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IRCT20230809059105N1 IRCT 2023-08-21 Alayen universty effects of melatonin as premedication agent in caesarean section EMSC A double-blind randomized placebo - controlled trial of melatonin as premedication agent in Caesarean section 2023-08-25 anticipated 80 Complete https://irct.ir/trial/71972 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 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, Blinding description: 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. N/A Efficacy of melatonin to patient with caesarian section under spinal anesthesia with ASA I and ASA II. Intervention 1: Intervention group: Eighty patients who had been scheduled for cesarean section under spinal anesthesia were enrolled in the study. 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. Intervention 2: Control group: Eighty patients who had been scheduled for cesarean section under spinal anesthesia were enrolled in the study. 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. Yes - There is a plan to make this available What will be shared: 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. When: we started to collect the data from 1/3/2023 to 30/6/2023 To whom: . 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. Conditions: : 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. Where to obtain: 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. How to obtain: 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 Comments: Thank you for giving me the opportunity to register on the site. I hope to receive your valuable comments as soon as possible so that they can be taken into account in order to evaluate the work. I have the utmost respect for you.
public Hussein Jameel Abed
Alhaboby street
Thi-qar Iraq 00964 +964 780 875 8040 hussein.abed@alayen.edu.iq Alayen universty scientific Mohamed Kahloul
Sahlool - streets
Sousse Tunisia 00216 +216 23 567 317 med.kahloul@outlook.fr university of Sousse Iraq The study's inclusion criteria encompassed individuals who fulfilled the subsequent requirements: 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, unbroken membranes, scheduled surgical procedures, patient agreement and contentment with study participation, and women with a solitary pregnancy. 18 years no limit Female The exclusion criteria for the study encompass several factors, including ASA III or higher, 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, a history of mental or neurological diseases that could affect the patient's ability to participate or comprehend the study procedures, addiction to substances that could interfere with the study outcomes, disapproval or dissatisfaction expressed by the patient regarding their involvement in the study, presence of congenital malformations in the fetus detected during routine prenatal screening, inability to provide informed consent due to intellectual impairment or other factors, significant heart disease that could pose additional risks during the surgical procedure. F06.4 anxiety Treatment - Drugs Placebo Intervention group: Eighty patients who had been scheduled for cesarean section under spinal anesthesia were enrolled in the study. 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 Control group: Eighty patients who had been scheduled for cesarean section under spinal anesthesia were enrolled in the study. 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 Blood losses and pain level. Timepoint: no. Method of measurement: . The hemoglobin levels before and 12 h after surgery, the mean weight of the materials used in the operation time, and amount of blood suction. Visual pain score and analgesic administration were using to measure level of pain. Respiratory parameters, delirium, headache, nausea and vomiting, and hemodynamic parameter and Mother and child status. Timepoint: No. Method of measurement: Used monitor , Apgar score ,. Secondary data will be gathered using respiratory parameters, delirium, headache, nausea and vomiting, and hemodynamic parameter. Impact of melatonin as a premedication agent in Caesarean section on blood loss and pain level postoperative www.alayen.edu.iq Approved 2021-09-21 Iraq ministry of health Alhaboby street Thi-qar Nassyreia Iraq