1): Objectives: In order to decreasing time of surgery and optimizing field of sinus endoscopic surgery we compare bisoprolol with clonidine. (2): Design: In a prospective double-blind randomized study thirty nine patients with Chronic or recurrent rhinosinusitis with or without nasal polyposis subjected to refractory to medical treatment were recruited in our center. (3) Setting and conduct: All the patients were sent to the anesthesia preoperative room with any of our premedication 60 minutes before the surgery. (4) Participants including major eligibility criteria: American Society of Anesthesiologist (ASA) classification less than II younger than18 years old. (5) Intervention: These patients were evaluated with bisoprolol or clonidine as premedication (6) Main outcome measures: a better surgical field volume of blood loss and hemodynamic parameters.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015091023968N1
Registration date:2015-10-12, 1394/07/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-12, 1394/07/20
Registrant information
Name
Rozita Jafari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 2109125187278
Email address
dr.rozitajafari57@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-12-31, 1391/10/11
Expected recruitment end date
2014-01-31, 1392/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of oral bisoprolol and clonidine on surgical field conditions during functional endoscopic sinus surgery
Public title
Comparative effects of oral bisoprolol and clonidine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion:
Chronic or recurrent rhinosinusitis with or without nasal polyposis" patients at least 18 years of age" Patients with American Society of Anesthesiologist (ASA) classification less than II"
Exclusion criteria:
Severe ischemic heart disease (IHD)" asthma" Coagulation or bleeding disorders
Age
From 28 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In order to select the patients in two group of control and treatment we used random sampling numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi, Yaman,Chamran Motorway,Tehran, Iran
City
Tehran
Postal code
1956944413
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
S.bmu7.REC.1394.133
Health conditions studied
1
Description of health condition studied
Nasal polyposis
ICD-10 code
J33.8
ICD-10 code description
پوليپ كوان نازوفارنكس
Primary outcomes
1
Description
surgical field situation
Timepoint
overall the surgery
Method of measurement
Fromme- Boezaart Scale
2
Description
Volume of bleeding
Timepoint
overall of surgical time
Method of measurement
after eliminating of serum volume used during surgery from volume of suction tank
Secondary outcomes
1
Description
Vital sign
Timepoint
every an hour during surgery
Method of measurement
Digital Blood Pressure Monitor
Intervention groups
1
Description
Control group : oral clonidine one hour before the endoscopic surgery for controlling the surgical field fom Tolid Daro factory
Category
Treatment - Drugs
2
Description
Intervention group:with 2.5 orally bisoprolol ratiopharm one hour before the endoscopic surgery for controlling the surgical field from Hazipatika factory Germany
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Hospital
Full name of responsible person
Rozita Jafari
Street address
Darabad, Niaavaran, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
دکتر رضا مسعودی
Street address
Arabi, Yaman,Chamran Motorway,Tehran, Iran.
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 of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rozita Jafari
Position
Fellowship in Rhinology
Other areas of specialty/work
Street address
Niaavaran Darabad
City
Tehran
Postal code
1956944413
Phone
+98 21 2610 5242
Fax
+98 21 2610 5242
Email
dr.rozitajafari57@yahoo.com
Web page address
pr.nritld@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rozita Jafari
Position
Fellowship in Rhinology
Other areas of specialty/work
Street address
Niavaran Darabad
City
Tehran
Postal code
1956944413
Phone
+98 21 2610 5242
Fax
+98 212126105242
Email
dr.rozitajafari57@yahoo.com
Web page address
sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences/Masih Hospital
Full name of responsible person
Rozita Jafari
Position
Fellowship in Rhinology
Other areas of specialty/work
Street address
Niaavaran Darabad
City
Tehran
Postal code
1956944413
Phone
+98 21271233100
Fax
+98 21 2610 5242
Email
dr.rozitajafari57@yahoo.com
Web page address
sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)