In this study, we compared the effort of oral propranolol and lorzepam, and combination of these two medications in diminishing anxiety before operation and diminishing of BP and HR before and during operation. In this double blind study, at the night before operation, 75 patients in range of 18-45 years old with ASA class I and II were arranged in 3 groups: A, B and C. These paints were had prepared for minor or moderate elective surgery. After assessment of patients’ anxiety with APIAS scale and after measurement of BP and HR of them, the drugs were prescribed. Group A took 2 mg lorazepam, group B took 20 mg propranolol, and C took 2mg lorazepam and 20 mg propranolol at 10:000 pm before next morning operation. The patients at entrance of operating room were assessed with APIAS and were checked for BP and HR again. All of patients had general anesthesia by similar rout. From the time of intubation till 15 minutes after that, BP and HR were checked every 5 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106146256N2
Registration date:2011-06-19, 1390/03/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-19, 1390/03/29
Registrant information
Name
Sevak Hatamian
Name of organization / entity
Qazvin university of medical sciences and health servics
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6381
Email address
sehatamian@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research,Qazvin universitiy of medical sciences and health services
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between effect of oral propranolol, lorazpam and propranolol-lorazpam in reduction of preoperative anexiety
Public title
The comparison between effect of orally propranolol lorazpam and propranolol-lorazpam in reduction of preoperative anexiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Grasp testimonial; elective minor to moderate surgery as: inguinal hernia, trans urethral lithothomy , colles fx, tibia fx; age 18-45 and ASA class Iand II
Exclusion criteria:
History of chronic consumption of bzd antipsychotics, opium and amphetamines; history of panic attack or any psychologic disorder; history of CHF, asthma COPD ,dm type Iand II; history of hypertension; history of any anti hypertension drug consumption and history of any food and drugs allergy
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin universityof medical sciences
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2009-08-10, 1388/05/19
Ethics committee reference number
4372/20/28
Health conditions studied
1
Description of health condition studied
Neurotic, stress-related and somatoform disorders
ICD-10 code
F40.9
ICD-10 code description
Phobic anxiety disorder, unspecified
Primary outcomes
1
Description
Preoprative stress score
Timepoint
10 hours
Method of measurement
APIAS SCALE
Secondary outcomes
1
Description
Blood pressure
Timepoint
15 mint
Method of measurement
Non-Invasive Blood Pressure (NIBP)
2
Description
Heart rate
Timepoint
15min
Method of measurement
beat/min
Intervention groups
1
Description
Intervention:inderal 20mg
Category
Prevention
2
Description
Intervention:lorazpam2mg
Category
Prevention
3
Description
Intervention:inderal20 mg+lorazpam2 mg
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaid Rajee Hospital
Full name of responsible person
Dr Sevak Hatamian
Street address
Padeghan Street
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice-chancellor for research of Qazvin universityof medical science
Full name of responsible person
Dr Saeed Assefzadeh
Street address
Shahid bahonar Blvd
City
Qazvin
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 Qazvin universityof medical science
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
Qazvin, University of Medical Science
Full name of responsible person
Dr Behname Mahmoodieh
Position
Assitant rezident
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 28 1332 0107
Fax
Email
Bmahmoodieh@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin, university of medical sciencesand health services
Full name of responsible person
Dr Siyamsk Yaghoubi
Position
Assitant professor/anesthesia
Other areas of specialty/work
Street address
Shahid bahonar Blv
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
Email
Siamak.yaghubi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin university of medical sciencesand health services
Full name of responsible person
Dr Sevak Hatamian
Position
Anaesthesia Resident
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
Fax
Email
Sehatamian@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)