Comparison of the effects of two different doses intranasal Dexmedetomidine on heart rate and blood pressure changes after Laryngoscopy and Endotracheal intubation in patients need of anesthesia before surgery
Comparison of the effects of two different doses intranasal Dexmedetomidine on heart rate and blood pressure changes after Laryngoscopy and Endotracheal intubation in patients need of anesthesia before surgery
Design
This study was conducted in parallel, double-blind, randomized,90 patients who were in the Phase 3 trial were designed.
Settings and conduct
This study was a double-blind clinical trial that was performed on 90 patients undergoing surgery that referred to Al-Zahra hospital. Patients in this study were randomly divided into three groups of 30 patients.Patients in the first group received intranasal dexmedetomidine at a dose of 1μg/kg , and the second group received intranasal dexmedetomidine at a dose of 2μg/kg and control group received normal saline in the form of intranasal .
Participants/Inclusion and exclusion criteria
inclusion criteria: 1)Patients candidate Laryngoscopy and Endotracheal intubation 2)Patients older than 18 yeras old and younger than 65 years old
3)Patients with American society of anesthesiology physical status class 1,2 (ASAI,II) ؛ Exclusion criteria: 1)Head and neck masses 2)Airway malformation 3)Uncontrollable blood pressure(More than 180/110) 4)History of cardiovascular disease 5)History of respiratory disease 6)allergies to the drugs studied 7)Body Mass Index greater than 30
Intervention groups
Initially , informed consent is obtained from the patients. After placing the patients on the operating bed, inclusion of standard monitoring including pulsoximetr , capnograph, electrocardiograph (ECG) and the vital signs are attached.Then intervention group A receives 1μg/kg of intranasal dexmedetomidine and intervention group B receives 2 μg/kg of intranasal dexmedetomidine and control group receives normal saline ,30 minutes before induction of anesthesia inside both nostrils .
Main outcome variables
Blood pressure and heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N15
Registration date:2019-07-24, 1398/05/02
Registration timing:retrospective
Last update:2019-07-24, 1398/05/02
Update count:0
Registration date
2019-07-24, 1398/05/02
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of two different doses intranasal Dexmedetomidine on heart rate and blood pressure changes after Laryngoscopy and Endotracheal intubation in patients need of anesthesia before surgery
Public title
The effects of two different doses dexmedetomidine after Endotracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate Laryngoscopy and Endotracheal intubation
Patients older than 18 yeras old and younger than 65 years old
Patients with American society of anesthesiology physical status class 1,2 (ASAI,II)
Exclusion criteria:
Head and neck masses
Airway malformation
Uncontrollable blood pressure(More than 180/110)
History of cardiovascular disease
History of respiratory disease
allergies to the drugs studied
Body Mass Index greater than 30(BMI>30)
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to three groups A, B, C using the Random Allocation computer
software
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and placebo are prepared in one form and in the form of a volume in the syringe by the researcher, and the
hemodynamic changes are monitored and recorded, so the attending and the clinical caregiver and the evaluator and data analyser do not understand the type of medication and the investigator deciphers the codes after data analysis.
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
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-28, 1396/03/07
Ethics committee reference number
IR.MUI.REC.1396.3.794
Health conditions studied
1
Description of health condition studied
Blood pressure
ICD-10 code
R03.0
ICD-10 code description
Elevated blood-pressure reading, without diagnosis of hypertension
2
Description of health condition studied
Heart rate
ICD-10 code
R00.0
ICD-10 code description
Tachycardia, unspecified
Primary outcomes
1
Description
Heart rate changes
Timepoint
Before the intervention, 1 ,3, 5, 10 minutes after laryngoscopy
Method of measurement
Heart monitoring
2
Description
Systolic blood pressure
Timepoint
Before the intervention, 1 ,3, 5, 10 minutes after laryngoscopy
Method of measurement
Non invasive blood pressure monitor
3
Description
Diastolic blood pressure
Timepoint
Before the intervention, 1 ,3, 5, 10 minutes after laryngoscopy
Method of measurement
Non invasive blood pressure monitor
4
Description
Mean arterial pressure
Timepoint
Before the intervention, 1 ,3, 5, 10 minutes after laryngoscopy
Method of measurement
Non invasive blood pressure monitor
5
Description
Oxygen saturation
Timepoint
Before the intervention, 1 ,3, 5, 10 minutes after laryngoscopy
Method of measurement
Percent with pulse oximeter
6
Description
Recovery time
Timepoint
From the end of surgery to full consciousness
Method of measurement
Minute with using a chornometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A:Initially , informed consent is obtained from the patients. After placing the patients on the operating bed, inclusion of standard monitoring including pulsoximetr , capnograph, electrocardiograph (ECG) and the vital signs are attached . In group A, 1μg∙kg-1 of intranasal dexmedetomidine is given 30 minutes before induction of anesthesia inside both nostrils. Median arterial blood pressure, heart rate, systolic blood pressure and diastolic blood pressure at one, three, five and Ten minutes after intubation are recorded .
Category
Treatment - Drugs
2
Description
Intervention group B:Initially , informed consent is obtained from the patients. After placing the patients on the operating bed, inclusion of standard monitoring including pulsoximetr , capnograph, electrocardiograph (ECG) and the vital signs are attached . In group B, 2μg∙kg-1 of intranasal dexmedetomidine is given 30 minutes before induction of anesthesia inside both nostrils. Median arterial blood pressure, heart rate, systolic blood pressure and diastolic blood pressure at one, three, five and Ten minutes after intubation are recorded .
Category
Treatment - Drugs
3
Description
Control group: Initially , informed consent is obtained from the patients. After placing the patients on the operating bed, inclusion of standard monitoring including pulsoximetr , capnograph, electrocardiograph (ECG) and the vital signs are attached . In group C, normal saline is given 30 minutes before induction of anesthesia inside both nostrils. Median arterial blood pressure, heart rate, systolic blood pressure and diastolic blood pressure at one, three, five and Ten minutes after intubation are recorded .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulevard, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghyegh Haghjoo
Street address
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Amir Mohammad Ataie
Position
Medical Student/ Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hasht Behesht Building, Amin Alley, Bagh-e-Goldaste Street
City
Isfahan
Province
Isfehan
Postal code
8145845197
Phone
+98 31 3222 8461
Email
amir.ataie17@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Mohammad Ataie
Position
Medical Student/ Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hasht Behesht Building, Amin Alley, Bagh-e-Goldaste Street
City
Isfahan
Province
Isfehan
Postal code
8145845197
Phone
+98 31 3222 8461
Email
amir.ataie17@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available