Comparison of the quality of awake intubation with fiber optics in patients receiving dexmedetomidine with midazolam and fentanyl in Rasoul-e-Akram Hospital in 2016-17
The quality of awake intubation with fiber optic is compared in patients receiving dexmedetomidine or midazolam and fentanyl in Rasoul-e-Akram Hospital in 1395-96.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized,
Settings and conduct
Patients undergoing elective surgery at Rasoul-e-Akram Hospital in Tehran in 1395-1959 were studied. Using the table of random numbers, patients are divided into two groups of D and F.
Group D are individuals who receive 1mcg / kg of dexmedetomidine infusion within 10 minutes and then receive 0.5 mcg / kg / h.
Group F are people who receive 2 mcg / kg fentanyl and 1 mg midazolam IV.
After reaching the peak of the effect of the drug, intubation with fiber opeptic by one third-year anesthesia assistant, not aware of the type of the prescribed drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range 20 to 60 years
ASA grade 1-2
Candidate for elective surgical operation in Rasoule-Akram hospital
Candidate for awake intubation
Exclusion criteria:
Pregnant women
Patients not able to collaborate (intellectual disability, low awareness, ...)
Patients with A-V block in ECG
Patients addicted to drugs of abuse or analgesics
History of allergic reaction to each of the drugs under study
Emergency operation
Heart failure
Uncontrolled asthma
Incidence of adverse effects during study (including laryngospasms, bronchospasm, Ramsey scale >4 , any kind of hemodynamic changes requiring pharmaceutical intervention)
Intervention groups
Group D receive infusions of 1mcg / kg of trimodimide dosage in 10 minutes and then continued at 0.5 mcg / kg / h.
Group F patients receive 2mcg / kg fentanyl and 1 mg midazolam IV.
Main outcome variables
Hemodynamic status; Spo2; FOB (fiber optics intubation) duration; frequency of attempts for FOB
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161220031487N9
Registration date:2018-04-27, 1397/02/07
Registration timing:retrospective
Last update:2018-04-27, 1397/02/07
Update count:0
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
مهرداد Mesbah kiaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 346 5866
Email address
dr.mmesbah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the quality of awake intubation with fiber optics in patients receiving dexmedetomidine with midazolam and fentanyl in Rasoul-e-Akram Hospital in 2016-17
Public title
Comparison of two treatments for improving the outcomes in awake intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20 to 60 years
ASA grade 1-2
Candidate for elective surgical operation in Rasoule-Akram hospital
Candidate for awake intubation
Exclusion criteria:
Pregnant women
Patients not able to collaborate (intellectual disability, low awareness, ...)
Patients with A-V block in ECG
Patients addicted to drugs of abuse or analgesics
History of allergic reaction to each of the drugs under study
Emergency operation
Heart failure
Uncontrolled asthma
Incidence of adverse effects during study (including laryngospasms, bronchospasm, Ramsey scale >4 , any kind of hemodynamic changes requiring pharmaceutical intervention)
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
52
More than 1 sample in each individual
Number of samples in each individual:
3
After entering the operation room and before the administration of the drug, at the time of the maximizing the effect of drug medication (15 minutes for the dexmedetomidine and 5 minutes for fentanyl and midazolam) and the third immediately after the intubation
Actual sample size reached:
52
More than 1 sample in each individual
Actual sample size in each individual:
3
Randomization (investigator's opinion)
Randomized
Randomization description
At first, explanations about the method of work, as well as the advantages and disadvantages of both groups, are given to the patient, and they will be informed that they will be allocated to one of the two groups randomly. After receiving the patients' informed consent, using a table of random numbers, patients are randomly allocated in one of the D and F groups. Due to the fact that the syringes will be in equal numbers (shots) in both groups and the syringes are not labeled, the patient will not be aware of the type of the drug being injected.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is unaware of the group in which he or she is allocated and the type of the medication he is receiving.
After maximizing the effect of medication, the intubation was performed with oral fiber optic by a third-year anesthesia resident, without knowing the prescription drug type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Between Sheykh Fazlollah highway and Chamran highway, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-08-25, 1396/06/03
Ethics committee reference number
IR.IUMS.FMD.REC1396.9311174006
Health conditions studied
1
Description of health condition studied
Failed or difficult intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
Heart rate
Timepoint
Before premedication, after premedication and after intubation
Method of measurement
Using patient monitoring system
2
Description
Blood pressure
Timepoint
Before premedication, after premedication and after intubation
Method of measurement
Using patient monitoring system
3
Description
Arterial blood gas analysis
Timepoint
Before premedication, after premedication and after intubation
Method of measurement
Arterial blood gas analysis system
4
Description
Analgesia
Timepoint
Before premedication, after premedication and after intubation
Method of measurement
Ramsey sedation scale
Secondary outcomes
1
Description
Attempts for awake intubation with fiber optic
Timepoint
During intubation
Method of measurement
Counting the number of attempts for intubation
Intervention groups
1
Description
Intervention group: infusions of 1mcg / kg of trimodimide dosage in 10 minutes and then continued at 0.5 mcg / kg / h
Category
Treatment - Drugs
2
Description
Control group: 2 mcg / kg fentanyl and 1 mg midazolam IV.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rassoul-e-Akram hospital
Full name of responsible person
Valiollah Hassani
Street address
Niyayesh St., Sattarkhan st.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
valiollah_hassani7958@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Between Sheykh Fazlollah and Chamran highway, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6651 5001
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Valiollah Hassani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Between Sheykh Fazlollah and Chamran highway, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 982166515001
Email
valiollah_hassani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Valiollah Hassani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Between Sheykh Fazlollah and Chamran highway, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6651 5001
Email
valiollah_hassani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Valiollah Hassani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Between Sheykh Fazlollah and Chamran highway, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6651 5001
Email
valiollah_hassani@yahoo.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
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
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