Comparison of the effect of midazolam with dexmedetomidine before extubation on anesthesia emergence reactions in patients after lumbar disc surgery: a randomized clinical trial study
Comparison of the effect of midazolam with intravenous dexamethasone before extubation on anesthesia withdrawal reactions in patients after lumbar disc surgery
Design
The present study is a double-blind randomized clinical trial.
Settings and conduct
In the present study, the drug injection will be 20 minutes before the start of the extubation process. Induction of anesthesia and induction will be the same in all patients and maintenance of anesthesia in all patients will be by TIVA (propofol + remifentanil). Doses of dexmedetomidine and midazolam will be injected in the study groups after surgery and 20 minutes before extubation while the patient is still in the prone position.
Participants/Inclusion and exclusion criteria
All patients who are candidates for lumbar disc surgery referred to Peymaniyeh Hospital in Jahrom in 1401-1400, aged between 18 and 65 years, who are fully satisfied with the study; Do not have a history of smoking or alcohol; do not have uncontrolled cardiovascular disease, diabetes, or obesity; have no history of hypertension, asthma or chronic obstructive pulmonary disease.
Intervention groups
Patients will be randomly divided into three groups A (receiving midazolam at a dose of 0.20 mg / kg / h) (39) and B (receiving dexmedetomidine at a dose of 1 μg / kg) (39) And c will be used as the control group (placebo = normal saline).
Main outcome variables
After drug injection, systolic and diastolic blood pressure and mean arterial and heart rate, before and after extubation will be recorded. In the recovery phase until the patient is discharged from the care unit after anesthesia, vital signs will be recorded before extubation, 5 minutes after extubation, when entering the recovery, 5 minutes after entering the recovery and 10 minutes after recovery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050976N2
Registration date:2021-05-25, 1400/03/04
Registration timing:registered_while_recruiting
Last update:2021-05-25, 1400/03/04
Update count:0
Registration date
2021-05-25, 1400/03/04
Registrant information
Name
navid kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
k.navid@juma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of midazolam with dexmedetomidine before extubation on anesthesia emergence reactions in patients after lumbar disc surgery: a randomized clinical trial study
Public title
midazolam with dexmedetomidine for extubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for lumbar disc surgery referred to Peymaniyeh Hospital in Jahrom
Complete satisfaction to participate in the study
No smoking and alcohol
Lack of uncontrolled cardiovascular disease and diabetes and obesity
No history of hypertension, no history of asthma and chronic obstructive pulmonary disease
Age between 18 and 65 years
Exclusion criteria:
occurrence of symptoms indicating an airway problem
Risk factor for aspiration
Recent airway infection
Bmi above 30
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients participating in the present study will be divided into three groups of dexmedetomidine, midazolam and control by throwing dice
Blinding (investigator's opinion)
Double blinded
Blinding description
After preparation, the drugs are placed in a special box in a syringe and delivered to the relevant anesthesiologist. The anesthesiologist is already aware of the grouping of studies and the safety of injecting all three available box models (three study groups) but does not know the contents of the received box. There will be no difference in how the contents of the three study boxes are injected. Only the anesthesia supervisor will be notified of the coding of the boxes. The outcome assessor will have no information about the type of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of jahrom University of Medical Sciences
Street address
Jahrom, Motahhari Blvd, Jahrom University of Medical Sciences
City
jahrom
Province
Fars
Postal code
7167758256
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.JUMS.REC.1399.140
Health conditions studied
1
Description of health condition studied
Lumbar disc surgery
ICD-10 code
M43.06
ICD-10 code description
Spondylolysis, lumbar region
Primary outcomes
1
Description
vital signs
Timepoint
Before the extubation, 5 minutes after extubation, when entering recovery room, 5 and 10 minutes after recovery
Method of measurement
Monitoring device
Secondary outcomes
1
Description
Occurrence of cough
Timepoint
During and after extubation
Method of measurement
Likert scale for measuring cough (no cough = 0, mild cough = 1, moderate cough = 2 and severe cough = 3).
2
Description
nausea and vomiting
Timepoint
During and after extubation
Method of measurement
Likert spectrum for measuring nausea (no nausea = 0, no nausea = 1 and no vomiting = 2)
Intervention groups
1
Description
Intervention group 1: Patients in group 1 will receive midazolam 20 minutes before extubation at a dose of 20. mg per kg of body weight.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in group 2 will receive dexmedetomidine 20 minutes before extubation at a dose of 1 mg per kg body weight.
Category
Treatment - Drugs
3
Description
Control group: Patients in the control group will receive normal saline 20 minutes before extubation.
Shahid Motahari Boulevard, Jahrom University of Medical Sciencesو Jahrom
City
Shiraz
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
navidkalani@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Expert in Clinical Research Development Center
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahad ave. peimanieh hospital
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 5433 6085
Fax
Email
k.navid@juma.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Expert in Clinical Research Development Center
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahad ave. peimanieh hospital
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 5433 6085
Fax
Email
k.navid@juma.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Expert in Clinical Research Development Center
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahad ave. peimanieh hospital
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 5433 6085
Fax
Email
k.navid@juma.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
At the reasonable request of the person in charge of this project, the data obtained from the project will be available.
When the data will become available and for how long
After the publication of the article or dissertation resulting from this research
To whom data/document is available
People who send their request to the person in charge of this project.
Under which criteria data/document could be used
After the publication of the article or dissertation of this study, the data of this research will be available to researchers who intend to conduct meta-analytical review studies.
From where data/document is obtainable
If the request is sent by email to the person in charge of this research, the request will be reviewed.
What processes are involved for a request to access data/document
If all the collaborating researchers in this research are approved and the research assistant is approved, the data will be provided to the applicant.