The aim of this study is comparison of melatonin and acetaminophen on pain and hemodynamic alterations associated with retrobulbar eye block in cataract surgery.
After taken an informed consent, 180 patients scheduled for cataract surgery with ( ASA-PS)I-III will be recruited in a double-blinded randomized trial(neither patients&researcher know treatment). The patients will be classified to 3 groups. Inclusion criteria: patients aged 50-90 years with( ASA-PS)I- III ,scheduled for elective cataract surgery.
Exclusion criteria: coagulopathy; ongoing treatment with anti coagulant drugs ;Cognition disorders; Alzheimer's disease ;allergy to local anesthetic drugs ;Claustrophia ;chronic cough ; narcotics and opioids addiction; sedative drug users ; Surgeries under general anesthesia ;surgical duration more than one hour and failure of retrobulbar block patients will take melatonin 6 mg (melatonin group) , acetaminophen 500 mg (acetaminophen group ) and placebo(placebo group) orally 60 min before arrival in the operating room .Fentanyl 0.5 μg/kg IV is administered before the retrobulbar block. Hemodynamic variables ( HR،SBP،DBP،MAP،O2 Sat )are measured .Score of pain is recorded according to the VAS before and 1 min after block ,5 min after and end of operation ,and in the recovery room.
Complications like nausea, vomiting, low oxygen saturation level are noted and treated.
Fentanyl 0.5 μg/kg will be administered IV during the surgery if the patients complain of pain with VAS more than 3.Data will be recorded in a questionnaire
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012315963N4
Registration date:2015-03-11, 1393/12/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-03-11, 1393/12/20
Registrant information
Name
Soudabeh Haddadi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13332383068
Email address
so_haddadi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor for Research of Guilan University
Expected recruitment start date
2015-04-19, 1394/01/30
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of melatonin and acetaminophen on pain and hemodynamic alterations associated with retrobulbar eye block in cataract surgery
Public title
Comparison of melatonin and acetaminophen in cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients aged 50-90 years with( ASA-PS)I- III ,scheduled for elective cataract surgery
Exclusion criteria:coagulopathy; ongoing treatment with anti coagulant drugs ;Cognition disorders; Alzheimer's disease ;allergy to local anesthetic drugs ;Claustrophia ;chronic cough ; narcotics and opioids addiction; sedative drug users ; surgeries under general anesthsia ;surgical duration more than one hour and failure of retrobulbar block
Age
From 50 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
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
Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences, Parastar St., Rasht, IRAN
City
Rasht
Postal code
Approval date
2015-01-05, 1393/10/15
Ethics committee reference number
1930474206
Health conditions studied
1
Description of health condition studied
cataract
ICD-10 code
H25.9
ICD-10 code description
Senile cataract, unspecified
Primary outcomes
1
Description
pain
Timepoint
before and 1 min after block ,5 min after and end of operation ,and in the recovery room
Method of measurement
visual analog scale
2
Description
O2 saturation
Timepoint
before and 1 min after block ,5 min after and end of operation ,and in the recovery room
Method of measurement
pulse oxymetery
3
Description
heart rate
Timepoint
before and 1 min after block ,5 min after and end of operation ,and in the recovery room
Method of measurement
vital signs monitoring device
4
Description
mean arterial pressure
Timepoint
before and 1 min after block ,5 min after and end of operation ,and in the recovery room
Method of measurement
vital signs monitoring device
Secondary outcomes
1
Description
nausia,vomitting
Timepoint
during retrobulbar block ,surgery and recovery
Method of measurement
Obsevation
2
Description
low oxygen saturation level
Timepoint
during retrobulbar block ,surgery and recovery
Method of measurement
vital signs monitoring device
Intervention groups
1
Description
Placebo group will take placebo pill with water orally 60 min before arrival in the operating room
Category
Placebo
2
Description
Melatonin group will take 6 mg melatonin pill with water orally 60 min before arrival in the operating room
Category
Treatment - Drugs
3
Description
Acetaminophen group will take 500 mg acetaminophen pill with water orally 60 min before arrival in the operating room
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Almomenin hospital
Full name of responsible person
Drs Sodabeh Haddadi
Street address
Rasht
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
vice-chancellor for Research
Street address
Guilan University of Medical Sciences, Parastar St., Rasht,Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Drs Sodabeh Haddadi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Amir-Almomenin Hospital, Guilan University of Medical Sciences, Rasht, Iran
City
Rasht
Postal code
Phone
+98 13 3323 8307
Fax
Email
So_Haddadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Drs Sodabeh Haddadi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)