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IRCT20110712007013N26 IRCT 2020-01-17 Tabriz University of Medical Sciences The effect of Sprotte or Quincke spinal needles on the frequency and severity of transient neurologic syndrome Comparison of Sprotte and Quincke Spinal Needles on the Frequency and Severity of Transient Neurologic Syndrome (TNS) after Spinal Anesthesia in Patients undergoing Cesarean Delivery 2019-12-22 anticipated 160 Complete https://irct.ir/trial/44435 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients wishing to participate in the study who meet the inclusion criteria will be selected as convenient sampling and then randomly assigned to two control and intervention groups using Randlist software, Blinding description: In present study, patients, investigator, care provider, outcome assessor and data analyzer are blinded to participants study groups. The study team includes an anesthesiologists, who is responsible for data collection and outcome assessing, who is not in charge of anesthesia management, thus is not aware of interventions and study group. In addition, all study groups and subsequent interventions will be introduced to the patients and it will been mentioned in the written consent that patients will be blinded to the study groups and interventions .Patients are allocated into study and control groups, according to a two blocked randomization list that is prepared using online software at a 1:1 ratio. The list is coded (A or B) that is preprinted in sealed-envelope packets. Except for one of anesthetists, all of researchers are blinded to the type of spinal needle for every patient during the study. N/A The effect of Sprotte and Quincke spinal needles on the frequency and severity of neurological syndrome. Intervention 1: Intervention group: The patients of this group (n=80) using of Sprotte( manufacturer: B brown) spinal needle G25 undergoing spinal anesthesia. Intervention 2: Control group: The patients of this group (n=80) using of Quincke ( manufacturer: B brown)spinal needle G25 undergoing spinal anesthesia. 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 further information
public Dr. Simin Atashkhoyi
Al-Zahra Hospital, South Artesh Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3553 9161 satashkhoyi@gmail.com Tabriz University of Medical Sciences scientific Dr. Simin Atashkhoyi
Al-Zahra Hospital, South Artesh Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3553 9161 satashkhoyi@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Candidate for elective cesarean delivery Candidate for spinal anesthesia Patients between 18-40 years ASA Class I&II Term and singleton pregnancy 18 years 40 years Female Weight over 100 kg and height less than 150 cm Allergy to local anesthetics medicines History of psychiatric disease Spinal cord stenosis and lumbar discopathy History of systemic diseases (cardiovascular, hepatic, pulmonary, ...) O74.6 Other complications of spinal and epidural anesthesia during labor and delivery Treatment - Devices Treatment - Devices Intervention group: The patients of this group (n=80) using of Sprotte( manufacturer: B brown) spinal needle G25 undergoing spinal anesthesia. Control group: The patients of this group (n=80) using of Quincke ( manufacturer: B brown)spinal needle G25 undergoing spinal anesthesia Time of onset of symptoms of transient neurological syndrome. Timepoint: 6 to 48 hours after surgery. Method of measurement: Physical examination. Duration of symptoms of transient neurological syndrome after recovery from anesthesia. Timepoint: 6 to 48 hours after surgery. Method of measurement: Physical examination. Severity of pain caused by transient neurological syndrome. Timepoint: 6 to 48 hours after surgery. Method of measurement: Similar verbal scoring. Type of treatment used for transient neurological syndrome. Timepoint: 6 to 48 hours after surgery. Method of measurement: Clinical record. The dose of treatment used to treat transient neurological syndrome. Timepoint: 6 to 48 hours after surgery. Method of measurement: Clinical record. Tabriz University of Medical Sciences Approved 2019-12-09 Ethics Committee of Tabriz University of Medical Sciences Vice chancellor for research, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)