Protocol summary

Summary
The aim of this double-blind clinical trial study was to evaluate the intravenous infusion effect of dexmedetomidine to control bleeding during functional endoscopic sinus surgery in 2016 in Imam Khomeini Hospital, Ahwaz. Inclusion criteria included patients aged between 18 and 60 years of age, ASA class I, II and exclusion criteria included diabetes mellitus, coagulation disorders, kidney and liver dysfunction, cerebrovascular disease, cardiovascular disease, high blood pressure, asthma, COPD, psychiatric disease, drug allergy, taking beta-blockers, heart rate less than 55. Samples were randomly divided into two groups of 30 individuals in intervention and control groups. Induction was carried out by using 1 mg midazolam, 2 μ/kg fentanyl, 2mg/kg propofol, 0.5 mg/kg atracurium. For maintenance purposes, 50% N20-O2 was combined with 100µ/kg/min propofol, 0.2 µ/kg/min remifentanil. 1μ/kg dexmedetomidine was injected within 10 minutes in the intervention group then 0.5 μ/kg/hr of dexmedetomidine infusion began. Also, normal saline was used in the control group with the volume equal to a dose of dexmedetomidine. Then the blood pressure and heart rate were measured every 5 minutes up to the reversal of neuromasular blockade. The bleeding rate was also examined and recorded based on the weight of gases and volume of the suction tank, wake-up time from reverse injection until eyes opening, intraoperative drug consumption and the severity of nausea and vomiting within two hours of recovery. Dexmedetomidine as well as propofol and remifentanil infusion was discontinued respectively 15 and 5 minutes before the end of surgery. Patents were recovered from anesthesia using 0.05 mg/kg neostigmine and 0.02 mg/kg atropine.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012929256N2
Registration date: 2017-03-04, 1395/12/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-04, 1395/12/14
Registrant information
Name
Shahrzad Pooyan
Name of organization / entity
Ahvaz Jodishapur University
Country
Iran (Islamic Republic of)
Phone
+98 71 3822 1266
Email address
pooyan.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous infusion of dexmedetomidine in control bleeding during functional endoscopic sinus surgery
Public title
Effect of of dexmedetomidine in control bleeding during sinus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing endoscopic sinus surgery; aged between 16 and 60 years; ASA class I and II. Exclusion Criteria: diabetes mellitus; coagulation disorders; kidney and liver dysfunction; cerebrovascular disease; cardiovascular disease; high blood pressure; asthma; chronic obstructive pulmonary disease; psychiatric patients; drug allergy; taking beta-blockers; heart rate of less than 55.
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ahvaz Jundishapur University of Medical Sciences Ethics Committee
Street address
Ethics Committee, Vice-Chancellor for Research and Technology, Ahvaz University of Medical Sciences, Golestan street, Ahvaz
City
Ahvaz
Postal code
Approval date
2016-11-26, 1395/09/06
Ethics committee reference number
IR.AJUMS.REC.1395.558

Health conditions studied

1

Description of health condition studied
Haemorrhagic condition
ICD-10 code
D69.9
ICD-10 code description
Haemorrhagic condition, unspecified

Primary outcomes

1

Description
bleeding
Timepoint
q 15 minute up to the end of anesthesia
Method of measurement
data collected from standard operting room monitoring systems

Secondary outcomes

1

Description
nausea and vomit
Timepoint
every 30 minutes during 2 hours recovery time
Method of measurement
VAS score

2

Description
awakening time
Timepoint
after injection of neuromascular blockade
Method of measurement
time after reversal of neuromasculare blockade till eye opening on command

Intervention groups

1

Description
Intervention group: After induction of anesthesia 1µ/ kg/min Dexmedtomidin be injected within 10 minutes, then dexmedtomidin infusion begins with 0.5 µ /kg/minute.
Category
Treatment - Drugs

2

Description
Control group: After induction of anesthesia, 50 ml normal saline as placebo administrated.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini Hospital of Ahvaz
Full name of responsible person
Sharzad pouyan
Street address
lmam khomeini hospital of ahvaz, azadegan Street, Ahvaz, khozestan.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Makhmalzadeh
Street address
Ahvaz Jundishapur University of Medical Sciences, vice-chancellor for research and technology, Golestan street, Ahvaz, Khozestan
City
Ahvaz
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 and Technology of Ahvaz Jundishapur 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
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Sharzad Pooyan
Position
Anesthesia resident
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, medicine school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
Phone
+98 61 3571 5794
Fax
Email
sheripooya@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Sharzad Pooyan
Position
Anesthesia resident
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, medicine school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
Phone
+98 61 3571 5794
Fax
Email
sheripooya@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Sharzad Pooyan
Position
Anesthesia resident
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, medicine school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
Phone
00
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
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