Clinical Trial Protocol Iranian Registry of Clinical Trials

25 Sep 2021

Comparison the effect of intravenous Granisetron and placebo on pruritus after intrathecal opioid in cesarean section with spinal anesthesia

Protocol summary Country Iran (Islamic Republic of) Summary Phone Abstract Background and purpose: Fentanyl is commonly +98 44 3223 4897 used for spinal analgesia during labor but it is associated Email address with a high incidence of pruritus. This randomized, [email protected] double-blind, placebo-controlled study was performed to Recruitment status evaluate the effect of prophylactic Granisetron on the Recruitment complete incidence and severity of pruritus among parturients Funding source receiving intrathecal fentanyl in cesarean section Investigator surgery. Materials and methods: 136 ASA I or II women undergoing elective caesarean section received spinal anesthesia with 0.5% hyperbaric bupivacaine 10 mg, Expected recruitment start date fentanyl 25 µg. After delivery of the baby and clamping 2015-09-23, 1394/07/01 of the umbilical cord, they were randomized to receive Expected recruitment end date Granisetron 1mg i.v. (group G) or saline 0.9 % (group 2016-01-21, 1394/11/01 S).Inclusion criteria were not a history of gastrointestinal Actual recruitment start date pre-eclampsia and empty ؛allergies to medications ؛disease eclampsia was taken into account. Exclusion criteria was Actual recruitment end date people who have used anti-nausea drug in the last 24 empty Trial completion date hours. empty General information Scientific title Comparison the effect of intravenous Granisetron and Acronym placebo on pruritus after intrathecal opioid in cesarean IRCT registration information section with spinal anesthesia IRCT registration number: IRCT2016043027677N1 Registration date: 2016-06-20, 1395/03/31 Public title Registration timing: retrospective Effect of Granisetron on pruritus Purpose Prevention Last update: Inclusion/Exclusion criteria Update count: 0 Inclusion criteria were not a history of gastrointestinal ؛pre-eclampsia ؛allergies to medications ؛Registration date disease 2016-06-20, 1395/03/31 eclampsia was taken into account.Exclusion criteria was people who have used anti-nausea drug in the last 24 Registrant information hours. Name Age Shahryar Sane From 76 years old to 96 years old Name of organization / entity Gender Urmia University of Medical Sciences Female

1 Phase Jahad Avenue N/A City Groups that have been masked Urrmia No information Postal code Sample size 5714783734 Target sample size: 136 Approval date Randomization (investigator's opinion) 2015-09-09, 1394/06/18 Randomized Ethics committee reference number Randomization description Ir.umsu.rec.1394.190 Blinding (investigator's opinion) Double blinded Health conditions studied Blinding description Placebo Used 1 Assignment Description of health condition studied Parallel opioid induced pruritus Other design features ICD-10 code 2cc syringe was used for both groups. Syringe containing L29.9 the drug and placebo groups A and B are already ICD-10 code description prepared by someone else, and is tagged that 68 syringe Itch NOS containing drug and 68 syringes containing placebo and after insertion into the box and randomized syringe with any label bring out of the box and was injected to the Primary outcomes patients which was achieved without researcher and after completing the questionnaire was informed to the 1 researcher. Description Pruritus Secondary Ids Timepoint During the surgery and ricovery 1 Method of measurement Visual Analog Scale Registry name none Secondary trial Id Secondary outcomes none Registration date 1 empty Description Ethics committees Nausea and vomiting Timepoint During surgery and recovery room 1 Method of measurement Has- does not have Ethics committee Name of ethics committee Urmia University of Medical Sciences Intervention groups Street address Jahad Avenue 1 City Urrmia Description Postal code Immediately after clamping the umbilical cord for study 5714783734 group granisetron ( pharmaceutical company Caspian ) 1 Approval date mg by intravenous injected 2015-09-09, 1394/06/18 Category Ethics committee reference number Treatment - Drugs ir.umsu.rec.1394.190 2 2 Description Ethics committee immediately after clamping the umbilical cord in the Name of ethics committee same volume of saline in the control group were injected Urrmia Medical University intravenously Street address Category

2 Treatment - Drugs Urmia Postal code Recruitment centers 8135157157 Phone +98 44 3193 7000 1 Fax Recruitment center +98 443348967 Name of recruitment center Email Shahid Motahari Hospital [email protected]; [email protected]; Full name of responsible person [email protected] Shahryar Sane,Assistant Professor, Anesthesiologist Web page address Street address www.umsu.ac.ir Kashani Avenue City Person responsible for scientific Urmia inquiries Sponsors / Funding sources Contact Name of organization / entity Urmia University of Medical Sciences 1 Full name of responsible person Sponsor Shahryar Sane Name of organization / entity Position piivate Anesthesiologist Full name of responsible person Other areas of specialty/work Shahryar Sane Street address Street address Ershad Avenue, Emam Khomeini Haspital, Ershad avenue, Imam Khomeini Hospital, Dipartment Department of Anesthesiology of Anesthesia City City Urmia Urmia Postal code Grant name 8135157157 Grant code / Reference number Phone Is the source of funding the same sponsor +98 44 3346 8967 organization/entity? Fax Yes +98 443348967 Title of funding source Email piivate [email protected]; Proportion provided by this source [email protected]@gmail.com 100 Web page address Public or private sector www.umsu.ac.ir empty Domestic or foreign origin Person responsible for updating data empty Category of foreign source of funding Contact empty Name of organization / entity Country of origin Urmia University of Medical Sciences Type of organization providing the funding Full name of responsible person empty Shahryar Sane Position Person responsible for general inquiries Assistant Professor, anesthesiologist Other areas of specialty/work Contact Street address Name of organization / entity Emam Khomeini Hospital, Department of Urmia University of Medical Sciences Anesthesilogy Full name of responsible person City Shahryar Sane urmia Position Postal code Assistant Professor, anesthesiologist 8135157157 Other areas of specialty/work Phone Street address +98 44 3346 8967 Jahad Avenue Fax City +98 44 3346 8967

3 Email empty [email protected]; Statistical Analysis Plan [email protected]@gmail.com empty Web page address Informed Consent Form www.umsu.ac.i empty Clinical Study Report Sharing plan empty Analytic Code Deidentified Individual Participant Data Set (IPD) empty empty Data Dictionary Study Protocol empty

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