Comparative study of the effect of dexmedetomidine and remifentanil on the quality of endotracheal intubation with videolaryngoscope in patients with neck trauma
Determining the effect of sedation under the influence of dexmedetomidine and remifentanil during endotracheal intubation with videolaryngoscope glideoscope in patients with neck trauma
Design
Study groups include dexmedetomedtomidine group and remifentanil group
Block randomization with random aloocation
The sample size is 80 people
Trial phase is 3
Settings and conduct
The present study is a randomized controlled clinical trial study on patients who referred to Al-Zahra Hospital due to neck trauma after approval of the plan. The neck was selected in Al-Zahra Hospital and Hospital of Isfahan and after making sure that the NPO was 8 hours, the patients were randomly divided into two groups R and D through Random Allocation software.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1- Age 60-18 years of both sexes
2- Candidate for neck surgery following neck trauma
3- ASA class 1 and 2
4- Conscious satisfaction
5- Malampati class 1 to 3
6- BMI less than 30
7- Do not use sedatives and opioids
8- Do not use beta blocker
Exclusion criteria
1- Inability to intubate the patient
2- Drug allergy during injection
3- Failure to complete the consent form
Intervention groups
In the dexmedetomtetomidine group, 2 cc of dexmedetomtetomidine equivalent to 200 μμ in a 50 cc syringe is mixed with 0.9% normal saline at a rate of 1 g / kgμ1 for 10 minutes as loading and then at a dose of 0.5 g / kg / hμ in maintenance Remifentanil group, 2 mg remifentanil mixed with 48 cc normal saline 0.9% and loaded with a loading dose of 0.75 g / kgμ75 for 10 minutes and then 0.1 g / kg / minμ is prescribed as maintenance.
Main outcome variables
Time required for intubation, heart rate, systolic blood pressure, diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220307054213N1
Registration date:2022-05-26, 1401/03/05
Registration timing:registered_while_recruiting
Last update:2022-05-26, 1401/03/05
Update count:0
Registration date
2022-05-26, 1401/03/05
Registrant information
Name
Sajad Opera
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 2419
Email address
sajad.op.2014@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-19, 1401/01/30
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of dexmedetomidine and remifentanil on the quality of endotracheal intubation with videolaryngoscope in patients with neck trauma
Public title
Comparative study of the effect of dexmedetomidine and remifentanil on the quality of endotracheal intubation with videolaryngoscope in patients with neck trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-60 years old from both genders
candidate for neck neck trauma surgery
ASA class 1 or 2
Informed consent
malmpathy class 1 to 3
BMI less than 30
non sedative or opioid user
non betablocker user
Exclusion criteria:
Inability to intubating the patient
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random blocks (blocks of 4) are divided into 2 groups of intervention and control. Randomization tool is random allocation. People are randomly divided into two groups, ie it is not known in advance which patient in which group Is utilizing random tool maker
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and health care providers and individuals in the role of data collection are blind to the study, ie the patient does not know which group he is in. The physician in charge of intubation also does not know what part the patient is anesthetized with.the collector of data is also blind to 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 Isafahan university of medical sciences
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.MUI.MED.REC.1400.833
Health conditions studied
1
Description of health condition studied
Intratracheal intubation with videolaryngoscope in patients with neck trauma
ICD-10 code
XIX
ICD-10 code description
Injury, poisoning and certain other consequences of external causes
Primary outcomes
1
Description
time needed to intubation
Timepoint
At the beginning of intervention
Method of measurement
Stopwatch
2
Description
number of successful intubation
Timepoint
at the beginning of intervention
Method of measurement
Counting
3
Description
systolic blood pressure
Timepoint
0,1,3,5,10,15 minutes after intervention
Method of measurement
manometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group anesthetized by dexmedetomidine2 cc of dexmedetomodetomidine equivalent to 200 μμ in a 50 cc syringe is mixed with 0.9% normal saline c48 and injected at a rate of 1 g / kgμ1 for 10 minutes as loading and then at a dose of 0.5 g / kg / hμ. Main brand Not intended.
Category
Treatment - Drugs
2
Description
Intervention group: group anesthetized by remifentanil.mg 2 mg remifentanil with 0.48% cc normal saline is administered at a loading dose of 0.75 μ / kgμ for 10 minutes and then 0.1 g / kg / minμ as maintenance.No brand is intended.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital Isfahan University of Medical Sciences
Full name of responsible person
دکتر مهرداد مسعودی فر
Street address
sofe
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
international@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mansour Siavash dastjerdi
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Fax
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Mehrdad Masoudifar
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3620 1992
Email
masoudifar@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Mehrdad Masoudifar
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31336201992
Email
masoudifar@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Mehrdad Masoudifar
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31336201992
Email
masoudifar@med.mui.ac.ir
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
Undecided - It is not yet known if there will be 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
Information about key variables can be shared after being unidentified
When the data will become available and for how long
after finishing the project
To whom data/document is available
All researchers in academic institutions
Under which criteria data/document could be used
For further review of the published article
From where data/document is obtainable
Send request to email masoudifar@med.mui.ac.ir
What processes are involved for a request to access data/document