Introduction: Tracheal intubation and direct laryngoscopy are powerful noxious stimuli that can elicited hemodynamic responses and should be attenuated by appropriate premedication, smooth induction and rapid intubation. The aim of this study is to compare the effect of gabapentin and pregabalin as premedication for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation.
Methods: In a prospective double blinded randomized clinical trial, a total of 90 normotensive adult consented patients aged 20–50 years, ASA grade I and II, of both gender will be randomized into three groups. Group I will received oral placebo, Group II oral gabapentin 900 mg and Group III oral pregabalin 150 mg 2 h prior to induction of anesthesia. Anesthetic technique will be same and all groups will be assessed for, hemodynamic changes after the premedication, before and after induction, and 1,3and 5 min after laryngoscopy and intubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041133365N1
Registration date:2017-06-24, 1396/04/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-24, 1396/04/03
Registrant information
Name
Alireza Mahoori
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 8967
Email address
mahouri.a@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Gabapentin, Pregabalin and placebo as premedication for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation
Public title
Comparison of Gabapentin, Pregabalin and placebo as premedication for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 20-50 yrs old; physical status I, II; elective surgery under general anesthesia; tracheal intubation with cuffed tube.
Exclusion criteria: Morbid obesity; history of allergy; history of study drugs consumption.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic commity of Urmia University of Medical Sciences
Street address
Jahad st.
City
Urmia
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
UMSU.REC.1392.239
Health conditions studied
1
Description of health condition studied
Laryngoscopy and intubation in elective surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
HR
Timepoint
1,3, and 5 min after intubation
Method of measurement
Monitoring
2
Description
systolic BP
Timepoint
1,3, and 5 min after intubation
Method of measurement
Monitoring
3
Description
Diastolic
Timepoint
1,3, and 5 min after intubation
Method of measurement
Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Group III will receive oral pregabalin 150 mg (Sobhan) 2 h prior surgery
Category
Treatment - Drugs
2
Description
Control group will receive oral placebo 2 h before surgery
Category
Treatment - Drugs
3
Description
Group II will receive oral gabapentin 900 mg (Razak), 2h before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Street address
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of ,Urmia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Jahad st. Urmia University
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of ,Urmia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Alireza Mahoori
Position
Professor
Other areas of specialty/work
Street address
Urmia, Ershad street, Imam Khomeini Hospital
City
Urmia
Postal code
Phone
+98 44 3346 8967
Fax
Email
at_mahoori@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Alireza Mahoori
Position
Professor
Other areas of specialty/work
Street address
Ershad street, Imam Khomeini Hospital
City
Urmia
Postal code
Phone
+98 443468967
Fax
Email
at_mahoori@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Alireza Mahoori
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)