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Comparison effect of intranasal Remifentanil with intranasal Dexmedetomidine on changes in heart rate and blood pressure after laryngoscopy and tracheal intubation.

Protocol summary

Study aim
Comparing the effect of intranasal remifentanil with intranasal dexmedetomidine on changes in heart rate and blood pressure after laryngoscopy and tracheal intubation.
Design
In this study, a phase 3 double-blind randomized controlled clinical trial with a control group of 186 laryngoscopy candidate patients in three equidistant groups divided into 1 μg/kg dexmedetomidine, 4 μg/kg remifentanil and the same volume of normal saline in 30 Minutes before, intranasal laryngoscopy was injected and heart rate and blood pressure changes were compared in three groups.
Settings and conduct
This study was conducted in the first half of 1403 in Al-Zahra Hospital, Isfahan. The patients who collect the data are not aware of the type of medicine received.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 65 years with physical condition 1 and 2 are candidates for general anesthesia with tracheal intubation, without airway malformation and without alergy to studied drugs, intubation in the first attempt and in less than 15 seconds and consent to participate in the project.
Intervention groups
30 minutes before the laryngoscopy, the first group received 1 μg/kg of intranasal dexmedetomidine, the second group received 4 μg/kg of intranasal remifentanil, and the third group received the same volume of normal saline intranasally.
Main outcome variables
Blood pressure, heart rate, percentage of blood oxygen saturation, tachycardia, bradycardia, hypertansion, hypotansion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130311012782N60
Registration date: 2024-03-15, 1402/12/25
Registration timing: prospective

Last update: 2024-03-15, 1402/12/25
Update count: 0
Registration date
2024-03-15, 1402/12/25
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of intranasal Remifentanil with intranasal Dexmedetomidine on changes in heart rate and blood pressure after laryngoscopy and tracheal intubation.
Public title
Comparing effect of intranasal Remifentanil with intranasal Dexmedetomidine on heart rate and blood pressure after tracheal intubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 65 years Requires general anesthesia (laryngoscopy and intubation). Agree to participate in the study Patients with ASA 1 and 2
Exclusion criteria:
Airway malformation Allergy to the studied drugs Prolongation of the laryngoscopy process for more than 15 seconds More than one attempt at intubation Dissatisfaction of patients and requests to withdraw from the study in any of the work steps.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 186
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are distributed in three groups by simple random method. 186 prepared white cards are written on 62 cards letter A, on 62 cards letter B and on 62 cards letter C and put into a container. When the patient enters the operating room, the patient is asked to take a card from the container. According to the letter written on the card, the patient is placed in one of three groups: remifentanil, dexmedetomidine, and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs used by the project manager are prepared in similar and coded syringes and are injected to the patients before laryngoscopy. The patients and the person collecting the information and the results of the intervention will be unaware of the type of drug injected.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in biomedical research of medical school of Isfahan University of Medical Sciences
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
IR.MUI.MED.REC.1402.415

Health conditions studied

1

Description of health condition studied
Intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation

Primary outcomes

1

Description
blood pressure
Timepoint
Before laryngoscopy and at 1, 3, 5 and 10 minutes after
Method of measurement
sphigmomanometer

2

Description
Heart bit
Timepoint
Before intubation and at 1, 3, 5 and 10 minutes after
Method of measurement
Pulse oximeter

3

Description
Blood oxygen saturation percentage
Timepoint
Before intubation and at 1, 3, 5 and 10 minutes after
Method of measurement
Pulse oximeter

Secondary outcomes

1

Description
Laryngoscopy time
Timepoint
During tracheal intubation
Method of measurement
Calculation of the time interval from the beginning to the end of tracheal intubation

2

Description
Amount of drugs received for hemodynamic stability of the patient
Timepoint
From the start of tracheal intubation to the time of exit from recovery
Method of measurement
Through registration in the patient file

Intervention groups

1

Description
Intervention group 1: Receiving 1 μg/kg intranasal Dexmedetomidine 30 minutes before intubation
Category
Prevention

2

Description
Intervention group 2: Receiving 4 μg/kg intranasal Remifentanil 30 minutes before intubation
Category
Prevention

3

Description
Control group: Receiving Normal Saline intranasally 30 minutes before intubation
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Elahe lotfi
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
lotfi.elahe1374@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 3070
Email
askari@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
Elahe Lotfi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
lotfi.elahe1374@gmail.com

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
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
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
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 9520
Email
al.mehrabi@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
The plan belongs to the government organization and it is not possible to share it
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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