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IRCT20200107046042N1 IRCT 2020-09-01 Ahvaz University of Medical Sciences The effect of dexmedetomidine on shivering after cesarean section The effect of intravenous dexmedetomidine on shivering after elective cesarean section under intrathecal anesthesia 2020-07-22 anticipated 80 Complete https://irct.ir/trial/44965 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly assigned into two groups of experimental and control. Assignment of patients to the study groups will be done by block randomization method using blocks of size four, Blinding description: Intervention (receiving dexmedetomidine or normal saline) and patient evaluation will be carried out by a physician who is blinded to both treatment groups. Also patients and statistical analyzer will not know about patient grouping. 3 Shivering after cesarean section. Intervention 1: Intervention group: Dexmedetomidine 0.5 µg/kg (Exir CO., Iran) diluted with normal saline in a volume of 20 cc will be injected at a rate of 120 cc/h during 10 minutes, after cord clamping. Intervention 2: Control group: Normal saline 20 cc will be injected at a rate of 120 cc/h during 10 minutes after the cord clamping. 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 Sholeh Nesioonpour
Imam Khomeini Hospital, Azadegan street
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3222 2818 drnesioon@gmail.com Ahvaz University of Medical Sciences scientific Sholeh Nesioonpour
Imam Khomeini Hospital, Azadegan street
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3222 2818 drnesioon@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 35 years ASA Class I and II Gravida I and II pregnant women Candidate for elective cesarean section Consent to participate in the study 18 years 35 years Female History of seizure Severe renal or liver disease Maternal febrile disorder Coagulation disorder R68.83 Chills (without fever) Prevention Prevention Intervention group: Dexmedetomidine 0.5 µg/kg (Exir CO., Iran) diluted with normal saline in a volume of 20 cc will be injected at a rate of 120 cc/h during 10 minutes, after cord clamping. Control group: Normal saline 20 cc will be injected at a rate of 120 cc/h during 10 minutes after the cord clamping. ُShivering. Timepoint: Every 5 minutes until 45 minutes after block. Method of measurement: Chu and Tsai score. Body temperature. Timepoint: Before intrathecal anesthesia and every 5 minutes after drug administration for 45 minutes. Method of measurement: Tympanic Thermometer (Micro Life, Madisa Novin Peish Co, Taiwan). Systolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and then every 5 minutes. Method of measurement: Mercury barometer. Diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and then every 5 minutes. Method of measurement: Mercury barometer. Nausea after surgery. Timepoint: Up to 2 hours after the patient entry to recovery. Method of measurement: Presence of nausea based on direct observation and patients report. Vomiting after surgery. Timepoint: Up to 2 hours after the patient entry to recovery. Method of measurement: Presence of vomiting based on direct observation and patients report. Ahvaz University of Medical Sciences Approved 2020-06-29 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)