Effect of Melatonin on Postoperative Pain After Simple Nephrectomy
NCT ID: NCT06872944
Last Updated: 2025-07-14
Study Results
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Basic Information
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COMPLETED
EARLY_PHASE1
40 participants
INTERVENTIONAL
2025-03-21
2025-07-07
Brief Summary
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* 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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Detailed Description
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1. Inclusion criteria
* Age from 18 to 65 years.
* Both sexes.
* (ASA) physical status I, II.
* Patients undergoing simple nephrectomy.
2. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group M
Patients will receive 4 mg of prolonged-release formulation of oral melatonin at the night (8 PM) before the procedure and another dose 2 hours before surgery.
Melatonin
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
Group C
Patients will receive sugar coated tablets at the night (8 PM) before the procedure and another dose 2 hours before surgery.
Sugar Coated Tablet
sugar coated tablets will be given to the patients at the night (8 PM) before the procedure and another dose 2 hours before surgery
Interventions
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Melatonin
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both sexes.
* (ASA) physical status I, II.
* Patients undergoing simple nephrectomy.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Karim Hussein
lecturer of anesthesia-faculty of medicine
Locations
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Faculty of Medicine-Cairo Univeristy
Cairo, , Egypt
Faculty of Medicine- Cairo University
Cairo, , Egypt
Countries
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References
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Bonmati-Carrion MA, Rol MA. Melatonin as a Mediator of the Gut Microbiota-Host Interaction: Implications for Health and Disease. Antioxidants (Basel). 2023 Dec 23;13(1):34. doi: 10.3390/antiox13010034.
Kiabi FH, Emadi SA, Jamkhaneh AE, Aezzi G, Ahmadi NS. Effects of preoperative melatonin on postoperative pain following cesarean section: A randomized clinical trial. Ann Med Surg (Lond). 2021 May 12;66:102345. doi: 10.1016/j.amsu.2021.102345. eCollection 2021 Jun.
Andersen LP. The analgesic effects of exogenous melatonin in humans. Dan Med J. 2016 Oct;63(10):B5289.
Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
Chen Q, Beal EW, Okunrintemi V, Cerier E, Paredes A, Sun S, Olsen G, Pawlik TM. The Association Between Patient Satisfaction and Patient-Reported Health Outcomes. J Patient Exp. 2019 Sep;6(3):201-209. doi: 10.1177/2374373518795414. Epub 2018 Aug 27.
Other Identifiers
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melatonin in nephrectomy
Identifier Type: -
Identifier Source: org_study_id
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