and sedative properties.
  • Body Mass Index (BMI) over 30 kg/m2.
  • Drug or alcohol abuse.
  • History of cardiovascular disease.
  • Renal Failure.
  • Mental impairment.
  • Renal impairment.

Treatment and study plan

Melatonin

Drug

Melatonin, or N-acetylmethoxytryptamine, is a hormone secreted by the pineal gland in the brain. Light is the main factor that regulates melatonin production. Melatonin has important biological effects on the body and plays an important role in regulating the sleep wake cycle. Besides circadian rhythm stabilizing, exogenous melatonin has been investigated for other effects such as modulation of blood pressure, body temperature and cortisol control, immune function, and anti-oxidative defense.

Recent studies showed some benefits of perioperative short-acting melatonin in different groups of patients such as quality of recovery after surgery, diminished depressive symptoms and pain score reduction

Sugar Coated Tablet

Drug

sugar coated tablets will be given to the patients at the night (8 PM) before the procedure and another dose 2 hours before surgery

Other names: placebo

Primary outcomes

  1. Pain score (VAS) at 24 h postoperatively

    Time frame: 24 hours postoperative

    A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia.

    Rescue analgesia of morphine will be given as 3 mg bolus if the VAS > 3 to be repeated after 30 min if pain persists until the VAS < 4. VAS will be assessed at 0, 2, 4, 6, 8, 12, 18, and 24 h postoperatively.

Secondary outcomes

  1. Time to the 1st rescue analgesia

    Time frame: (time from end of surgery to first dose of morphine administrated 24 hours postoperative.

    (time passed from end of the surgery till the patient require the first dose of morphine

  2. Total Morphine consumption is 1st 24 hr (mg).

    Time frame: 24 hours postoperative

    total amount of morphine consumed by the patient in first 24 hours postoperative

  3. Degree of patient satisfaction

    Time frame: 24 hours postoperative

    Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Melatonin on Postoperative Pain After Simple Nephrectomy: A Randomized Double-Blinded Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.