Protocol summary
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Study aim
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Comparison of the effect of Labetalol and Remifentanil and Dexmedetomidine in control of bleeding during Craniotomy
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Design
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The study will be double blind and clinical trial.90 patients will be randomly divide into 3 groups. The groups are parallel. The trial phase is 3.
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Settings and conduct
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Patients with Craniotomy in Valiasr hospital in Arak are divided into 3 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age 18 to 75 years, ASA Class One and Two,no coagulation disorders, no history of cardiovascular disease, not addicted to opioids, body mass index more than 35, candidate patients for craniotomy
Exclusion criteria: dissatisfaction with surgery, platelet count less than 150 thousand
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Intervention groups
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Intervention group 1: A bolus dose of 10 millilitre of normal saline is administered for 10 minutes and then remifentanil is infused at a dose of 0.1 micro gram per kilogram per minute until the end of surgery (GlaxoSmithKline Company (London - England).
Intervention group: 2: 1 micro gram in kilogram Dexmedetomidine will be infused for 10 minutes as the initial dose followed by 0.4 to 0.8 micro gram in kilogram in hours to maintain the infusion dose. (Dexmedetomidine used by Elixir Company - Iran)
Intervention group 3: 0.25 milligram in kilogram Labetalol intravenously as the initial dose is slow and infused within 10 minutes, followed by 1-2 milligram in kilogram intravenously to maintain the infusion dose. (Kern Pharma SL - Spain)
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Main outcome variables
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Surgeon satisfaction, bleeding, mean hemoglobin
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:
IRCT20141209020258N167
Registration date:
2021-10-14, 1400/07/22
Registration timing:
prospective
Last update:
2021-10-31, 1400/08/09
Update count:
1
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Registration date
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2021-10-14, 1400/07/22
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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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2021-10-23, 1400/08/01
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Expected recruitment end date
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2022-10-23, 1401/08/01
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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 of the effect of Labetalol and Remifentanil and Dexmedetomidine in control of bleeding during Craniotomy
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Public title
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Comparison of the effect of Labetalol and Remifentanil and Dexmedetomidine in control of bleeding during head surgery
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18 to 75 years
ASA Class One and Two
No coagulation disorders
No history of cardiovascular disease
Proper control of blood pressure
Absence of pregnancy
Not addicted to opioids
Body mass index more than 35
Candidate patients for craniotomy
Exclusion criteria:
Dissatisfaction
Existence of allergy to the studied drugs
Platelet count less than 150 thousand
Family history of thromboembolism
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be allocated into 3 groups using a permuted balanced block randomization method with the size of blocks 3 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In terms of patient blindness, the intern is responsible for completing information does not know the groupings, and general anesthesia and drug injections are performed by an anesthesiologist.
Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping. The intern is unaware of the drugs prescribed in each group and the anesthesiologist prepares the drugs and provides them to the intern. Also, the patients do not know about their group.
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Placebo
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Not 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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2021-06-13, 1400/03/23
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Ethics committee reference number
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IR.ARAKMU.REC.1400.052
Health conditions studied
1
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Description of health condition studied
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Craniotomy
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ICD-10 code
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I60
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ICD-10 code description
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Nontraumatic subarachnoid hemorrhage
Primary outcomes
1
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Description
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Surgeon satisfaction
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Timepoint
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After surgery
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Method of measurement
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Question from the surgeon
2
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Description
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Bleeding
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Timepoint
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During surgery
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Method of measurement
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observation
3
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Description
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Mean hemoglobin
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Timepoint
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Before and 12 hours after surgery
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Method of measurement
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Hemoglobin blood test(CBC diff)
Intervention groups
1
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Description
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ntervention group 1: A bolus dose of 10 millilitre of normal saline is administered for 10 minutes and then remifentanil is infused at a dose of 0.1 micro gram per kilogram per minute until the end of surgery (GlaxoSmithKline Company (London - England).
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Category
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Treatment - Drugs
2
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Description
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Intervention group: 2: 1 micro gram in kilogram Dexmedetomidine will be infused for 10 minutes as the initial dose followed by 0.4 to 0.8 micro gram in kilogram in hours to maintain the infusion dose. (Dexmedetomidine used by Elixir Company - Iran)
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Category
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Treatment - Drugs
3
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Description
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Intervention group 3: 0.25 milligram in kilogram Labetalol intravenously as the initial dose is slow and infused within 10 minutes, followed by 1-2 milligram in kilogram intravenously to maintain the infusion dose. (Kern Pharma SL - Spain)
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Category
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Treatment - Drugs
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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Vice chancellor for research, Arak 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available