Purpose: Comparison between Nitroglycerin and Labetalol on bleeding during nasal surgery. Design and criteria: This study is prospective, randomized and clinical trial. Seventy patients over 16 years were randomly in two groups. The first group received nitroglycerin, the nitroglycerin dose rate of 5 mcg / min every 3 to 5 minutes, then to the extent prescribed by 5 mcg / min was added. They received labetalol, the starting dose is 5 mg in labetalol group. And to establish anti-hypertension effect desired, can be 5 to 10 mg every 5 minutes once received. The surgeon and patients are blinded about the type of drug. Inclusion criteria: candidate for nasal surgery; American Society of Anesthesiology (ASA) I and II
Exclusion criteria: history of cardiovascular disease; previous hypertension; liver or kidney disease; hemoglobin below 10; coagulation disorders; receiving aspirin or medicines bleeding. Primary and secondary outcome: mean arterial blood pressure, volume of bleeding, heart rate, need for additional drug. Time of measurement: before induction, every 5 minutes to 75 minutes, after induction, during and end of surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014021712094N4
Registration date:2014-05-24, 1393/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-24, 1393/03/03
Registrant information
Name
Majid Razavi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 110 8630
Email address
razavim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Science
Expected recruitment start date
2013-12-06, 1392/09/15
Expected recruitment end date
2014-04-09, 1393/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Labetalol and Nitroglycerin in control of blood pressure and bleeding reduction in septorhinoplasty surgery
Public title
Comparison of Labetalol and Nitroglycerin in control of blood pressure and bleeding reduction in septorhinoplasty surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: candidate for nasal surgery; American Society of Anesthesiology (ASA) I and II
Exclusion criteria: history of cardiovascular disease; history of hypertension; liver or kidney disease and coagulation disorders; hemoglobin below 10 ; receiving aspirin or other anticoagulation's before surgery
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
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 Mashhad University of Medical Sciences
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2013-11-30, 1392/09/09
Ethics committee reference number
911214
Health conditions studied
1
Description of health condition studied
nasal surgery
ICD-10 code
Y60.0
ICD-10 code description
Unintentional cut, puncture, perforation or haemorrhage during surgical and medical care
Primary outcomes
1
Description
Mean arterial blood pressure
Timepoint
Before induction, Every 5 minutes to 75 minutes, after induction, during surgery and end of surgery
Method of measurement
Non-invasive monitoring of blood pressure
Secondary outcomes
1
Description
Volume of bleeding
Timepoint
Before induction, every 5 minutes to 75 minutes, after induction, during surgery and end of surgery
Method of measurement
Total gauze consumption and suction
2
Description
Heart rate
Timepoint
Before induction, every 5 minutes to 75 minutes, after induction, during surgery and end of surgery
Method of measurement
Hemodynamic monitoring
3
Description
Need for additional drug
Timepoint
Time of measurement: Before induction, every 5 minutes to 75 minutes, after induction, during surgery and end of surgery
Method of measurement
Based on the dose of drug
Intervention groups
1
Description
Intervention group 1 : they received nitroglycerin. The nitroglycerin dose rate of 5 mcg / min every 3 to 5 minutes, then to the extent prescribed by 5 mcg / min was added.
Category
Treatment - Drugs
2
Description
Intervention group 2 : they received labetalol, the starting dose is 5 mg in labetalol group. And to establish anti-hypertension effect desired, can be 5 to 10 mg every 5 minutes once received
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr Majid Razavi
Street address
Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
Razavim@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
Razavim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)