The aim of this study is to determine the effect of clonazepam to reduce anxiety before surgery in patients referred to the Department of Surgery, Shiraz Dental School. Among under 18 years old patients referred to this center, 30 patients will receive placebo and 30 patients will receive drug, that is a single dose of clonazepam 2 M.G an hour before surgery. Anxiety is shown by these indices: Visual Analogue Scale, blood pressure, pulse rate and oxygen saturation of blood.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012195420N1
Registration date:2011-06-18, 1390/03/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-18, 1390/03/28
Registrant information
Name
Navid Arasteh
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1230 1192
Email address
arastehn@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences and Health Services
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of preoperative clonazepam to reduce anxiety of patients referred to the Department of Surgery, Shiraz Dental School
Public title
The effect of clonazepam to reduce anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: patients referred to the Department of Surgery, Shiraz Dental School.
Exclusion Criteria: children and people under 18; addicts; smoking; all systemic diseases; women during menstruation; and all drugs consumers.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences and Health Services
Street address
Zand st.
City
Shiraz
Postal code
Approval date
2011-05-22, 1390/03/01
Ethics committee reference number
CT-90-5558
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Anxiety
Timepoint
1 hour
Method of measurement
Visual Analogue Scale
2
Description
Blood pressure
Timepoint
1 hour
Method of measurement
mm HG by using a Digital Manometer
3
Description
Pulse rate
Timepoint
1 hour
Method of measurement
number per minutes by Digital Pulse Oximetry
4
Description
Oxygen saturation of blood
Timepoint
1 hour
Method of measurement
percent by Digital Pulse Oximetry
Secondary outcomes
empty
Intervention groups
1
Description
One dose of clonazepam 2 m.g one hour before surgery
Category
Treatment - Drugs
2
Description
Placebo one hour before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Navid Arasteh
Street address
Ghasro dasht st.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Gholam Reza Hatam
Street address
Zand st.
City
Shiraz
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 Shiraz University of Medical Sciences and Health Services
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
Shiraz Dental School
Full name of responsible person
Navid Arasteh
Position
student
Other areas of specialty/work
Street address
Ghasro dasht st.
City
Shiraz
Postal code
Phone
+98 71 1626 2193
Fax
Email
arastehn@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Dr. Barbod Zamiri
Position
Oromaxilo Facial Surgeon
Other areas of specialty/work
Street address
Ghasro dasht st.
City
Shiraz
Postal code
Phone
+98 71 1626 2193
Fax
Email
zamirib@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Navid Arasteh
Position
student
Other areas of specialty/work
Street address
Ghasro dasht st.
City
Shiraz
Postal code
Phone
+98 71 1230 1192
Fax
Email
arastehn@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)