Randomized double-blinded clinical trial: The effect of premedication with Valiflore on preoperative anxiety compared with placebo in patients undergoing elective laparoscopic cholecystectomy
The purpose of this clinical trial is the evaluation of the effect of premedication with Valiflore compared with placebo on preoperative anxiety in patients undergoing elective laparoscopic cholecystectomy.
This investigation is a double-blinded randomized clinical trial on eighty patients aged 20–55 years; classified as American Society of Anesthesiologists physical status I and II who were undergoing elective surgical laparoscopic cholecystectomy. Patients with a history of anxiety and other mental disorders, those consuming antidepressant, sedative, analgesic and anti-epileptic drugs and patients with numerical rating scale for anxiety less than one, were excluded from the study.
Patients were randomly divided into two groups control (n= 40) and intervention (n=40) using a computer generated randomization list. Both the interventionist and the patients were blinded to group assignment. Two hours before surgery, patients are brought to a quiet room in the operating room. Patients in the control group receive a placebo tablet and patients in the intervention group receive a Valiflore tablet orally two hours before surgery. The placebo and active form of drug are identical in appearance. Ramsey Sedation Scale and Numeric Rating Scale are measured before, 15 minutes, 30 minutes, 60 minutes, 90 minutes and 120 minutes after administration of premedication and Digit Symbol Substitution Test is measured 30 minutes and 90 minutes after extubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404115175N13
Registration date:2014-05-18, 1393/02/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-18, 1393/02/28
Registrant information
Name
Ali Movafegh
Name of organization / entity
Dr. Shariati Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2373
Email address
movafegh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-05-19, 1393/02/29
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized double-blinded clinical trial: The effect of premedication with Valiflore on preoperative anxiety compared with placebo in patients undergoing elective laparoscopic cholecystectomy
Public title
The effect of premedication with Valiflore on preoperative anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients at the age of 20-55; American Society of Anesthesiologists class I, II; Patients undergoing surgical laparoscopic cholecystectomy.
Exclusion criteria: Patients with a history of anxiety disorders and other mental disorders; Patients with a drug history of sedative drugs; Analgesic; Anti-depressant and anti-seizure; Patients with Numerical Rating Scale for anxiety less than 1.
Age
From 20 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Committee, Faculty of Medicine
Street address
Faculty of Medicine, Tehran University of Medical Sciences and Health Care
City
Tehran
Postal code
Approval date
2012-12-20, 1391/09/30
Ethics committee reference number
130/2366/د/91
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before administration of premedication, 15 minutes, 30 minutes, 60 minutes, 90 minutes and 120 minutes after administration of premedication
Method of measurement
Numeric Rating Scale
Secondary outcomes
1
Description
Sedation
Timepoint
Before administration of premedication, 15 minutes, 30 minutes, 60 minutes, 90 minutes and 120 minutes after administration of premedication
Method of measurement
Ramsey Sedation Scale
2
Description
Duration of anesthesia
Timepoint
First minute of anesthetia, first minute of recovery
Method of measurement
Time in minute
3
Description
Duration of surgery
Timepoint
First minute of starting surgery, minute of finishing surgery
Method of measurement
Time in minute
4
Description
Duration of departure time of recovery
Timepoint
First minute of entering recovery, minute of departure of recovery
Method of measurement
Time in minute
Intervention groups
1
Description
Patients in the intervention group (number=40) receive a valiflore tablet orally 2 hours before the surgery.
Category
Prevention
2
Description
Patients in the control group (number=40) receive a placebo tablet orally 2 hours before the surgery.
placebo tablet is similar to the original drug in color, odor and shape.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Ali Shariati Hospital
Full name of responsible person
Dr. Ali Movafegh
Street address
Dr. Ali Shariti Hospital, North karegar Ave, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Shahin Akhoundzade
Street address
Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
Dep. of Anesthesiology, Dr. Ali Shariti Hospital, North karegar Street, Tehran, Iran
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2397
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
Anesthesiology Department, Dr. Ali Shariti Hospital, North karegar Street, Tehran, Iran
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2397
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
Anesthesiology Department, Dr. Ali Shariti Hospital, North karegar Street, Tehran, Iran
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2397
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)