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IRCT20211218053439N1 IRCT 2022-02-22 Islamic Azad University Effect of cyproheptadine on headache and hypotension after spinal anesthesia Preventive effect of cyproheptadine in preventing headache and hypotension in spinal anesthesia in patients undergoing spinal anesthesia 2022-02-20 anticipated 56 Complete https://irct.ir/trial/60788 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Our aim is to categorize the subjects in two separate groups; A(cyproheptadine) and B(control). To achieve this goal, 4 blocks Will be randomly chosen; AABB, BABA, BAAB, BBAA, which will each be put in a packet afterwards, so that selection of each packet is equally random. For the first 4 participants a block will randomly chosen and selection of the remaining will follow the rule, Blinding description: The participants, who are fully informed about the study, will not be cognisant of whether they are receiving cyproheptadine or placebo, whereas the research crew including the physician, the nurse, the person responsible for collecting data, the researcher, and the person preparing the draft article and the Safety and Data Monitoring Committee will be aware of the type of medication applied. It is worth mentioning that we will use placebo for blinding in this study. The placebo will be prepared exactly the same as the main drug(cyproheptadine) in terms of both colour and shape, with the cooperation of one of the pharmacy universities. Afterwards, they will be given to the participants. 2 Spinal anesthesia induced headache and hypotension. Intervention 1: Intervention group: Receiving cyproheptadine tablets with a dose of 4 mg and single dose orally. Intervention 2: Control group: receiving single-dose ciproheptadine placebo tablets orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Zahra Farhadi
Islamic Azad University of Shahroud, University Blvd
Shahrood Iran (Islamic Republic of) 36199-43189 +98 23 3220 1378 sabafarhadi9675@gmail.com Islamic Azad University scientific Yosef Kolokhi
Islamic Azad University of Shahroud, University Blvd
Shahrood Iran (Islamic Republic of) 36199-43189 +98 23 3222 7087 dryousefkolookhianestezi@gmail.com Islamic Azad University Iran (Islamic Republic of) Surgery under spinal anesthesia Elective surgery American Society of Anesthesiologists(ASA) class I Age between 20 and 70 years 20 years 70 years Both Reluctance to participate in the study Having any underlying disease Emergency surgery - - Treatment - Drugs Placebo Intervention group: Receiving cyproheptadine tablets with a dose of 4 mg and single dose orally Control group: receiving single-dose ciproheptadine placebo tablets orally Spinal anesthesia-induced headache. Timepoint: Evaluation of headache at the beginning of the study (before surgery) and 24 and 48 hours after surgery. Method of measurement: Through questionnaire. Spinal anesthesia-induced hypotension. Timepoint: Measurement of blood pressure at the beginning of the study (before surgery) and 24 and 48 hours after surgery. Method of measurement: Blood pressure monitoring. Islamic Azad University Approved 2021-02-06 Research Ethics Committees of Islamic Azad University - Shahrood Branch Islamic Azad University of Shahroud, University Blvd., Shahroud Shahrood Semnan Iran (Islamic Republic of)