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effects of melatonin as premedication agent in caesarean section

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230809059105N1
Enrollment
80
Registered
2023-08-21
Start date
2023-08-25
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy of melatonin to patient with caesarian section under spinal anesthesia with ASA I and ASA II. anxiety

Interventions

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 patien

Sponsors

Alayen universty
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Respiratory parameters, delirium, headache, nausea and vomiting, and hemodynamic parameter and Mother and child status. Timepoint: No. Method of measurement: Used monitor , Apgar score ,.

Countries

Iraq

Contacts

Public ContactHussein Jameel Abed

Alayen universty

hussein.abed@alayen.edu.iq+964 780 875 8040

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026