Comparison of blood pressure control in two general anesthetics technique of isoflurane and propofol in two anti hypertensive nitroglycerine-Labetalol or remifentanil in functional sinus endoscopic surgery
Aims: Comparison of blood pressure control in two general anesthetics technique of isoflurane and propofol in two anti hypertensive nitroglycerine-Labetalol or remifentanil in functional sinus endoscopic surgery. Design: random, one-sided, single-centered, stage two clinical trials. How to do: Patients undergoing functional autonomic sinus endoscopy, which are indicative of controlled hypotension, are administered in both groups by anesthetics of inhaled isoflurane and venous propofol. Patients in each group are divided into two groups of patients, each with hyperthyroidism with either remifentanil or nitroglycerine-Labetalol. The main criteria for inclusion the study include patients undergoing functional sinus endoscopy, which should have a systolic blood pressure of more than 100 and a mean arterial pressure above 55. Main exclusion criteria include: patients with a history of blood pressure; antihypertensive drugs; addicted patients; use of nerve drugs; patients with coagulation disorder and anticoagulants. Interventions: Patients undergoing functional functional sinus endoscopy, which are indicative of hypotension, are administered to both groups of patients with inhaled anesthetics of isoflurane and venipuncture of propofol. Patients in each group are divided into two groups of patients, each with hyperthyroidism with either remifentanil or nitroglycerine-Labetalol. Main outcome variables: Blood pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102715108N3
Registration date:2017-11-19, 1396/08/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Reza Safaeian
Name of organization / entity
Iran University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4464 0531
Email address
rezasafaa@hotmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of blood pressure control in two general anesthetics technique of isoflurane and propofol in two anti hypertensive nitroglycerine-Labetalol or remifentanil in functional sinus endoscopic surgery
Public title
Blood pressure control in both intravenous and inhalation anesthetics in sinus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing functional sinus endoscopic surgery that should have a systolic blood pressure of more than 100 and an arterial hypertension above 55. Exclusion criteria: Patients with history of hypertension; antihypertensive drugs; addicted patients; use of neurological drugs; patients with coagulation disorder and anticoagulants.
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients are selected using randomized block method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2016-09-05, 1395/06/15
Ethics committee reference number
IR.IUMS.REC 1395.9311174004
Health conditions studied
1
Description of health condition studied
Blood pressure
ICD-10 code
R03.0
ICD-10 code description
Elevated blood-pressure reading, without diagnosis of hypertension
Primary outcomes
1
Description
Amount of blood pressure
Timepoint
At the entrance to the operating room, after the induction, 15, 30, 45, 60, 75, 90, and 105 minutes during surgery
Method of measurement
In mmHg using a mercury barometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients undergoing inhaled anesthetic of isoflurane and receive nitroglycerine-Labetalol.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients undergoing inhaled anesthetic of isoflurane and receive remifentanil.
Category
Treatment - Drugs
3
Description
Intervention group 3: Patients undergoing vein anesthetic of propofol and receive nitroglycerine-Labetalol.
Category
Treatment - Drugs
4
Description
Intervention group 4: Patients undergoing vein anesthetic of propofol and receive remifentanil.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr Reza Safaeian
Street address
Rasoul Akram Hospital, Satar Khan
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakouti
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr Reza Safaeian
Position
MD Medical Anesthesiology / Associate Professor
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 4464 0531
Fax
Email
rezasafa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Reza Safaeian
Position
MD Medical Anesthesiology / Associate Professor
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 4464 0531
Fax
Email
rezasafa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Majid Behrouzinia
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 4464 0531
Fax
Email
Dr_m_behroozinia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)