The effects of melatonin on anxiety and pain scores of patients, intraocular pressure and operating conditions during cataract surgery under topical anesthesia
Objective: To evaluate the effects of melatonin premedication on anxiety and pain scores of
patients, operating conditions and intraocular pressure during cataract surgery under topical
anesthesia. Methods: A randomized controlled trial was carried out at a teaching hospital. Sixty patients were randomly assigned to receive either sublingual melatonin 3 mg (n =30) or placebo (n=30) 60 minutes before surgery. Verbal anxiety scores and verbal pain scores, heart rate, systolic and diastolic blood pressure, intraocular pressure and quality of operative conditions were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102223051N3
Registration date:2011-04-13, 1390/01/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-13, 1390/01/24
Registrant information
Name
Marzieh Khezri
Name of organization / entity
Qazvine University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6376
Email address
mkhezri@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor for research, Qazvin university of medical sciences and health services
Expected recruitment start date
2009-09-17, 1388/06/26
Expected recruitment end date
2010-06-19, 1389/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of melatonin on anxiety and pain scores of patients, intraocular pressure and operating conditions during cataract surgery under topical anesthesia
Public title
The effects of melatonin on anxiety and pain scores of patients, intraocular pressure and operating conditions during cataract surgery under topical anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 25–80 years, scheduled for elective cataract surgery with intraocular lens implantation using phacoemulsification under topical anesthesia with an ASA physical status classification I–III. Exclusion criteria: patients with sleep disorders, autoimmune disease, diabetes, depressive disorder or expected compliance problems (known psychiatric disease), epilepsy, leukemia, insufficient pupillary dilation, nystagmus, deafness, allergy to the study drugs, ongoing treatment with hypnotics or psychotropic drugs (including opioids) within a week of admission, daily analgesic treatment, ß blockers, Coumadin derivates and those who could not tolerate Shioetz tonometer during IOP measurement.
Age
From 25 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences & Health Services
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2009-07-20, 1388/04/29
Ethics committee reference number
28/20/4012
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
Y47
ICD-10 code description
Complications of medical and surgical care
Primary outcomes
1
Description
anxiety
Timepoint
before premedication (T1), sixty minutes after premedication, on arrival in the operating room (T2), during the operation period (T3) and postoperatively
Method of measurement
VAS (verbal anxiety score)
2
Description
intraocular pressure
Timepoint
before premedication (T1), and postoperatively
Method of measurement
Shioetz tonometer
3
Description
pain
Timepoint
before premedication (T1), 60 minutes after premedication, on arrival to the OR (T2), five minutes after the start of surgery (T3), and postoperatively before discharging the patient from the recovery room (T4)
Method of measurement
Verbal pain score
Secondary outcomes
1
Description
arterial blood pressure
Timepoint
before premedication (T1), sixty minutes after premedication, on arrival in the operating room (T2), during the operation period (T3) and postoperatively before discharging the patient from the recovery room (T4)
Method of measurement
noninvasive measurement of blood pressure
2
Description
heart rate
Timepoint
before premedication (T1), sixty minutes after premedication, on arrival in the operating room (T2), during the operation period (T3) and postoperatively before discharging the patient from the recovery room (T4)
Method of measurement
electrocardiogram
Intervention groups
1
Description
sublingual melatonin 3 mg 60 minutes before surgery
Category
Prevention
2
Description
sublingual placebo tablet 60 minutes before surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali Hospital
Full name of responsible person
Professor of Anesthesia
Street address
Kosar hospital, Taleghani street
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice-chancellor for research of Qazvin university of medical sciences
Full name of responsible person
Dr. Saeed Assefzadeh
Street address
Shahid Bahonr 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 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
Qazvin university of medical sciences and health services
Full name of responsible person
Dr. Marzieh Beigom Khezri
Position
assisttant professor of Anesthesia
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 28 1222 2452
Fax
Email
mkhezri@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin university of medical sciences and health services
Full name of responsible person
Dr. Marzieh beigom Khezri
Position
assistant professor of anesthesia
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 28 1222 2452
Fax
Email
MKHEZRI@QUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)