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A Comparison of the effect of dexmedetomidine and remifentanil on analgesia and respiratory parameters in patients undergoing stereotactic brain biopsy

Protocol summary

Study aim
Comparison of the effect of dexmedetomidine and remifentanil on sedation analgesia and respiratory parameters in patients undergoing stereotactic biopsy
Design
The aim was to compare the efficacy of dexmedetomidine and remifentanil on sedation, hemodynamic changes, analgesia, respiration, and recovery during stereotactic brain biopsy. 40 patients are randomly divided into two groups based on admission criteria. Time to reach sedation scale (Ramsey 2–4), hemodynamic and respiratory changes, analgesia, and recovery from sedation are recorded.The person injecting and recording the information does not know the grouping of patients and the study is done as a blind.
Settings and conduct
Preoperative assessment, standard monitoring, G18 catheter, 2 liters of oxygen per minute, and the necessary equipment in difficult airways, the necessary tools for rapid opening of the form. Installation of stereotactic fram under local anesthesia of the scalp with 20 cc of 1.5% lidocaine and 50 mic /IV fentanyl and MRI. Group D: Intravenous dexmedetomidine 0.5 mic / kg loading dose: for 10 minutes and then 0.5 mic / kg / h by infusion pump Group R: Remifentanil, 1mic / kg IV bolus then 0.05 -0.2mic / kg / min IV by infusion pump With the aim of sedation with Ramssy 2-4. Recording of hemodynamic and unwanted complications during the procedure. Discontinue injection in case of Brady Penne (RR <8), Apnea> 15 seconds, SPO2 <94%.
Participants/Inclusion and exclusion criteria
Inclusion: 18-50 years old, normal liver and kidney , no drug addiction. Exclusion: comorbidities, brainstem lesions, intubated patients.
Intervention groups
Remifentanil (Mylan): 1mic/kg intravenous bolus and then 0.05 -0.2 mic/kg/ minute by infusion pump . Dexmedetomidine (elixir): 0.5 mic/ kg/IV for 10 minutes and then 0.5 micr/kg/ hour by infusion pump
Main outcome variables
saturation . ,Seadation ,recovery,analgesia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210415050983N2
Registration date: 2022-01-09, 1400/10/19
Registration timing: registered_while_recruiting

Last update: 2022-01-09, 1400/10/19
Update count: 0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Sogol Asgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8836 3185
Email address
drasgari98429@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the effect of dexmedetomidine and remifentanil on analgesia and respiratory parameters in patients undergoing stereotactic brain biopsy
Public title
A Comparison of the effect of dexmedetomidine and remifentanil on analgesia and respiratory parameters in patients undergoing stereotactic brain biopsy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18-50 years old candidate for stereotactic Patients with supratentorial lesions with or without hydrocephalus No dysfunction of the liver and kidneys No drug addiction Consent to participate in the study
Exclusion criteria:
BMI >35 or<16 mental disorder Uncontrolled epilepsy Alcohol and drug abuse Having a comorbid condition such as high blood pressure History of chronic pain Patients with brainstem lesions Intubated patients
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
En Permuted Randomized Blocks :In this method, 10 random blocks are generated by computer. Each block includes 5 people in the intervention group and 5 people in the control group. The order of these people is randomly arranged by computer and people are assigned to groups in the same way. At the end of each block, a new block of 10 is produced and this process will continue until the final sample volume is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
Forms with numbers 1 and 2 are used in packaged envelopes to group patients, which are given to patients randomly and patients do not know about the envelopes. After entering the envelope operating room by the anesthesiologist in charge of the patient Opened and according to the intervention group, the drug that was prepared in advance is given to the clinical caregiver for injection. The clinical caregiver is not aware of the grouping. The evaluator and recorder of the results and the person analyzing the data are also unaware of the grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice for Research and Technology, Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yemen Street, Shahid Shahriari Square
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.657

Health conditions studied

1

Description of health condition studied
Stereotactic biopsy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Hemodynamic parameters
Timepoint
Every 5 minutes from the moment you enter the operating room
Method of measurement
monitoring

2

Description
Respiratory parameters
Timepoint
Every 5 minutes from the moment you enter the operating room
Method of measurement
monitoring

3

Description
Seadation
Timepoint
Every 5 minutes from the moment you enter the operating room
Method of measurement
Ramssy Criteria

4

Description
Analgesia
Timepoint
Every 5 minutes from the moment you enter the operating room
Method of measurement
VAS criteria

5

Description
Recovery from sedation
Timepoint
Every 10 minutes after the procedure
Method of measurement
Aldert criteria

Secondary outcomes

empty

Intervention groups

1

Description
First, under local anesthesia of the scalp with 20 cc of 1.5% lidocaine and 50 micrograms of intravenous fentanyl, a stereotactic form is installed for the patient and the patient is transferred to radiology for MRI. Then 2 liters of oxygen per minute with a mask, 5 cc of normal saline per hour and 0.003 mg per kg of intravenous midazolam are given. Group D receive intravenous dexmedetomidine at the rate of 0.5 micrograms per kg per 10 minutes for 10 minutes. Then 0.5 micrograms per kilogram per hour is given by the infusion pump during the procedure.
Category
N/A

2

Description
First, under local anesthesia of the scalp with 20 cc of 1.5% lidocaine and 50 micrograms of intravenous fentanyl, a stereotactic form is installed for the patient and the patient is transferred to radiology for MRI. Then 2 liters of oxygen per minute with a mask, 5 cc of normal saline per hour and 0.003 mg per kg of intravenous midazolam are administered. Group R Remifentanil 1 microgram per kilogram of bolus and then 0.05 to 0.2 micrograms per kilogram. Receives grams per minute by infusion pump.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tajrish Shohada Hospital
Full name of responsible person
Faranak Behkaz
Street address
Valiasr St., Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Faranak.behnaz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice for Research and Technology of Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yemen Street, Shahid Shahriari Square
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
ms@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sogol Asgari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
South Kargar St. Kamali St. Special Loghman Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
drasgari98429@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faranak Behnaz
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr St. Tajrish Square (Quds)
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Faranak.behnaz@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sogol Asgari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
South Kargar St. Kamali St. Special Loghman Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 912 845 1648
Email
drasgari98429@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
En All data(questionnaire and the Excel file) can be shared after identifying individuals.
When the data will become available and for how long
Start access 6 months after printing results
To whom data/document is available
En Researchers working in academic institutions
Under which criteria data/document could be used
En If the study is conducted in a larger area between several hospitals
From where data/document is obtainable
En Email: drasgari98429@gmail.com Phone : 09127421711 Mrs. Dr. Sogol Asgari
What processes are involved for a request to access data/document
En After identifying the people, the questionnaire and the Excel file will be sent via e-mail within a week.
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