Determination of the effect of two dose of sublingual Sufentanil on heart rate and blood pressure changes after laryngoscopy and endotracheal intubation
Design
Randomized controlled three blinded clinical trial on 96 patients undergoing intubation. Patients were randomly divided into three groups with simple randomization by Random Allocation Software
Settings and conduct
A clinical trial on 96 patients who will refer to the operating room center of Al-Zahra Hospital in Isfahan in the years 2020-2021. Patients, the physician who will collect the data, and the statistician who will analyze the data will not be informed about the patient's study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ASA I or ASA II; Patients aged 18 to 65 years; Patients who were candidates for elective surgery under general anesthesia requiring tracheal intubation.
Exclusion criteria: Patients with cardiac, hepatic and renal insufficiency; patients with drug addictions; patients with airway anomalies.
Intervention groups
First Intervention group receive sublingual Sufentanil 0.1 microgram per kilogram 3 minutes before anesthetic drug injection.
Second Intervention group receive sublingual Sufentanil 0.2 microgram per kilogram 3 minutes before anesthetic drug injection.
Control group receive sublingual normal saline before anesthetic drug injection.
Main outcome variables
Systolic, diastolic and mean blood pressure; arterial oxygen saturation; mean heart rate; ST-T changes in electrocardiogram
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090129001615N5
Registration date:2020-11-26, 1399/09/06
Registration timing:retrospective
Last update:2020-11-26, 1399/09/06
Update count:0
Registration date
2020-11-26, 1399/09/06
Registrant information
Name
Azim Honarmand
Name of organization / entity
Alzahra hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
honarmand@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-10, 1399/05/20
Expected recruitment end date
2020-10-11, 1399/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of two dose of subligual Sufentanil on heart rate and blood pressure changes after laryngoscopy and endotracheal intubation
Public title
Evaluation of sublingual sufentanil effect in laryngoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age: 18-65
Patients with grade 1 or 2 of American Society of Anesthesiologists (ASA) grading
patient needed endotracheal intubation in general anesthesia
Exclusion criteria:
Patients with heart failure disease
Patients with renal failure disease
Patients with hepatic failure disease
Patients with airway anomalies
Patients aged 18 to 65 years
Patients with addiction to drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by using SPSS software. We have 96 patients and we give them numbers from 1 to 96. Then we enter these numbers into the SPSS. This software divides the patients into three groups and each patient is assigned a specific random number. By these numbers each patient is in his own group. The unit of randomization is individualized.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The physician who will collect the patient’s data and the statistician who will analyze data have no information about the study group assignments. The study drugs will be injected by similar syringes in volume and color and they also will be administered for patients after induction of anesthesia so the patients will have no information about the injected drugs
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan university of medical science, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-08-22, 1399/06/01
Ethics committee reference number
IR.MUI.MED.REC.1399.421
Health conditions studied
1
Description of health condition studied
Patients who need generalize anesthesia with tracheal intubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Before intervation and 1, 3, 5 and 10 minutes after intervation
Method of measurement
Blood pressure manometer
2
Description
Diastolic blood pressure
Timepoint
Before intervation and 1, 3, 5 and 10 minutes after intervation
Method of measurement
Blood pressure manometer
3
Description
Heart rate
Timepoint
Before intervation and 1, 3, 5 and 10 minutes after intervation
Method of measurement
Heart monitoring
Secondary outcomes
1
Description
Arterial O2 saturation
Timepoint
Before intervation and 1, 3, 5 and 10 minutes after intervation
Method of measurement
Puls oximeter
2
Description
ST interval and T wave changes
Timepoint
Before intervation and 1, 3, 5 and 10 minutes after intervation
Method of measurement
Electrocardiogram
Intervention groups
1
Description
First intervention group receive sublingual Sufentanil 0.1 microgram per kilogram 3 minutes before anesthetic drug injection.
Category
Prevention
2
Description
Second Intervention group receive sublingual Sufentanil 0.2 microgram per kilogram 3 minutes before anesthetic drug injection.
Category
Prevention
3
Description
Control group receive sublingual normal saline before anesthetic drug injection.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Shokouh Sadeghizade Dehkordi
Street address
Alzahra hospital, Shohada sofe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
honarmand@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8008
Email
honarmand@med.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
Azim Honarman
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Science, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8008
Email
honarmand@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine Sciences, Isfahan University of Medical, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8008
Email
honarmand@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine Sciences, Isfahan University of Medical, Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8008
Email
honarmand@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Main outcome information
When the data will become available and for how long
Since Publication
To whom data/document is available
Researchers working in academic, scientific and industrial institutes
Under which criteria data/document could be used
En Statistical analysis
From where data/document is obtainable
Dr Azim Honarmand
What processes are involved for a request to access data/document
Send email and mention why you need documentation. One to two weeks after sending the request