Melatonin ameliorates inflammation and improves outcomes of ischemia/reperfusion injury in patients undergoing coronary artery bypass grafting surgery: a randomized placebo-controlled study.
Study Goal
To investigate whether high-dose melatonin protects against myocardial ischemia-reperfusion injury and inflammation in patients undergoing on-pump CABG surgery.
Results Summary
Melatonin reduced inflammatory biomarkers (TNF-α, NF-κB, IL-6) and cardiac troponins, improved recovery scores, decreased diastolic blood pressure, and shortened intubation time compared to placebo. It was well-tolerated with no reported side effects.
Population
Patients undergoing on-pump coronary artery bypass grafting (CABG) surgery.
Effective Dosage
60 mg/day melatonin capsules.
Duration
5 days before surgery.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
high dose melatonin (60 mg/day) | decrease | TNF-α levels | patients undergoing on-pump coronary artery bypass grafting (CABG) surgery | - | decreased | #1 |
high dose melatonin (60 mg/day) | increase | TNF-α | patients undergoing on-pump coronary artery bypass grafting (CABG) surgery | - | significantly increased in PTG versus MTG | #2 |
high dose melatonin (60 mg/day) | increase | Troponins | patients undergoing on-pump coronary artery bypass grafting (CABG) surgery | - | significantly increased in PTG versus MTG | #3 |
high dose melatonin (60 mg/day) | decrease | NF-κB levels | patients undergoing on-pump coronary artery bypass grafting (CABG) surgery | - | declined | #4 |
high dose melatonin (60 mg/day) | increase | IL-6 | patients undergoing on-pump coronary artery bypass grafting (CABG) surgery | - | significantly increased in PTG versus MTG | #5 |
high dose melatonin (60 mg/day) | decrease | Quality of recovery-40 score (QOR-40) | patients undergoing on-pump coronary artery bypass grafting (CABG) surgery | - | significantly decreased | #6 |
high dose melatonin (60 mg/day) | decrease | DBP | patients undergoing on-pump coronary artery bypass grafting (CABG) surgery | - | statistically significant decrease | #7 |
high dose melatonin (60 mg/day) | decrease | intubation time | patients undergoing on-pump coronary artery bypass grafting (CABG) surgery | - | statistically significant shorter | #8 |
high dose melatonin (60 mg/day) | no change | side effects | patients undergoing on-pump coronary artery bypass grafting (CABG) surgery | - | well-tolerated without any reported side effects | #9 |
high dose melatonin (60 mg/day) | decrease | myocardial I/R injury after on-pump CABG | patients undergoing on-pump coronary artery bypass grafting (CABG) surgery | - | could ameliorate | #10 |
To investigate the protective role of high dose melatonin concerning myocardial I/R injury and inflammation in patients undergoing on-pump coronary artery bypass grafting (CABG) surgery by evaluating IR/inflammatory biomarkers and clinical outcomes. This was a prospective; randomized; single-blinded placebo-controlled study conducted at cardio-thoracic surgery department of the Academy of the Cardiovascular and Thoracic Surgery, Ain Shams University. Eligible patients were randomly allocated to; melatonin-treated group (MTG) or placebo-treated group (PTG). The MTG (n = 17) received 60 mg/day melatonin capsules daily starting 5 days before surgery in addition to the standard of care. PTG (n = 17) received placebo also 5 days before surgery plus standard of care. The levels of nuclear factor kappa beta (NF-κb) (primary outcome), tumor necrosis factor (TNF-α), cardiac troponins I, and IL-6 levels were all assessed for both groups at five time points: baseline before melatonin or placebo administration (T0), before cross-clamp application(T1), 5 min after cross-clamp removal(T2), 6 h after cross-clamp removal(T3) and 24 h after cross-clamp removal(T4). Blood pressure was assessed at baseline, pre-operative and 24-hours post-operative. The Quality of recovery-40 score (QOR-40) was assessed for both groups on day 4 after surgery. TNF-α levels decreased in the MTG at T1(p = 0.034) versus PTG. At T2(p = 0.005), and T3(p = 0.04), TNF-α significantly increased in PTG versus MTG. Troponins significantly increased in PTG at T3 (p = 0.04) versus MTG. NF-κB levels declined at T1 (p = 0.013) and T2 (p = 0.0001) in MTG compared to PTG. IL-6 significantly increased in PTG versus MTG at T3 (p = 0.04). The QOR-40 score significantly decreased in MTG versus PTG. MTG had statistically significant decrease in DBP compared to the placebo group (p = 0.024). MTG had a statistically significant shorter intubation time than did the placebo group (p = 0.03). Melatonin 60 mg was well-tolerated without any reported side effects. Our findings suggested that melatonin could ameliorate myocardial I/R injury after on-pump CABG and that this outcome was essentially correlated to its antiapoptotic and anti-inflammatory effects. Trial registration: ClinicalTrials.gov registration number NCT05552586, 9/2022.