Comparative evaluation of the effect of Passiflora Incarnata and Melatonine as premedication on the cognitive tests in post operative period of elective surgeries
Given that preoperative anxiety is an important phenomenon. The aim of this project is finding of drugs that can reduce the anxiety, but does not affect the recovery time after surgery or would not produce cognitive impairment.
For this purpose, in a double blind randomized clinical trial, the effect of prescribing Passiflora Incarnata and Melatonin as premedication drugs on the postoperative cognitive tests in patients with elective surgery will be evaluated. So, 52 patients 20-60 years old, ASA I & II physical class, candidated for elective surgery without history of diabetes mellitus & pregnancy will be divided randomly into two equal groups. For premedication in patients of group (1) Passiflora Incarnata and in group (2), Melatonin one hour before the surgery will be prescribed. Cognitive condition and level of sedation with standard tests before, after 60 min and after the awakening of patients from anesthesia will be evaluated and compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110824909N5
Registration date:2015-12-20, 1394/09/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-20, 1394/09/29
Registrant information
Name
Faranak Rokhtabnak
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6267
Email address
rolhtabnak.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effect of Passiflora Incarnata and Melatonine as premedication on the cognitive tests in post operative period of elective surgeries
Public title
Evaluation of the effect of Passiflora Incarnata and Melatonine in post operative cognitive disfunction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists(ASA) 1&2 ; age range of 20-60; minor to moderate surgery under general anesthesia
Exclusion criteria:
Age lower than 20 and higher than 60; diabetic patients; hypertension; depression & anti depressant drug consumption; pregnant & Lactating women; seizure & anti-convulsive drug consumption
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization with enveloped packets
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
1593748711
Approval date
2015-09-19, 1394/06/28
Ethics committee reference number
IR.IUMS.REC.1394.9111174013
Health conditions studied
1
Description of health condition studied
Post operative cognitive disorders
ICD-10 code
F13
ICD-10 code description
Mental and behavioural disorders due to use of sedatives or hypnotics
Primary outcomes
1
Description
Post operative cognitive disorders
Timepoint
Before intervention, one hour after intervention, discharge time from recovery room
Method of measurement
Digit Symbol Substitutional Test
Secondary outcomes
1
Description
Preoperative sedation score
Timepoint
One hour after intervention
Method of measurement
Ramsey sedation score
Intervention groups
1
Description
Intervention group1: 1000 mg Passiflora Incarnata orally one hour before operation in single dose, Natiris company
Category
Prevention
2
Description
Intervention group2: 6 mg Melatonin orally one hour before surgery one hour before operation in single dose, USA Pharmavite company (Nature Made)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozghar Hospital
Full name of responsible person
Seyedeh Somayeh Seyed Alizadeh Ganji
Street address
Firoozgar hospital, Behafarin St. Karim Khan Av.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research & Technology, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
5th floor, Central bulding, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research & Technology, Iran 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
Iran University of Medical Science
Full name of responsible person
Seyedeh Somayeh Seyed Alizadeh Ganji
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Firoozghar Hospital, Behafarin St. Karimkhan Av.
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1000
Fax
Email
dr.alizadeh61@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Franak Rokhtabnak
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Firoozghar Hospital, Behafarin St. Karimkhan Av.
City
Tehran
Postal code
1593748711
Phone
+98 21 8894 6762
Fax
Email
rkhtbnk@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Seyedeh Somayeh Seyed Alizadeh Ganji
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Firoozghar Hospital, Behafrin St. Karimkhan Av.
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1000
Fax
Email
dr.alizadeh61@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)