This is a randomized double–blind clinical trial (in terms of the patients, surgeon and researcher) which investigates the efficacy of Dexmedetomidine on the surgical bleeding and field in 72 patients who undergo endoscopic sinus surgery at Amiralmoemenin Hospital_Rasht. After explaining the process of the trial, written informed consent obtained from participants, they will be divided into two groups as random fixed block (36 patients in each group). Patients are excluded with use of anticoagulants; history of Acute and chronic renal failure; Diabetes; stroke; Coronary artery disease; hypertension; Deep vein thrombosis; Pulmonary embolism; peripheral vascular diseases; pregnancy. First group will receive Dexmedetomidine 1 /mg/kg in 10 mL of saline 0.9% dilution during the 10 minutes before induction of anaesthesia and then infusion continues at a dose of 0.2 to 1/mg/kg/hr and the second group receive only anaesthesia similar to the first group without infusion of Dexmedetomidine. For all patients anesthetic protocol are the same. The collected information will include: volume of bleeding during surgery on the scale Boezaart and systolic and diastolic blood pressure and Mean Arterial Pressure and heart rate in the time intervals between 15, 30, 60 and 90 minutes, and the surgeon satisfaction based on Likert scale (1-very bad to 5- very good), surgical time and complications of Dexmedetomidine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606211138N23
Registration date:2016-08-13, 1395/05/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-13, 1395/05/23
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Science, Vice Chancellor for Research
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Dexmedetomidine infusion on the bleeding and quality of surgical field in patients who undergo endoscopic sinus surgery
Public title
Efficacy of Dexmedetomidine infusion on the
bleeding in endoscopic sinus surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged between 16-60 years who undergo endoscopic sinus surgery; those with hemoglobin more than 10 mg/dL; normal clotting time and bleeding time; normal PT; PTT; INR; no history of airways problems and systemic disease or Mental disorders; no history of the anesthetic drugs sensitivity or any other medication and no history of bleeding disorders (such as hemophilia) ;Exclusion criteria: Use of anticoagulants such as heparin 48 hours before surgery; history of acute and chronic renal failure; diabetes; stroke; coronary artery disease; hypertension; deep vein thrombosis; pulmonary embolism; peripheral vascular diseases; pregnancy.
Age
From 16 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Science
Street address
Vice-Chancellor for Research Building, Opposite of Sepah Bank,Shahid Beheshti Blvd, Rasht
City
Rasht
Postal code
Approval date
2016-06-14, 1395/03/25
Ethics committee reference number
IR.GUMS.REC.1395.75
Health conditions studied
1
Description of health condition studied
Chronic sinusitis
ICD-10 code
J32.9
ICD-10 code description
Chronic sinusitis
Primary outcomes
1
Description
The amount of bleeding during surgery
Timepoint
in time intervals between 15; 30; 60 and 90 minutes
Method of measurement
scale Boezaart
Secondary outcomes
1
Description
systolic and diastolic blood pressure and Mean Arterial Pressure
Timepoint
in time intervals between 15; 30; 60 and 90 minutes
Method of measurement
Mercury manometers
2
Description
heart rate
Timepoint
in time intervals between 15; 30; 60 and 90 minutes
Method of measurement
Electrocardiogram
3
Description
surgeon satisfaction
Timepoint
in time intervals between 15; 30; 60 and 90 minutes
Method of measurement
Likert scale
4
Description
Duration of surgery
Timepoint
in time intervals between 15; 30; 60 and 90 minutes
Method of measurement
clock
Intervention groups
1
Description
First group: Dexmedetomidine 1/mg /kg in 10 mL of saline 9/0% during the 10 minutes before induction of anesthesia and then infusion continues at a dose of 0.2 to 1/mg/kg/hr.
Category
Prevention
2
Description
second group: receive only anesthesia similar to the first group without infusion of Dexmedetomidine.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Sudabeh Haddadi
Street address
Amiralmomenin Hospital, 17 Shahrivar St
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Science, Vice Chancellor for Research
Full name of responsible person
Susan Komaee
Street address
Vice-Chancellor for Research Building, Opposite of Sepah Bank,Shahid Beheshti Blvd, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Science, 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
Guilan University of Medical Sciences
Full name of responsible person
Dr Soudabeh Haddadi
Position
Professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital, 17 Shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
So_haddadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Soudabeh Haddadi
Position
Professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital, 17 Shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
So_haddadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)