Protocol summary

Summary
The aim of this double-blind clinical trial study was to evaluate the effect of intravenous infusion of Dexmedetomidin to control bleeding and postoperative pain in functional endoscopic sinus surgery in Matini, Kashan Hospital. Inclusion criteria included patients aged between 15 and 75 years of age, ASA class I, II, and HB>10grdlin patient whit Pansinusitis. Exclusion criteria included history of sensitivity to Dexmedetomidin, coagulation disorders, past surgical history at the same of location, uncontrolled high blood pressure. Samples were randomly divided into 3 groups of 32 individuals in intervention and control groups. Group A infusion Dexmedetomidin 0.2 μ/ Kg/h and Group B infusion Dexmedetomidin 0.5 μ /Kg/h, Group C infusion Normal saline with the volume equal to a dose of Dexmedetomidine. Induction was carried out by using 0.03 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. The bleeding rate was also examined and recorded based on the weight of gases and volume of the suction tank.In wake-up time from reverse injection until eyes opening, Patents were recovered from anesthesia whit using 0.06 mg/kg Neostigmine and 0.03 mg/kg Atropin .Main outcome measures: Bleeding volume, Systolic blood pressure, Diastolic blood pressure, O2 saturation, Heart rate, postoperative pain in recovery andin2, 6, 12, 24 hour after surgery in the ward.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082935987N1
Registration date: 2017-10-24, 1396/08/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-24, 1396/08/02
Registrant information
Name
Fahimeh Abam
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5533 4342
Email address
abam-f@mail.kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dexmedetomidine infusion in control bleeding and postoperative pain in functional endoscopic sinus surgery
Public title
Effect of dexmedetomidine infusion in control bleeding and postoperative pain in functional endoscopic sinus surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged between 15 and 75 years of age, ASA class I, II, and HB>10grdlin patient whit Pansinusitis. Exclusion criteria: history of sensitivity to Dexmedetomidine, coagulation disorders, past surgical history at the same of location, uncontrolled high blood pressure
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
N/A
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
Kashan University of Medical Sciences
Street address
Ghotbe Ravand Boulevard, Kashan
City
Kashan
Postal code
Approval date
2016-12-08, 1395/09/18
Ethics committee reference number
IR.KAUMS.REC.1395.102

Health conditions studied

1

Description of health condition studied
Chronic pansinusitis
ICD-10 code
J32.4
ICD-10 code description
Pansinusitis NOS

Primary outcomes

1

Description
Bleeding volume
Timepoint
During surgery
Method of measurement
The number of gas consumed and the amount of blood suctioned

2

Description
Mean arterial pressure
Timepoint
Every 15 minutes till the end of surgery
Method of measurement
In mmHg with intra arterial manometry

3

Description
heart rate
Timepoint
Every 15 minutes till the end of surgery
Method of measurement
With cardiac monitoring

4

Description
Pain severity
Timepoint
In recovery, after 2,6,12,24 hour in ward
Method of measurement
visual analog scale

Secondary outcomes

empty

Intervention groups

1

Description
Group1: Infusion Dexmedetomidin 0.2 μ/ Kg/h
Category
Prevention

2

Description
Group 2: Infusion Dexmedetomidin 0.5 μ /Kg/h
Category
Prevention

3

Description
Group 3: Iinfusion Normal saline with the volume equal to a dose of Dexmedetomidin
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Matini Hospital
Full name of responsible person
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
kashan
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, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Absm
Position
Assistant Anesthesiologist
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0026
Fax
Email
fahimehabam@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Fazel
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0026
Fax
Email
drmfazel@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Abam
Position
Assistant Anesthesiologist
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5533 4342
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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