Studying the bolus dose of Dexmedetomidine effect in attenuating hemodynamic stress response to laryngoscopy and tracheal intubation in hypertensive patients
Assessment of bolus dose of Dexmedetomidine effect in attenuating hemodynamic stress response to laryngoscopy and tracheal intubation in hypertensive patients
Design
A randomized double-blinded clinical trial on 70 patients with or without hypertension as study and control groups. Randomization using Random allocation software allocated to 35 patient groups.
Settings and conduct
The research will be carried out in Urmia Emam Khomeini Hospital, affiliated to Urmia University of Medical Sciences. Dexmedetomidine at 4 microgram per kilogram of body weight concentration prepared in 50 cc syringes will be infused during 10 minutes for the study group and the control group will receive a normal saline infusion. Drug and placebo are indistinguishable. Anesthesia will be induced using 1% propofol until the losing eyelid reflex and Atracurium will be injected at 4mg/Kg dose. After 3 minutes of mask ventilation, the patient will be intubated and hemodynamic changes including heart rate, MAP, DBP, and SBP will be recorded at T0(basic hemodynamics), T1(5 minutes after drug injection)T2(after induction of anesthesia), T3( 1 minute after induction), T4( 3 minutes after intubation), T5(5 minutes after intubation) and T6( 10 minutes after intubation).
Participants/Inclusion and exclusion criteria
Inclusion criteria:Normotensive patients, stage I-II hypertensive patients at age 40-70
Exclusion criteria: patients under age 40 and above 70, stage III hypertension, patient refusal
Intervention groups
The study group patients will get a bolus IV infusion of dexmedetomidine before general anesthesia induction and the control group patients will get normal saline.
Main outcome variables
Systolic, diastolic, mean arterial blood pressure, and heart rate.
General information
Reason for update
Acronym
SBP,DBP,MAP,HR
IRCT registration information
IRCT registration number:IRCT20151219025600N5
Registration date:2024-07-24, 1403/05/03
Registration timing:prospective
Last update:2024-07-24, 1403/05/03
Update count:0
Registration date
2024-07-24, 1403/05/03
Registrant information
Name
Shahram Shokohi
Name of organization / entity
Urmia University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 8967
Email address
shokohi.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-31, 1403/05/10
Expected recruitment end date
2025-01-29, 1403/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the bolus dose of Dexmedetomidine effect in attenuating hemodynamic stress response to laryngoscopy and tracheal intubation in hypertensive patients
Public title
Bolus dose of dexmedetomidine effect on hemodynamic response to laryngoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
normotensive Patients
Stage I-II hypertensive patients
patients at age 40-70
Exclusion criteria:
Difficult intubation
BMI more than 30
Patient receiving Clonidine
Pregnancy
Laryngoscopy more than 20 seconds
Emergency surgery
Patients with heart blocks
ASA class III and more
Patients with pheochromocytoma
Patients with thyroid disorders
Patients with neuropathy
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The patients by block randomization will be allocated to equal groups of study and placebo using "random allocation" software providing computerized numbers. The numbers will be written on envelopes containing the drug or placebo notes and will be delivered to the anesthesia nurse as sealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the researcher who evaluates the outcomes will not informed of patients allocation to the study and control groups. Both drug and placebo will be colorless prepared and injected in 50 cc syringes at equal volumes. Each patient will allocate a number using randomization allocation software in sealed envelopes containing the drug or placebo delivered to the anesthesia nurse. The researcher will not be informed of syringe content.
Placebo
Used
Assignment
Other
Other design features
no more explanation
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Urmia Univerity of Medical Scineces-Imam Khomeini University Hospital
At time zero(basic hemodynamics),T1(5 minutes after drug or placebo injection),T2(after induction of general anesthesia) T3(one minute after tracheal intubation),T4(3 minutes after intubation) T5(5 minutes after intubation) T6( 10 minutes after intubation)
Method of measurement
Measuring using electronic cardiovascular monitoring device
2
Description
Diastolic blood pressure
Timepoint
At time zero(basic hemodynamics),T1(5 minutes after drug or placebo injection),T2(after induction of general anesthesia) T3(one minute after tracheal intubation),T4(3 minutes after intubation) T5(5 minutes after intubation) T6( 10 minutes after intubation)
Method of measurement
Measuring using electronic cardiovascular monitoring device
3
Description
Mean arterial pressure
Timepoint
At time zero(basic hemodynamics),T1(5 minutes after drug or placebo injection),T2(after induction of general anesthesia) T3(one minute after tracheal intubation),T4(3 minutes after intubation) T5(5 minutes after intubation) T6( 10 minutes after intubation)
Method of measurement
Measuring using electronic cardiovascular monitoring device
4
Description
Heart rate
Timepoint
At time zero(basic hemodynamics),T1(5 minutes after drug or placebo injection),T2(after induction of general anesthesia) T3(one minute after tracheal intubation),T4(3 minutes after intubation) T5(5 minutes after intubation) T6( 10 minutes after intubation)
Method of measurement
Measuring using electronic cardiovascular monitoring device
Secondary outcomes
1
Description
Hypnotic drug(propofol) induction dose in patients with hypertensive disease
Timepoint
At the end of anesthesia induction
Method of measurement
Propofol dose needed for induction of anesthesia as milligram
Intervention groups
1
Description
Intervention group:Patients without or with hypertension class I-II at age 40-70
Category
Treatment - Drugs
2
Description
Control group: Patients without or with hypertension class I-II at age 40-70 receiving placebo (normal saline infusion)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini University hospital of Urmia
Full name of responsible person
Shahram Shokohi
Street address
Ershad street, Modarres Boulvard
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Fax
+98 44 3345 7277
Email
emam-urm@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizade
Street address
Emergency street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Fax
+98 44 3193 7224
Email
research@umsu.ac.ir
Grant name
Non-use of financial grants
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Shahram Shokohi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ersahd street, Modarres boulvard, Imam Khomeini University hospital