Evaluation of the sedative effect of sublingual lorazepam versus placebo in patients who are candidate for endoscopy: a double blind randomized clinical trial
Objectives: To assess the sedative effect of sublingual lorazepam versus placebo in patients who are candidate for endoscopy.
Design: a double blind randomized clinical trial.
Setting and conduct: The eligible patients who are candidate for endoscopy and will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: candidate for endoscopy; age of 18 to 55 years.
Exclusion criteria: cardiopulmonary disease; neuropsychological disorders; sensitivity to lorazepam; body mass index above 30.
Intervention group: sublingual tablet lorazepam 2 mg single dose half hour before endoscopy.
Control group: placebo single dose half hour before endoscopy
Primary outcome: sedative effect of drug half hour after treatment through physical examination.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611039014N130
Registration date:2016-11-05, 1395/08/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-11-05, 1395/08/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the sedative effect of sublingual lorazepam versus placebo in patients who are candidate for endoscopy: a double blind randomized clinical trial
Public title
Evaluation of the sedative effect of sublingual lorazepam versus placebo in patients who are candidate for endoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidate for endoscopy; age of 18 to 55 years.
Exclusion criteria: cardiopulmonary disease; neuropsychological disorders; sensitivity to lorazepam; body mass index above 30.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.UMSHA.REC.1395.347
Health conditions studied
1
Description of health condition studied
candidate for endoscopy
ICD-10 code
Y61.4
ICD-10 code description
During endoscopic examination
Primary outcomes
1
Description
sedative effect of drug
Timepoint
half hour after treatment
Method of measurement
through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: sublingual tablet lorazepam 2 mg single dose half hour before endoscopy.
Category
Treatment - Drugs
2
Description
Control group: placebo single dose half hour before endoscopy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Zohreh Seifi
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Shahid Beheshti Hospital
Full name of responsible person
Zohreh Seifi
Position
Medical Student
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
zseifi861372@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Maryam Hasan Zarini
Position
Internist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
mhzarrini@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)