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IRCT20190120042432N1 IRCT 2019-07-21 Arak University of Medical Sciences Comparison of two oral precursors of melatonin and gabapentin in female candidates for cesarean section under spinal anesthesia Comparison of two oral precursors of melatonin and gabapentin in female candidates for cesarean section under spinal anesthesia 2019-07-23 anticipated 93 Complete https://irct.ir/trial/37882 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: یفتفلPatients were randomized according to the charts which was derived from www.randomization.com site, Blinding description: pregnant woman undergoing cesarean section and investigators were blinded to the study treatments. 2-3 Evaluation of pain and anxiety in female candidates for cesarean section under spinal anesthesia. Intervention 1: 31persons receive 300 mg oral gabapentin, 30 minutes before the onset of spinal anesthesia. Intervention 2: 31persons receive 3 mg oral melatonin, 30 minutes before the onset of spinal anesthesia. Yes - There is a plan to make this available What will be shared: All agreed items for publication, such as shared data, study protocol, statistical analysis map, informed consent form, clinical study report, codes used in the database, and data classification system after unidentifiable individuals and maintaining of privacy are publishable. When: The beginning of the access period one year after the publication of the results To whom: Only scholars working in academia Conditions: In order to use in other studies and scientifics work and obtain information for the preparation of the article Where to obtain: Daudabadi Farahani Samira To email address setaresetare004@gmail.com How to obtain: No need for a specific process and sent by email. Comments:
public Yazdi Bijan
Arak University of medical sciences,Pardis Site,Sardasht
Arak Iran (Islamic Republic of) 3951616558 +98 86 3417 3506 yazdi.b@arakmu.ac.ir Arak University of Medical Sciences scientific Yazdi Bijan
Arak University of medical sciences,Pardis Site,Sardasht
Arak Iran (Islamic Republic of) 3951616558 +98 86 3417 3506 yazdi.b@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) full-term pregnant women aged 18 to 40 years old undergoing elective cesarean section under spinal anesthesia 18 years 40 years Female contraindications for gabapentin or melatonin failed or partial spinal anesthesia gravidity more than 3 Intrauterine Growth Restriction fetal distress history of alcoholism, drug abuse ,convulsion, migraine, dicopathy ,hepatitis ,renal failure ,cardiovascular or pulmonary diseases ,preeclampsia or eclampsia, hypertension, diabete Treatment - Drugs Treatment - Drugs 31persons receive 300 mg oral gabapentin, 30 minutes before the onset of spinal anesthesia. 31persons receive 3 mg oral melatonin, 30 minutes before the onset of spinal anesthesia. The rate of anxiety and postoperative pain. Timepoint: Based on the Verbal Anxiety Scale, anxiety and pain levels is measure before premedication, before spinal anesthesia, five minutes after spinal anesthesia, after exiting the infant, and 15 minutes after spinal anesthesia as well as after surgery and patient transmission to recovery. Method of measurement: With using the Verbal Anxiety Scale. The amount of the analgesic drug. Timepoint: Within 12 hours after surgery. Method of measurement: 5 cc syringe using for drug injection. Arak University of Medical Sciences Approved 2018-01-24 Ethics Committee of Arak University of Medical Sciences Arak University of medical sciences, Pardis site,Sardasht Arak Markazi Iran (Islamic Republic of)