effects of melatonin as premedication agent in caesarean sectio
- Conditions
- Efficacy of melatonin to patient with caesarian section under spinal anesthesia with ASA I and ASA II.anxietyF06.4
- Registration Number
- IRCT20230809059105N1
- Lead Sponsor
- Alayen universty
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 80
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Respiratory parameters, delirium, headache, nausea and vomiting, and hemodynamic parameter and Mother and child status. Timepoint: No. Method of measurement: Used monitor , Apgar score ,.