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Comparison of propofol and dexmedetomidine in reducing blood pressure and bleeding during endoscopic sinus surgery

Protocol summary

Summary
Objectives: Endoscopic sinus surgery as the treatment of choice is widely used especially in patients with chronic sinusitis that does not respond to medical therapy. The aim of this study is to compare the effect of propofol with dexmedetomidine in reducing blood pressure and bleeding during endoscopic sinus surgery. Design: Block randomization, double blind, without placebo, trial phase 2, including 100 patients who are candidate for endoscopic sinus surgery. Setting and conduct: Fentanyl, 1 µg/kg, IV injection to induce anesthesia. Nesdonal, 5 mg/kg, IV injection to induce anesthesia. Atracurium, 0.5 mg/kg, IV injection for muscle relaxation. Participants including major eligibility criteria: All patients who are candidate for endoscopic sinus surgery. Intervention: Dexmedetomidine, 1 µg/kg as initial dose and 0.4 to 0.8 µg/kg/h IV infusion. Propofol, 50-150 µg/kg/min IV infusion. Main outcome measures: Bleeding volume, Systolic blood pressure, Diastolic blood pressure, O2 saturation, Heart rate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015101814056N5
Registration date: 2016-01-09, 1394/10/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-09, 1394/10/19
Registrant information
Name
Hesameddin Modir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 9680
Email address
he_modir@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of propofol and dexmedetomidine in reducing blood pressure and bleeding during endoscopic sinus surgery
Public title
Comparison of two medications in reducing blood pressure and bleeding in sinus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA class I–II; Age between 18-60 years old; Patients satisfaction; Not pregnant; No history of cardiovascular diseases (Arrhythmia, ischemia, and heart block); Not history of coagulopathies; Not taking opioids. Exclusion criteria: Sensitivity to the drugs used in this study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study the randomization was conducted using a random numbers table.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
IR.ARAKMU.REC.1394.228

Health conditions studied

1

Description of health condition studied
Chronic sinusitis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis

Primary outcomes

1

Description
Mean arterial pressure
Timepoint
Every 15 minutes to the end of surgery
Method of measurement
Sphygmometer

2

Description
Bleeding volume
Timepoint
During surgery
Method of measurement
The number of gas consumed and the amount of blood suctioned

Secondary outcomes

empty

Intervention groups

1

Description
Dexmedetomidine, 1 µg/kg as initial dose and 0.4 to 0.8 µg/kg/h IV infusion. Propofol, 50-150 µg/kg/min IV infusion.
Category
Prevention

2

Description
Propofol, 50-150 µg/kg/min IV infusion.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir kabir hospital
Full name of responsible person
Dr Hesameddin Modir
Street address
Amir kabir hospital. Parastar square. Rah-Ahan street. Arak. Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Ali Asghar Yaghoobi
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences, Vice Chancellor for Research
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
Arak University of Medical Sciences
Full name of responsible person
Dr Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3641
Fax
Email
He_modir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3641
Fax
Email
He_modir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3641
Fax
Email
He_modir@yahoo.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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