Protocol summary
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Study aim
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Comparing the efficacy of propofol-remifentanil with propofol-dexmedetomidine in reducing pain after awake craniotomy
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Design
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Phase 3 randomized controlled, open-labeled clinical trial with parallel groups, of 150 patients. For randomization, the random number table provided by graphpad.com is used.
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Settings and conduct
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This clinical trial will be conducted on eligible patients in the neurosurgery operating room of Sinai Hospital (Tehran University of Medical Sciences).Patients will randomly assigned to one of the two study groups and receive the desired intervention.The intensity of pain, amount of sedation, and total dose of propofol will be evaluated during surgery and recovery.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:The patient should be a candidate for craniotomy surgery using the sleep-awake-asleep method;The patient does not have a previous craniotomy history;The patient does not have a contraindication for full anesthesia;The patient's age is between20 and50years;The patient does not have a history of allergy to any of the drugs under study.
Exclusion criteria:In addition to craniotomy, the patient needs to perform another surgery at the same time;Pregnancy;Breast feeding;The patient has simultaneously heart, renal or liver failure;Severe obesity;
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Intervention groups
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Intervention group: (dexmedetomidine infusion with a LD of 1 μg/kg/h for 15 minutes and then a MD of 0.2 μg/kg/h)
Control group: (propofol1% infusion with a LD of 250 μg/kg/min for 15 minutes and then a MD of 50 μg/kg/min) + (remifentanil infusion with a LD of 0.5 μg/kg for 60 seconds and then a MD of 0.1 μg/kg/min)
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Main outcome variables
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Pain intensity based on the VAS scale
General information
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Reason for update
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Change of sample size due to:
Fewer cases in similar studies in this type of surgery in other countries
limitation in patient recruitment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151221025641N5
Registration date:
2023-03-25, 1402/01/05
Registration timing:
prospective
Last update:
2025-03-17, 1403/12/27
Update count:
2
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Registration date
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2023-03-25, 1402/01/05
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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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2023-04-09, 1402/01/20
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Expected recruitment end date
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2023-10-12, 1402/07/20
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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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Comparing the effectiveness of propofol-remifentanil with propofol-dexmedetomidine in reducing pain after awake craniotomy surgery
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Public title
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Comparing the effectiveness of propofol-remifentanil with propofol-dexmedetomidine in reducing pain after awake craniotomy surgery
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The patient should be a candidate for craniotomy surgery using the sleep-awake-asleep method;
The patient does not have a previous craniotomy history;
The patient does not have a contraindication for full anesthesia;
The patient's age is between 20 and 50 years;
The patient does not have a history of allergy to any of the drugs under study.
Exclusion criteria:
In addition to craniotomy, the patient needs to perform another surgery at the same time;
Pregnancy;
Breast feeding;
The patient has simultaneously heart, renal or liver failure;
Severe obesity (BMI>30 kg/m2);
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Age
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From 20 years old to 50 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
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done with the random number table method created by referring to the www.graphpad.com website.
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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 this study, the patient and the person evaluating the VAS scale are unaware of the type of analgesic intervention received during surgery.
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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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2022-05-11, 1401/02/21
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1401.147
Health conditions studied
1
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Description of health condition studied
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Awake craniotomy
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ICD-10 code
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G94
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ICD-10 code description
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Other disorders of brain in diseases classified elsewhere
Primary outcomes
1
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Description
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Pain intensity
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Timepoint
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On 2,6,12,24,48 hours
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Method of measurement
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VAS scale
Secondary outcomes
1
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Description
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Diclofenac suppository dosage required
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Timepoint
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On 2,6,12,24,48 hours
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Method of measurement
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Medical record
2
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Description
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The duration of hospitalization until the patient is able to move
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Timepoint
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The entire length of hospitalization
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Method of measurement
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Medical record
3
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Description
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Nausea and vomiting
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Timepoint
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On 2,6,12,24,48 hours
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Method of measurement
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Patient examination
4
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Description
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Vertigo
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Timepoint
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On 2,6,12,24,48 hours
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Method of measurement
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Patient examination
Intervention groups
1
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Description
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Intervention group: (dexmedetomidine infusion with a LD of 1 μg/kg/h for 15 minutes and then a MD of 0.2 μg/kg/h)
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Category
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Treatment - Drugs
2
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Description
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Control group: (propofol1% infusion with a LD of 250 μg/kg/min for 15 minutes and then a MD of 50 μg/kg/min) + (remifentanil infusion with a LD of 0.5 μg/kg for 60 seconds and then a MD of 0.1 μg/kg/min)
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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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Tehran University of Medical Sciences
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Proportion provided by this source
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30
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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
2
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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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No
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Title of funding source
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Anesthesiology, critical care and pain management research center, Tehran University of Medical Sciences
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Proportion provided by this source
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70
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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