The aim of this trial is to assess the effect of preoperative labetolol on the amount of bleeding during functional endoscopic sinus surgery(FESS). After signing written informed consent by parents, 32 patients, aged 20-60 years, with no contraindication for using study drugs, and scheduled for FESS, will be enrolled in this double- blind randomized controlled trial and randomly allocated into two groups. Patients with any positive history for coagulation disorders, cerebral/cardiac ischemia, liver,kidney,lung,heart disease or endocrinopathies or those who need to receive different anesthetic regimen will be excluded. The patients in the intervention group will receive labetolol infusion,1 mg/h after anesthesia induction. The anesthetic regimen is similar for both groups. Amount of bleeding and surgeon's satisfaction on surgical view will be recorded and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511295225N6
Registration date:2015-12-25, 1394/10/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-25, 1394/10/04
Registrant information
Name
Seyed mohammad Mireskandari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 8931
Email address
mireskandari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of labetolol on reducing bleeding during and after functional endoscopic sinus surgery(FESS) in patients scheduled for surgery
Public title
The effect of labetolol on reducing bleeding during and after functional endoscopic sinus surgery(FESS)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: informed consent of patients,age between 20 and 60 years old,ASA class I & II, no contraindication for using study drugs,scheduled for functional endoscopic sinus surgery (FESS) Exclusion criteria: need for a different anesthetic regimen, any positive history for coagulation disorders, cerebral/cardiac ischemia, liver,kidney,lung,heart disease or endocrinopathies
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex, Keashavrz Blvd, Tehran
City
Tehran
Postal code
Approval date
2015-11-10, 1394/08/19
Ethics committee reference number
IR.TUMS.REC.1394.1139
Health conditions studied
1
Description of health condition studied
Chronic sinusitis
ICD-10 code
J32
ICD-10 code description
Abscess empyema infection suppuration (chronic) of sinus (accessory)(nasal)
Primary outcomes
1
Description
Bleeding
Timepoint
Amount of bleeding during surgery
Method of measurement
Checking the amount of blood in suction container at the end of surgery
Secondary outcomes
empty
Intervention groups
1
Description
Infusion of Labetolol 1mg/h
Category
Prevention
2
Description
10ml Normal Saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Seyed Mohammad Mireskandari
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Science
Full name of responsible person
Dr. Masoud Yoonesian
Street address
Central department of Tehran University of Medical Sciences, Intersection of Keshavarz Blvd. and Qods St.
City
Tehran
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, Tehran University of Medical Science
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
Valiasr Hospital
Full name of responsible person
Dr Seyed Mohammad Mireskandari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2386
Fax
Email
mireskandari@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Valiasr Hospital
Full name of responsible person
Dr Seyed Mohammad Mireskandari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2386
Fax
Email
mireskandari@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Valiasr Hospital
Full name of responsible person
Dr Seyed Mohammad Mireskandari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2386
Fax
Email
mireskandari@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)