Comparison the effect of Melatonin and Dexmedetomidine on dose requirements of propofol in induction and maintenance of anesthesia by guidance of BIS in femur fracture surgery
Comparison the effect of Melatonin and Dexmedetomidine on dose requirements of propofol in induction and maintenance of anesthesia by guidance of BIS in femur fracture surgery
Design
Double-blind randomized clinical trial
Settings and conduct
In the dexmedetomidine group, after diluting the drug with normal saline in a 50 ml syringe, 1 μg / kg dexmedetomidine is injected within 15 minutes and after induction of anesthesia, 0.5 μg / kg is injected during surgery.
In the melatonin group, 9 mg of melatonin is given sublingually 15 minutes before induction of anesthesia. In the melatonin group, patients receive a normal saline infusion placed on a syringe pump to blind the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Hypersensitivity to propofol, dexmedetomidine or melatonin, Consumption of opium and psychotropic drugs, Consumption of beta blocker History of liver, kidney and cardiovascular failure, Vascular stroke, Neurological diseases, Diabetes Hypothyroidism, Peripheral or central vascular diseases, History of high blood pressure, History of taking anticonvulsant drugs, Pace maker, Duration of operation more than 180 minutes.
Intervention groups
In the dexmedetomidine group, after diluting the drug with normal saline in a 50 ml syringe, 1 μg / kg dexmedetomidine is injected within 15 minutes and after induction of anesthesia, 0.5 μg / kg is injected during surgery.
In the dexmedetomidine group, patients receive a sublingual placebo for blinding 15 minutes before induction of anesthesia.
In the melatonin group, 9 mg of melatonin is given sublingually 15 minutes before induction of anesthesia. In the melatonin group, patients receive a normal saline infusion placed on a pump syringe to blind the study.
Main outcome variables
Sedation, anxiety, pain, nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N103
Registration date:2020-12-23, 1399/10/03
Registration timing:prospective
Last update:2020-12-23, 1399/10/03
Update count:1
Registration date
2020-12-23, 1399/10/03
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
2021-02-18, 1399/11/30
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Melatonin and Dexmedetomidine on dose requirements of propofol in induction and maintenance of anesthesia by guidance of BIS in femur fracture surgery
Public title
Comparison the effect of Melatonin and Dexmedetomidine on dose requirements of propofol in induction and maintenance of anesthesia by guidance of BIS in femur fracture surgeryon
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 21 and 60 years
ASA I ,II
BMI 18-30
Elective tympanomastoidectomy
Exclusion criteria:
Hypersensitivity to propofol, dexmedetomidine or melatonin
Consumption of opium and psychotropic drugs
Consumption of beta blocker
History of liver, kidney and cardiovascular failure
Vascular stroke
Neurological diseases
Diabetes
Hypothyroidism
Peripheral or central vascular diseases
History of high blood pressure
History of taking anticonvulsant drugs
Pace maker
Duration of operation more than 180 minutes
Age
From 21 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is from https://www.sealedenvelope.com/.
To prevent the last allocation from being revealed, 4, 6 and 8 random blocks will be used to assign individuals to groups.
The dark secret envelopes arranged by the study-independent analyzer are returned to the preoperative area by a nurse who is out of the study, and the patient profile sheets are removed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The nurses involved in this study are unaware of the type of intervention. In addition, all patients and authors of this study are unaware of the awakening time, extubation time, variables measured in the recovery room and the order of intervention.
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
2020-06-15, 1399/03/26
Ethics committee reference number
IR.SUMS.MED.REC.1399.172
Health conditions studied
1
Description of health condition studied
Femur Fracture
ICD-10 code
M80.05
ICD-10 code description
Age-related osteoporosis with current pathological fracture, femur
Primary outcomes
1
Description
Sedation
Timepoint
After transfer to the recovery room
Method of measurement
Richmond test
2
Description
Anxiety
Timepoint
The morning of the operation, before entering the operating room. In the recovery room and after full awakening in 30,60,90,120 minutes
Method of measurement
BECk Anxiety Assessment Test
3
Description
Pain
Timepoint
Severity of pain after waking up in the recovery room at 30,60,90,120 minute
The duration of the end of surgery until the extubation
Timepoint
The interval from the end of surgery to the removal of the endotracheal tube
Method of measurement
Observation
2
Description
Duration of recovery
Timepoint
Duration of stay in recovery
Method of measurement
Observation
3
Description
The amount of bleeding
Timepoint
At the end of surgery
Method of measurement
Observation
Intervention groups
1
Description
Intervention group:In the dexmedetomidine group, after diluting the drug with normal saline in a 50 ml syringe, 1 μg / kg dexmedetomidine is injected within 15 minutes and after induction of anesthesia, 0.5 μg / kg is injected during surgery.In the dexmedetomidine group, patients receive a sublingual placebo for blinding 15 minutes before induction of anesthesia.
Category
Prevention
2
Description
Intervention group:In the melatonin group, 9 mg of melatonin is given sublingually 15 minutes before induction of anesthesia. In the melatonin group, patients receive a normal saline infusion placed on a syringe pump to blind the study.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Reza Jouybar
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
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
masihifarzaneh@yahoo.com
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
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 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)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD