Protocol summary

Summary
The aim of this study is to compare the effect of midazolam and dexmedetomidine on hemodynamic response control after laryngoscopy and intubation during upper extremity surgery. The study is carried out as a one-center double blind randomized clinical trial on 80 patients in ASA class І and II, being at the age of 18 to 60 years old and candidate for upper extremity elective surgery in Rajai hospital, Qazvin. Patients who are drug abusers or have cardiac and pulmonary diseases and hypertension will be excluded. Randomization will be done through block randomization method. For intervention group, 2 µg/kg fentanyl and 0.6 mg/kg dexmedetomidine and for control group 2 µg/kg fentanyl and 0.05 mg/kg midazolam will be injected as a prodrug. After two minutes, anesthesia induction will be performed using 2 mg/kg propofol and 0.2 mg/kg Atracurium. Three minutes after injection of atracurium, tracheal intubation will be performed through direct laryngoscopy. Systolic and diastolic blood pressure, mean arterial pressure, heart rate and arterial oxygen saturation will be measured at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of surgery and at recovery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017040833291N1
Registration date: 2017-05-04, 1396/02/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-05-04, 1396/02/14
Registrant information
Name
Ali Alizadeh
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 0105
Email address
a.alizadeh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dexmedetomidine and midazolam to control hemodynamic responses during laryngoscopy and intubation in upper extremity elective surgery
Public title
Comparison of dexmedetomidine and midazolam in hemodynamic response control during tracheal intubation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients at the age of 18 to 60 years old; class 1 and 2 of America Society of Anesthesiology (ASA); candidate for upper extremity elective surgery; willingness to participate in the study. Exclusion criteria: Difficult intubation; extreme obesity; Cardiac and pulmonary diseases; hypertension; Chronic Diseases; Allergic Diseases; opium addiction; pregnancy; body temperature over 38 degrees Celsius; history of using alpha-2 receptor antagonists; drugs using for high blood pressure (hypertension); Beta blockers; Acute Angle Closure Glaucoma; Lower respiratory tract problems and asthma; hypersensitivity to antihistamine.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will be assigned to intervention and control through block randomization method.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd, Qazvin
City
Qazvin
Postal code
3419759811
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
IR.QUMS.REC.1395.146

Health conditions studied

1

Description of health condition studied
Tracheal intubation
ICD-10 code
Y84.8
ICD-10 code description
Other medical procedures

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room
Method of measurement
Monitoring devise

2

Description
Diastolic blood pressure
Timepoint
at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room
Method of measurement
Monitoring devise

3

Description
Mean arterial blood pressure
Timepoint
at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room
Method of measurement
Monitoring devise

4

Description
Heart rate
Timepoint
at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room
Method of measurement
Pulse Oxymetery

5

Description
Arterial oxygen saturation
Timepoint
at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room
Method of measurement
Monitoring devise

Secondary outcomes

1

Description
Shivering
Timepoint
Every 10 min until 30 min after entering the recovery room
Method of measurement
Clinical observation

Intervention groups

1

Description
Intervention group: before induction, 2 µg/kg fentanyl and 0.6 mg/kg dexmedetomidine will be injected as a prodrug.
Category
Other

2

Description
Control group: before induction, 2 µg/kg fentanyl and 0.05 mg/kg midazolam will be injected as a prodrug.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaee educational and treatment center
Full name of responsible person
Dr. Ali Alizadeh
Street address
Rajee Hospital, Padegan Avenu, Qazvin.
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Shahid Bahonar Blvd, Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Bijan Heyrat
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Rajee Hospital, Padegan Avenu, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3332 0105
Fax
Email
dr.bijan.heyrat@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Dr. Ali Alizadeh
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Rajee Hospital, Padegan Avenu, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3332 0105
Fax
Email
Ali.alizadeh935@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Ali Alizadeh
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Rajee Hospital, Padegan Avenu, Qazvin
City
Qazvin
Postal code
Phone
00
Fax
Email
Ali.alizadeh935@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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