1. Home
  2. Approved trials
  3. » فارسی

Comparison of labetalol and dexmedetomidine on 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 labetalol 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 and propofol, 2.5 mg/kg IV administer to induce anesthesia. 0.5 mg/kg Atracurium IV infusion for muscle relaxation.Major inclusion criteria: ASA class I to II; Age between 18 to 60 years old; Patients satisfaction. Exclusion criteria: pregnancy; history of cardiovascular diseases (Arrhythmia, ischemia, and heart block); history of coagulopathies; taking opioids; History of sensitivity to the drugs used in this study. Intervention: Dexmedetomidine, 1 µg/kg as initial dose and 0.4 to 0.8 µg/kg/h IV infusion. labetalol 0.25 mg/kg as initial dose and1 to 2 mg/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: IRCT2016080914056N8
Registration date: 2016-09-15, 1395/06/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-15, 1395/06/25
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
2016-01-18, 1394/10/28
Expected recruitment end date
2017-01-17, 1395/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of labetalol and dexmedetomidine on reducing blood pressure and bleeding during endoscopic sinus surgery
Public title
Comparison of labetalol and dexmedetomidin on bleeding during endoscopic sinus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA class I and II; Age between 18 to 60 years old; Patients satisfaction. Exclusion criteria: pregnancy; history of cardiovascular diseases (Arrhythmia, ischemia, and heart block); history of coagulopathies; taking opioids; History of 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study the randomization was conducted with block randomization method

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
2016-01-18, 1394/10/28
Ethics committee reference number
IR.ARAKMU.REC.1394.288

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
Bleeding volume
Timepoint
End of surgery
Method of measurement
Suctioned blood volume

2

Description
Mean arterial pressure
Timepoint
Every 10 minutes till the end of surgery
Method of measurement
In mmHg with intra arterial manometry

3

Description
O2 saturation
Timepoint
Every 10 minutes till the end of surgery
Method of measurement
Pulse oxymeter

4

Description
heart rate
Timepoint
Every 10 minutes till the end of surgery
Method of measurement
With cardiac monitoring

Secondary outcomes

empty

Intervention groups

1

Description
Dexmedetomidine at dose of 1 µg/kg injected over 10 minutes then 0.4 to 0.8 µg/kg/h IV infused.
Category
Prevention

2

Description
Labetalol at dose of 0.25 mg/kg injected over 10 minutes then 1 to1 mg/min IV infused.
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 Mohammad Rafeie
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
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
Loading...