]>
IRCT20190327043122N1 IRCT 2020-03-03 Mashhad University of Medical Sciences Effect of Ondansetron on block of spinal anesthesia Effect of preoperative intravenous Ondansetron on level and time to regression of sensory and motor block in patients undergoing cesarean section during spinal anesthesia 2019-11-22 anticipated 160 Complete https://irct.ir/trial/41160 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients is divided into two equal groups according to the table of random numbers (simple randomization) . In closed envelopes, syringes containing 2 cc of solution are provided by the anesthesiologist. Group A received ondansetron and group B received normal saline , Blinding description: Since the drug form is the same in both groups and the injection method is the same, it is not possible for patients to identify the drug group in the operating room during surgery. The assessor and analyst will also be blinded of the groups. But the researcher that present during surgery will not be blind to the groups. 3 Effect of ondansetron on level and time to regression of sensory and motor block in spinal anesthesia. Intervention 1: Intervention group: 4 miligrames(2cc) ondansetron (IV),15 minutes before spinal anesthesia with 2.5 cc hyperbaric bupivacaine is administered. In the event of a hypotension and bradicardia, more than 20% of the basal, 5-10 milligrames ephedrine and 0.5 to 1 mg atropine is injected , respectively. Intervention 2: Control group: 2cc normal saline (IV),15 minutes before spinal anesthesia with 2.5 cc hyperbaric bupivacaine is administered. In the event of a hypotension and bradicardia, more than 20% of the basal, 5-10 milligrames ephedrine and 0.5 to 1 mg atropine is injected , respectively. Yes - There is a plan to make this available What will be shared: Inforamations related to the primary outcomes When: Starting 6 months after publication To whom: ّFor people working in academic institutions and businesses Conditions: people working in academic institutions Where to obtain: Asgharisa@mums.ac.ir How to obtain: During 3-5 days Comments:
public Saleheh Asghari
Shareeati Square, Qaem hospital
mashhad Iran (Islamic Republic of) 9478791878 +98 51 3840 0000 asgharisa@mums.ac.ir Mashhad University of Medical Sciences scientific Saleheh Asghari
Shaaeeari Square, Qaem Hospital
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3840000 asgharisa@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) women who candidate for cesarean section without any hearing problems , without neurologic disorders or use of alfa 2 agonists or calcium channel blockers in the last month Have not contraindication criteria for spinal anesthesia Have not history of long QT in the patient and family. 18 years 45 years Female need to general anesthesia O74 Complications of anesthesia during labor and delivery Treatment - Drugs Placebo Intervention group: 4 miligrames(2cc) ondansetron (IV),15 minutes before spinal anesthesia with 2.5 cc hyperbaric bupivacaine is administered. In the event of a hypotension and bradicardia, more than 20% of the basal, 5-10 milligrames ephedrine and 0.5 to 1 mg atropine is injected , respectively. Control group: 2cc normal saline (IV),15 minutes before spinal anesthesia with 2.5 cc hyperbaric bupivacaine is administered. In the event of a hypotension and bradicardia, more than 20% of the basal, 5-10 milligrames ephedrine and 0.5 to 1 mg atropine is injected , respectively. Level and time to regression of sensory block in spinal anesthesia. Timepoint: Every 2 minutes after spinal anesthesia until fixation of sensory level then every 30 minutes till regression of block to the level of S1. Method of measurement: blunt niddle. Time to reverse of motor block in spinal anesthesia. Timepoint: Every 30 minutes till regression of motor block. Method of measurement: Table of Modified Bromage scale. Systolic blood pressure(SBP). Timepoint: Before and immediately after spinal anesthesia and every 3 minutes untill 30 minutes then every 5 minutes untill the end of surgery. Method of measurement: Sphygmomanometer. Diastolic blood pressure(DBP). Timepoint: Before and immediately after spinal anesthesia and every 3 minutes untill 30 minutes then every 5 minutes untill the end of surgery. Method of measurement: Sphygmomanometer. Mean arterial pressure(MAP). Timepoint: Before and immediately after spinal anesthesia and every 3 minutes untill 30 minutes then every 5 minutes untill the end of surgery. Method of measurement: Sphygmomanometer. Heart rate(HR). Timepoint: Before and immediately after spinal anesthesia and every 3 minutes untill 30 minutes then every 5 minutes untill the end of surgery. Method of measurement: Cardiac monitoring(5 leads). Pulse oximetry (SpO2). Timepoint: Before and immediately after spinal anesthesia and every 3 minutes untill 30 minutes then every 5 minutes untill the end of surgery. Method of measurement: pulse oximetry. Mashhad University of Medical Sciences Approved 2019-10-12 Ethic committee of Mashhad University of Medical Sciences Shareeati Square , Qaem Hospital mashhad Razavi Khorasan Iran (Islamic Republic of)