Clinical Trial Protocol Iranian Registry of Clinical Trials

01 Oct 2021

Comparison of Gabapentin, Pregabalin and placebo as premedication for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation

Protocol summary University of Medical Sciences Country Summary (Islamic Republic of) Introduction: Tracheal intubation and direct laryngoscopy Phone are powerful noxious stimuli that can elicited +98 44 3346 8967 hemodynamic responses and should be attenuated by Email address appropriate premedication, smooth induction and rapid [email protected] intubation. The aim of this study is to compare the effect of gabapentin and pregabalin as premedication for Recruitment status attenuation of hemodynamic response to laryngoscopy Recruitment complete and endotracheal intubation. Methods: In a prospective Funding source double blinded randomized clinical trial, a total of 90 Urmia University of Medical Sciences normotensive adult consented patients aged 20–50 years, ASA grade I and II, of both gender will be Expected recruitment start date randomized into three groups. Group I will received oral 2017-05-22, 1396/03/01 placebo, Group II oral gabapentin 900 mg and Group III Expected recruitment end date oral pregabalin 150 mg 2 h prior to induction of 2017-08-23, 1396/06/01 anesthesia. Anesthetic technique will be same and all Actual recruitment start date groups will be assessed for, hemodynamic changes after empty the premedication, before and after induction, and Actual recruitment end date 1,3and 5 min after laryngoscopy and intubation. empty Trial completion date General information empty

Acronym Scientific title IRCT registration information Comparison of Gabapentin, Pregabalin and placebo as IRCT registration number: IRCT2017041133365N1 premedication for attenuation of hemodynamic response Registration date: 2017-06-24, 1396/04/03 to laryngoscopy and endotracheal intubation Registration timing: registered_while_recruiting Public title Comparison of Gabapentin, Pregabalin and placebo as Last update: premedication for attenuation of hemodynamic response Update count: 0 to laryngoscopy and endotracheal intubation Registration date Purpose 2017-06-24, 1396/04/03 Prevention Inclusion/Exclusion criteria Registrant information Inclusion criteria: 20-50 yrs old; physical status I, II; Name elective under general anesthesia; tracheal Alireza Mahoori intubation with cuffed tube. Exclusion criteria: Morbid Name of organization / entity obesity; history of allergy; history of study drugs

1 consumption. Method of measurement Age Monitoring From 20 years old to 50 years old Gender 2 Both Description Phase systolic BP N/A Timepoint Groups that have been masked 1,3, and 5 min after intubation No information Method of measurement Sample size Monitoring Target sample size: 90 Randomization (investigator's opinion) Randomized 3 Randomization description Description Blinding (investigator's opinion) Diastolic Double blinded Timepoint Blinding description 1,3, and 5 min after intubation Placebo Method of measurement Used Monitoring Assignment Parallel Other design features Secondary outcomes empty Secondary Ids empty Intervention groups

Ethics committees 1 Description 1 Group III will receive oral pregabalin 150 mg (Sobhan) 2 Ethics committee h prior surgery Name of ethics committee Category Ethic commity of Urmia University of Medical Sciences Treatment - Drugs Street address Jahad st. 2 City Urmia Description Postal code Control group will receive oral placebo 2 h before surgery Approval date Category 2013-09-23, 1392/07/01 Treatment - Drugs Ethics committee reference number UMSU.REC.1392.239 3 Health conditions studied Description Group II will receive oral gabapentin 900 mg (Razak), 2h before surgery 1 Category Description of health condition studied Treatment - Drugs Laryngoscopy and intubation in elective surgery ICD-10 code Recruitment centers ICD-10 code description 1 Primary outcomes Recruitment center Name of recruitment center 1 Imam Khomeini Hospital Description Full name of responsible person HR Street address Timepoint City 1,3, and 5 min after intubation Urmia

2 Sponsors / Funding sources Person responsible for scientific inquiries 1 Contact Sponsor Name of organization / entity Name of organization / entity Urmia University of Medical Sciences Vice Chancellor for research of ,Urmia University of Full name of responsible person Medical Sciences Alireza Mahoori Full name of responsible person Position Dr. Iraj Mohebbi Professor Street address Other areas of specialty/work Jahad st. Urmia University Street address City Ershad street, Imam Khomeini Hospital Urmia City Grant name Urmia Grant code / Reference number Postal code Is the source of funding the same sponsor Phone organization/entity? +98 443468967 Yes Fax Title of funding source Email Vice Chancellor for research of ,Urmia University of [email protected] Medical Sciences Web page address Proportion provided by this source 100 Person responsible for updating data Public or private sector empty Contact Domestic or foreign origin Name of organization / entity empty Full name of responsible person Category of foreign source of funding Alireza Mahoori empty Position Other areas of specialty/work Country of origin Street address Type of organization providing the funding City empty Postal code Phone Person responsible for general inquiries 00 Fax Contact Email Name of organization / entity Web page address Urmia University of Medical Sciences Full name of responsible person Alireza Mahoori Sharing plan Position Deidentified Individual Participant Data Set (IPD) Professor empty Other areas of specialty/work Study Protocol Street address empty Urmia, Ershad street, Imam Khomeini Hospital Statistical Analysis Plan City empty Urmia Informed Consent Form Postal code empty Phone Clinical Study Report +98 44 3346 8967 empty Fax Analytic Code Email empty [email protected] Data Dictionary Web page address empty

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