Comparing the efficacy of propofol-remifentanil with propofol-dexmedetomidine in reducing pain after awake craniotomy
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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;
Intervention groups
Intervention group: (propofol1% infusion with a loading dose(LD) of 250 μg/kg/min for 15 minutes and then a maintenance dose(MD) of 50 μg/kg/min) + (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)
Main outcome variables
Pain intensity based on the VAS scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151221025641N5
Registration date:2023-03-25, 1402/01/05
Registration timing:prospective
Last update:2023-03-25, 1402/01/05
Update count:2
Registration date
2023-03-25, 1402/01/05
Registrant information
Name
Parisa Kianpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2660 2854
Email address
pk.pioneer1@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of propofol-remifentanil with propofol-dexmedetomidine in reducing pain after awake craniotomy surgery
Public title
Comparing the effectiveness of propofol-remifentanil with propofol-dexmedetomidine in reducing pain after awake craniotomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
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);
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done with the random number table method created by referring to the www.graphpad.com website.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient and the person evaluating the VAS scale are unaware of the type of analgesic intervention received during surgery.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building, Ghods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1913914435
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.147
Health conditions studied
1
Description of health condition studied
Awake craniotomy
ICD-10 code
G94
ICD-10 code description
Other disorders of brain in diseases classified elsewhere
Primary outcomes
1
Description
Pain intensity
Timepoint
On 2,6,12,24,48 hours
Method of measurement
VAS scale
Secondary outcomes
1
Description
Diclofenac suppository dosage required
Timepoint
On 2,6,12,24,48 hours
Method of measurement
Medical record
2
Description
The duration of hospitalization until the patient is able to move
Timepoint
The entire length of hospitalization
Method of measurement
Medical record
3
Description
Nausea and vomiting
Timepoint
On 2,6,12,24,48 hours
Method of measurement
Patient examination
4
Description
Vertigo
Timepoint
On 2,6,12,24,48 hours
Method of measurement
Patient examination
Intervention groups
1
Description
Intervention group: (propofol1% infusion with a loading dose(LD) of 250 μg/kg/min for 15 minutes and then a maintenance dose(MD) of 50 μg/kg/min) + (dexmedetomidine infusion with a LD of 1 μg/kg/h for 15 minutes and then a MD of 0.2 μg/kg/h)
Category
Treatment - Drugs
2
Description
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)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Reza Shariat Moharari
Street address
Sina hospital; Hasan abad Sq., Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6312 0000
Fax
Email
moharari@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central building, Ghods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1913914435
Phone
+98 21 8163 1000
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
30
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
2
Sponsor
Name of organization / entity
Anesthesiology, critical care and pain management research center
Full name of responsible person
Farhad Etezadi
Street address
Sina hospital, Hasan abad sq., Imam khomeini Ave.
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6312 0000
Email
accpm.rc.tums@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Anesthesiology, critical care and pain management research center, Tehran University of Medical Sciences
Proportion provided by this source
70
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
Tehran University of Medical Sciences
Full name of responsible person
Shima Baniasad
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital, Hasan abad sq., Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6312 0000
Email
shima.baniassad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Shariat Moharari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital, Hasan abad sq., Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6312 0000
Email
moharari@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shima Baniasad
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital, Hasan abad sq., Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6312 0000
Email
shima.baniassad@gmail.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