Comparison of the effects of dexmethomedin and midazolam on hemodynamic changes during extubation of patients with a history of hypertension candidates for non-emergency orthopedic surgery
Comparison of the effects of dexmethomedin and midazolam on hemodynamic changes during extubation of patients with a history of hypertension candidates for non-emergency orthopedic surgery
Design
This study will be a randomized, single-blind clinical trial with parallel groups in phase 3-2, which will be divided into two groups of 50 people online.
Settings and conduct
In this study, 100 candidates for general anesthesia in Shohada Hospital (Tabriz) will be included in the study and will be randomly divided into two groups with the help of online software. Prior to extubation, patients in the intervention group will be injected with dexmedetomedin and in the control group with midazolam; The data analyzer will be unaware of the type of grouping and will be blind during the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: (1) Patients candidates for orthopedic surgery require general anesthesia (2) History of hypertension with the approval of a cardiologist (3) Use of antihypertensive drugs and non-inclusion criteria: (1) Blood pressure Uncontrolled over (2) patients with difficult intubation (3) pregnant women.
Intervention groups
A total of 100 orthopedic surgery candidates will be included in this study and will be divided into two groups after randomly assigned online. Patients in the intervention group will receive 0.6 mg / kg body weight per hour before the extubation intervention, and patients in the control group will receive midazolam 0.02 mg / kg body weight ten minutes before extubation. Will receive as a bolus
Main outcome variables
Hemodynamic status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N26
Registration date:2022-01-21, 1400/11/01
Registration timing:prospective
Last update:2022-01-21, 1400/11/01
Update count:0
Registration date
2022-01-21, 1400/11/01
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of dexmethomedin and midazolam on hemodynamic changes during extubation of patients with a history of hypertension candidates for non-emergency orthopedic surgery
Public title
Comparison of dexmetomedin and midazolam on hemodynamic changes during extubation of patients with a history of hypertension
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for orthopedic surgery require general anesthesia
History of high blood pressure with the approval of a cardiologist
Taking medications to control high blood pressure
Exclusion criteria:
Uncontrolled high blood pressure
Patients with difficult intubation
Pregnant women
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be placed in one of two groups of midazolam or dexmethomedin, respectively, according to the purification list prepared with the help of Online statistical software (WWW.Randomizer.org). In this software, 100 people will be determined; Then, the patients' details will be entered into this software by entering the study and will be divided into two relevant groups by the software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical consultant will be unaware of the grouping of patients, so he will be blind during the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2021-12-13, 1400/09/22
Ethics committee reference number
IR.TBZMED.REC.1400.920
Health conditions studied
1
Description of health condition studied
Hemodynamic status
ICD-10 code
R03.0
ICD-10 code description
Elevated blood-pressure reading, without diagnosis of hypertension
Primary outcomes
1
Description
Hemodynamic status
Timepoint
Every minute for ten minutes
Method of measurement
A mercury sphygmomanometer will be used to measure blood pressure and a pulse oximeter will be used to measure heart rate.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive dexmedetomedine at a rate of 0.6 mg /kg per hour ten minutes before extubation and their hemodynamic status (blood pressure and heart rate) for one minute every ten minutes after extubation. The load will be measured.
Category
Prevention
2
Description
Control group: Patients will receive 0.02 mg /kg in the form of bolus in the ten minutes before extubation and their hemodynamic status (blood pressure and heart rate) for ten minutes after each extubation. It will be measured once a minute.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Masoud Parish
Street address
Shohada Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 41 3335 5921
Email
Drparishm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Tabriz University of Medical Sciences , Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Shahabi.p@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Parish
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Drparishm@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Parish
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Drparishm@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@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