Protocol summary
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Study aim
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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
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Design
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Double-blind randomized clinical trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Sedation, anxiety, pain, nausea and vomiting
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141009019470N103
Registration date:
2020-12-23, 1399/10/03
Registration timing:
prospective
Last update:
2025-05-18, 1404/02/28
Update count:
1
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Registration date
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2020-12-23, 1399/10/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-02-18, 1399/11/30
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Expected recruitment end date
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2021-04-20, 1400/01/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 21 years old to 60 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Data analyser
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-06-15, 1399/03/26
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Ethics committee reference number
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IR.SUMS.MED.REC.1399.172
Health conditions studied
1
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Description of health condition studied
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Femur Fracture
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ICD-10 code
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M80.05
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ICD-10 code description
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Age-related osteoporosis with current pathological fracture, femur
Primary outcomes
1
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Description
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Sedation
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Timepoint
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After transfer to the recovery room
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Method of measurement
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Richmond test
2
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Description
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Anxiety
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Timepoint
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The morning of the operation, before entering the operating room. In the recovery room and after full awakening in 30,60,90,120 minutes
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Method of measurement
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BECk Anxiety Assessment Test
3
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Description
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Pain
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Timepoint
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Severity of pain after waking up in the recovery room at 30,60,90,120 minute
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Method of measurement
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Visual analog Scale
4
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Description
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Nausea and Vomiting
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Timepoint
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After transferring patients to the recovery room
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Method of measurement
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PONV score: 0 = no emetic symptoms, 1 = nausea, 2 = vomiting
Secondary outcomes
1
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Description
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The duration of the end of surgery until the extubation
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Timepoint
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The interval from the end of surgery to the removal of the endotracheal tube
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Method of measurement
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Observation
2
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Description
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Duration of recovery
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Timepoint
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Duration of stay in recovery
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Method of measurement
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Observation
3
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Description
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The amount of bleeding
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Timepoint
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At the end of surgery
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Method of measurement
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Observation
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Its against our policy.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available