Comparison of the effect of two drug combinations: Etomidate-Sufentanil with Ketamine-Sufentanil-Midazolam on changes in heart rate and blood pressure after laryngoscopy and endotracheal intubation
To determine and compare the effects of two different combinations Etomidate-Sufentanil with Ketamine-Sufentanil-Midazolam on heart rate and blood pressure changes after laryngoscopy and endotracheal intubation
Design
Three arm clinical trial with study control group, parallel group trial of 96 patients with blinded outcome assessment. Randomisation was centralised and computerised with randomized 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 aged 18 to 65 years, Patients with ASA I or ASA II, Patients who are 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 group receive Etomidate 0.3 milligram per kilogram plus Sufentanil 0.1 microgram per kilogram, Atracurium and Lidocaine.
Second group receive Ketamine 0.5 milligram per kilogram plus Sufentanil 0.1 microgram per kilogram plus Midazolam 0.07 milligram per kilogram, Atracurium and Lidocaine.
Third group which is the control group receive Etomidate 0.3 milligram per kilogram, Atracurium, Lidocaine and also normal saline.
Main outcome variables
Systolic blood pressure; Diastolic blood pressure; 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:IRCT20090129001615N4
Registration date:2020-10-28, 1399/08/07
Registration timing:registered_while_recruiting
Last update:2020-10-28, 1399/08/07
Update count:0
Registration date
2020-10-28, 1399/08/07
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
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two drug combinations: Etomidate-Sufentanil with Ketamine-Sufentanil-Midazolam on changes in heart rate and blood pressure after laryngoscopy and endotracheal intubation
Public title
Comparison of the effect of two drug combinations: Etomidate-Sufentanil with Ketamine-Sufentanil-Midazolam during laryngoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA (American Society of Anesthesiologists) grade:1 or 2
Patients aged 18 to 65 years
Patients who need tracheal intubation and general anesthesia
Exclusion criteria:
Patients with heart failure disease
Patients who are addicted to drugs
Patients with airway anomalies
Patients with hepatic failure disease
Patients with renal failure disease
Patients with over 65 years or under 18 years
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
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using Random Allocation software version 2.0. Ninety-six patients will be divided into 8 blocks of 12 members. For example, the first block will be included 12 patients that will be ordered non sequentially. The unit of randomization will be individualized. For allocation concealment, the physician administering the study drugs will not be informed from sequence of group assignment.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding will be performed as such: The physician who will collect the patient’s data and the statistician who will analyze data, have no information from 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
Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-08-31, 1399/06/10
Ethics committee reference number
IR.MUI.MED.REC.1399.438
Health conditions studied
1
Description of health condition studied
patients who need general anesthesia with tracheal intubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Systolic blood pressure mean in each group
Timepoint
Before intervention and 1, 3, 5 and 10 minutes after laryngoscopy
Method of measurement
Blood pressure manometer
2
Description
Diastolic blood pressure mean in each group
Timepoint
Before intervention and 1, 3, 5 and 10 minutes after laryngoscopy
Method of measurement
Blood pressure manometer
3
Description
Heart rate mean in each group
Timepoint
Before intervention and 1, 3, 5 and 10 minutes after laryngoscopy
Method of measurement
Heart monitoring device
Secondary outcomes
1
Description
Arterial oxygen saturation mean in each group
Timepoint
Before intervention and 1, 3, 5 and 10 minutes after laryngoscopy
Method of measurement
Pulse oximeter
2
Description
Electrocardiogram ST-T changes relative frequency in each group
Timepoint
Before intervention and 1, 3, 5 and 10 minutes after laryngoscopy
Method of measurement
Electrocardiogram
Intervention groups
1
Description
Intervention group 1: Patients will receive Etomidate (10 cc ampoules, 2 milligrams per cc, made by Abu Reihan Pharmaceutical Company) in the amount of 0.3 milligrams per kilogram body weight and Sufentanil (5 microgram ampoules per milliliter, made by the service institute Razavi drug) in the amount of 0.1 micrograms per kilogram of body weight. Both drugs will be injected intravenously and at the beginning of induction of anesthesia.
Category
Prevention
2
Description
Intervention group 2: Patients will receive Ketamine (50 milligrams per milliliter ampoule, made by Razavi Pharmaceutical Services Institute) in the amount of 0.5 milligrams per kilogram body weight, Sufentanil in the amount of 0.1 micrograms per kilogram body weight and Midazolam (5 milligrams per milliliter ampoule, made by Razavi Pharmaceutical Services Institute) in the amount of 0.07 milligrams per kilogram body weight. Both drugs will be injected intravenously and at the beginning of induction of anesthesia.
Category
Prevention
3
Description
Control group: Patients will receive Etomidate in the amount of 0.3 milligrams per kilogram body weight as well as normal saline (manufactured by Samen Pharmaceutical Company) as a placebo. Both will be injected intravenously and at the beginning of induction anesthesia.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al zahra hospital
Full name of responsible person
Kimia Karimian
Street address
Al Zahra hospital, Shohadayeh Sofeh 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
Hezarjerib 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 Honarmand
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical, School of Medicine Sciences, Hezar Jerib 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)
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
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
There is no collected data yet. After collecting patients' information and making patient’s identities unrecognizable, all the information will be published in an article.
When the data will become available and for how long
Since the publication of the article
To whom data/document is available
Researchers working in academic, scientific and industrial institutes
Under which criteria data/document could be used
Data publication will be done for additional statistical analysis after verifying the validity of the research center or the researcher who has requested the data.
From where data/document is obtainable
Dr Azim Honarmand
honarmand@med.mui.ac.ir
What processes are involved for a request to access data/document
The request for data will be answered 1 to 2 weeks after receiving email from the research center or the researcher.