The Effect of Melatonin on Pneumatic Tourniquet Ischemia Reperfusion Injury in Lower Extremity Orthopedic Operation
Design
A double-blind randomized clinical trial
Settings and conduct
Patients in melatonin group receive 10 mg oral melatonin tablets the night before surgery and 2 hours before surgery and patients in the control group receive placebo orally the night before surgery and 2 hours before surgery. Melantonin and placebo tablets are given by a person who is unaware of the study groups the night before surgery and before the patient enters the operating room.
The person who is responsible for collecting the data in the operating room and recovery room was also blinded to the study.
Laboratory experts and statisticians responsible for data analysis have also been blinded to the study
Participants/Inclusion and exclusion criteria
Inclusion criteria:ASA Class I, II Age range 18-65 years Patients undergoing lower limb orthopedic surgery using tourniquet Morning schedule.
Exclusion criteria: BMI> 30 kg/m2, Liver disorders ,Patients with severe renal failure ,Patients with metabolic acidosis, Patients with congestive heart failure, Blood transfusion ,smoking ,alcohol consumption, Pregnancy or breastfeeding, Patients taking any anti-oxidant, Drug Allergies ,Contraindication of Spinal Anesthesia, Mental disorders which are require drug therapy and analgesics.
Intervention groups
Intervention group: Patients in melatonin group receive 10 mg oral melatonin tablets the night before surgery and 2 hours before surgery.
Control group: Patients receive placebo orally the night before surgery and 2 hours before surgery.
Main outcome variables
Serum levels of superoxide dismutase, Serum levels of malondialdehyde,Sedation Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N87
Registration date:2019-08-26, 1398/06/04
Registration timing:prospective
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-11, 1398/06/20
Expected recruitment end date
2019-12-11, 1398/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of Melatonin on Pneumatic Tourniquet Ischemia Reperfusion Injury in Lower Extremity Orthopedic Operation
Public title
The Effect of Melatonin on Pneumatic Tourniquet Ischemia Reperfusion Injury in Lower Extremity Orthopedic Operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA Class I, II
Age range 18-65 years
Patients undergoing lower limb orthopedic surgery using tourniquet
Morning schedule
Exclusion criteria:
BMI> 30 kg/m2
Liver disorders
Patients with severe renal failure
Patients with metabolic acidosis
Patients with congestive heart failure
Blood transfusion
smoking
alcohol consumption
Pregnancy or breastfeeding
Patients taking any anti-oxidant
Drug Allergies
Contraindication of Spinal Anesthesia
Mental disorders which are require drug therapy and analgesics
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to each of the study groups based on the randomization table obtained from Randomization.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
Melatonin and placebo tablets are given by a person who is unaware of the study groups the night before surgery and before the patient enters the operating room.
The person who is responsible for collecting the data in the operating room and recovery room was also blinded to the study.
Laboratory experts and statisticians responsible for data analysis have also been blinded to the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2019-01-09, 1397/10/19
Ethics committee reference number
IR.SUMS.MED.REC.1397.429
Health conditions studied
1
Description of health condition studied
Orthopedic surgery of the lower extrimites
ICD-10 code
S82.201A
ICD-10 code description
Unspecified fracture of shaft of right tibia, initial encounter for closed fracture
Primary outcomes
1
Description
Serum levels of superoxide dismutase
Timepoint
The night before surgery, pre-medication or placebo are taken immediately before spinal anesthesia and 30 minutes after tourniquet inflatation, then 15 minutes after tourniquet removal for measuring superoxide dismutase.
Method of measurement
Enzyme kits
2
Description
Serum levels of malondialdehyde
Timepoint
The night before surgery, pre-medication or placebo are taken immediately before spinal anesthesia and 30 minutes after tourniquet inflatation, then 15 minutes after tourniquet removal for measuring superoxide dismutase.
Method of measurement
Enzyme kits
Secondary outcomes
1
Description
Sedation Score
Timepoint
It is measured before melatonin administration and at intervals of 5,10,20,30,45,60,80 minutes after melatonin administration.
Method of measurement
Ramsey Score
2
Description
Patient satisfaction
Timepoint
At the end of the operation
Method of measurement
Likert criteria
Intervention groups
1
Description
Intervention group: Intervention group: Patients in melatonin group receive 10 mg oral melatonin tablets the night before surgery and 2 hours before surgery.
Category
Prevention
2
Description
Control group: Control group: Patients receive placebo orally the night before surgery and 2 hours before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Sima Razmoji
Street address
Shahid Chamran Hospital,Shahid Chamran Boulevard,
City
Shiraz
Province
Fars
Postal code
۱۵۶۴۴-۷۱۹۴۸
Phone
+98 71 3624 0101
Email
chamranam@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sima Razmjooie
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
razmjooiesima@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Jouybar
Position
Cardio-anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
joybarr@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available