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The effect of fentanyl and sufentanil in combination with propofol on changes in heart rate and blood pressure after laryngoscopy and endotracheal intubation

Protocol summary

Study aim
Comparison of the effect of fentanyl and sufentanil in combination with propofol on changes in heart rate and blood pressure after laryngoscopy and endotracheal intubation
Design
A non-randomized double-blinding clinical trial with the control group with parallel groups
Settings and conduct
This non-randomized double-blind clinical trial is carried out at Feyz Hospital in Isfahan. In this study, 96 eligible patients will be admitted and randomly divided into 3 parallel groups. Then, for these three groups, induction of anesthesia was performed with "propofol alone", "fentanyl in combination with propofol" and "sufentanil in combination with propofol", respectively.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age range between 18-65 years, American Society of Anesthesiologists (ASA) classification equal to I or II, general anesthesia candidates require endotracheal intubation. Exclusion criteria include having kidney, liver, heart, or lung failure, addiction, having an airway abnormality, and being allergic to the drugs being studied.
Intervention groups
Intervention group 1: In this group for patients, induction of anesthesia with fentanyl 3 μg/kg at the time of induction of anesthesia with lidocaine 1.5 mg/kg, propofol 2 mg/kg with atracurium 0.6 mg/kg is performed. Intervention group 2: In this group for patients, induction of anesthesia with sufentanil 0.3 μg / kg during induction of anesthesia with lidocaine 1.5 mg/kg, propofol 2 mg/kg with atracurium 0.6 mg/kg is performed. Control group: In this group for patients, induction of anesthesia with normal saline at the time of induction of anesthesia with lidocaine 1.5 mg/kg, propofol 2 mg/kg with atracurium 0.6 mg/kg is performed.
Main outcome variables
Heart rate, Blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N18
Registration date: 2021-01-01, 1399/10/12
Registration timing: registered_while_recruiting

Last update: 2021-01-01, 1399/10/12
Update count: 0
Registration date
2021-01-01, 1399/10/12
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fentanyl and sufentanil in combination with propofol on changes in heart rate and blood pressure after laryngoscopy and endotracheal intubation
Public title
The effect of fentanyl and sufentanil in combination with propofol on changes in heart rate and blood pressure after laryngoscopy and endotracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 18-65 years, American Society of Anesthesiologists (ASA) classification equal to I or II General anesthesia candidates require endotracheal intubation
Exclusion criteria:
Having kidney, liver, heart, or lung failure Addiction Having an airway abnormality Being allergic to the drugs under study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the study, the drugs will be prepared by an anesthesiologist before the intervention. In terms of the amount of the drug, all drugs will be reached the same volume using distilled water. These syringes will be coded and placed in the operating room and delivered daily to the anesthesiologist, who will prescribe them without knowing the type of medication. Also, the patient, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
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
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-10-17, 1399/07/26
Ethics committee reference number
IR.MUI.MED.REC.1399.632

Health conditions studied

1

Description of health condition studied
Patients under general anesthesia require endotracheal intubation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Heart beat
Timepoint
Immediately before, 1, 3, 5 and 10 minutes after laryngoscopy
Method of measurement
Monitoring device

2

Description
Blood pressure
Timepoint
Immediately before, 1, 3, 5 and 10 minutes after laryngoscopy
Method of measurement
Monitoring device

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In this group for patients, induction of anesthesia with normal saline at the time of induction of anesthesia with lidocaine 1.5 mg/kg, propofol 2 mg/kg with atracurium 0.6 mg/kg is performed.
Category
Placebo

2

Description
Intervention group 1: In this group for patients, induction of anesthesia with fentanyl 3 μg/kg at the time of induction of anesthesia with lidocaine 1.5 mg/kg, propofol 2 mg/kg with atracurium 0.6 mg/kg is performed.
Category
Treatment - Drugs

3

Description
Intervention group 2: In this group for patients, induction of anesthesia with sufentanil 0.3 μg / kg during induction of anesthesia with lidocaine 1.5 mg/kg, propofol 2 mg/kg with atracurium 0.6 mg/kg is performed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Azim Honarmand
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
honarmand@med.mui.a.ir

2

Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Azim Honarmand
Street address
Anesthesiology Department, Kashani Hospital, Kashani Street.
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
honarmand@med.mui.a.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
honarmand@med.mui.a.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
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
honarmand@med.mui.a.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahdieh Kazemi
Position
Non-faculty medicine
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Mahdieh906@gmail.com

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
There is no further information
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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