A double-blind randomized placebo - controlled trial of melatonin as premedication agent in Caesarean section

To investigate the impact of melatonin as a premedication agent in Caesarean section on blood loss and pain level postoperative.

We randomly allocated them every group has 40 patients, melatonin group (M) and placebo group (P). The dose was given to patient at the night and 90 minutes before the operation (10 mg) sublingually per doses

A double-blind randomized placebo - controlled trial

: age exceeding 18 years, categorized as ASA I or ASA II (pertaining to the American Society of Anesthesiologists Physical Status Classification System, signifying a patient in good health or with mild systemic illness, respectively), pregnancy at a gestational age surpassing 37 weeks exclusions criteria which indicates severe systemic disease or a constant threat to life, documented drug allergy to melatonin or any other study medications, contraindications for spinal anesthesia such as spinal abnormalities or infections, inability of the patient to respond or demonstrate awareness to the questions rose

Prior to subarachnoid block administration, all subjects were administered a lactated Ringer's solution intravenous preload , a Quincke needle with a gauge of 25 are used while the patient was in a seated position. oxytocin was administered intravenously Haemoglobin levels were assessed prior to and 12 hours subsequent to the surgical procedure. In addition to the pre- and post-surgery haemoglobin level changes, blood loss was assessed using two methods: a) the weight difference of materials used before and after surgery, and b) the volume of blood collected in the suction bottle following placental delivery, both measured in milliliters (ml).

anxiety sedation blood loss postoperative opioid conception postoperative pain intensity

An epidemiologist, who was not considered a participant in the clinical trial, will set up a random sequence for the purpose of arranging the administration of the substance used in the study, randomization will occur on a 1:1 ratio of melatonin to placebo, and deliver it to a second person who does not know the exact substance content, as they do not Participating in the clinical study as well, also not recruited by the epidemiologist who prepared the random sequencing. Both melatonin and placebo tablets are indistinguishable and will be contained in bags individually prepared by an epidemiologist. The researcher and all participants will not be able to distinguish the type of drug that was administered to the patient. At the time of assigning study participants, the symbol appearing on the treatment bag that was administered to the patient will be identified on the assessment form. Then, all data and tissue samples collected from the participant will be classified and stored only using this code associated with the randomly distributed treatment.

An epidemiologist, who was not considered a participant in the clinical trial, will set up a random sequence for the purpose of arranging the administration of the substance used in the study, randomization will occur on a 1:1 ratio of melatonin to placebo, and deliver it to a second person who does not know the exact substance content, as they do not Participating in the clinical study as well, also not recruited by the epidemiologist who prepared the random sequencing. Both melatonin and placebo tablets are indistinguishable and will be contained in bags individually prepared by an epidemiologist. The researcher and all participants will not be able to distinguish the type of drug that was administered to the patient. At the time of assigning study participants, the symbol appearing on the treatment bag that was administered to the patient will be identified on the assessment form. Then, all data and tissue samples collected from the participant will be classified and stored only using this code associated with the randomly distributed treatment.

primary data include anxiety, sedation, blood loss, postoperative opioid conception, and postoperative pain intensity. Secondary data will be gathered using respiratory parameters, delirium, headache, nausea and vomiting, and hemodynamic parameter. Finally, personal observations and photographs were taken at the study area to supplement the data analysis with valid inputs.

we started to collect the data from 1/3/2023 to 30/6/2023

. The selected samples are patients in Bint-Alhuda hospital in Al Nasiriyah included adult women patients of both sexes (18 to 45 years of age) undergoing c/s procedure for which it was necessary to use spinal anaesthesia.

: age exceeding 18 years, categorized as ASA I or ASA II, pregnancy at a gestational age surpassing 37 weeks, unbroken membranes, scheduled surgical procedures, patient agreement and contentment with study participation, and women with a solitary pregnancy.

Bint-Alhuda hospital at the Al-Nasiriyah city of Iraq. Al-Nasiriyah city is in the Governorate of Thiqar, south of Iraq. The city is situated between longitude 31º 08′ E and 31º 01′ E and latitude 46º 18′ N 46º and 08′ N.

After obtaining institutional ethic committee approval with code 37/2021 and patients’ informed consent, this prospective randomized double-blind study was conducted in the operating theatre of caesarean sections

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