Background: Propofol is a short acting intravenous hypnotic drug used for induction and maintenance of general anesthesia and sedative purposes. One of the complications of induction of anesthesia by propofol is a substantial decrease in arterial blood pressure and heart rate which can be intensified by adding remifentanil, an ultra-short acting potent narcotic. In this study, two different doses of prophylactic ephedrine for coping with hemodynamic changes due to induction of anesthesia with propofol and remifentanil will be investigated.
Materials and Methods: This study is a randomized clinical trial with a double-blind placebo-controlled design. 150 patients (ASA I and II) candidate for short-term minor elective surgery under general anesthesia are studied. Patients will be randomized to three groups: normal saline, ephedrine (0.07 mg/kg) and ephedrine (0.15 mg/kg). Anesthesia will be induced in all groups with propofol (2.5 mg/kg) and remifentanil (3 µg/kg). No neuromuscular blocking agent is used. The patients with history of hypertension, angina pectoris, heart failure, thyrotoxicosis, gastrointestinal reflux, and cerebrovascular disease, history of using anti-hypertensive or cardiac related drugs and hypersensitivity to eggs or soya bean will be excluded from the study. The patients' hemodynamic status would be assessed in 4 steps: immediately before, 2 minutes after induction of anesthesia, and 1 and 5 minutes after intubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112061566N3
Registration date:2012-01-31, 1390/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-31, 1390/11/11
Registrant information
Name
Farid Zand
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4270
Email address
zandf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive effect of ephedrine to counteract hemodynamic changes following induction of anesthesia with propofol and remifentanil
Public title
Effect of ephedrine to counteract hemodynamic changes following induction of anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Exclusion criteria: 1) history of hypertension, angina pectoris, heart failure, thyrotoxicosis, gastrointestinal reflux, and cerebrovascular disease, 2) Use of muscle relaxants during operation, 3)history of using anti-hypertensive or cardiac related drugs, 4) hypersensitivity to eggs, 5) hypersensitivity to soya bean, 6) patient's dissatisfaction at any time.
Inclusion criteria:1)age range of 20-50 years, 2)ASA I & II, 3)weight of 60-80 kg, 4) candidate for short-term operations under general anesthesia.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
143
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
Shiraz University of Medical Sciences Ethics Committee
Street address
Zand Blvd.
City
Shiraz
Postal code
Approval date
2011-03-05, 1389/12/14
Ethics committee reference number
CT-84-2050
Health conditions studied
1
Description of health condition studied
hypotension and heart rate fluctuation resulting from anesthesia induction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hypotension resulting from anesthesia induction
Timepoint
Before intervention, 2 minutes after anesthesia induction, 1 and 5 minutes after tracheal intubation
Method of measurement
Operating room monitor
2
Description
Heart rate fluctuation resulting from anesthesia induction
Timepoint
Before intervention, 2 minutes after anesthesia induction, 1 and 5 minutes after tracheal intubation
Method of measurement
Operating room monitor
Secondary outcomes
1
Description
Cardiac arythmia resulting from anesthesia induction
Timepoint
Continuous monitoring from the patients' interance to the operating room until five minutes after tracheal intubation
Method of measurement
Operating room monitor
Intervention groups
1
Description
Case group 1: Besides normal anesthesia induction drugs, ephedrine 0.07mg/kg was infused by a 2cc syringe
Category
Prevention
2
Description
Case group 2: Besides normal anesthesia induction drugs, ephedrine 0.15mg/kg was infused by a 2cc syringe
Category
Prevention
3
Description
Control group: Besides normal anesthesia induction drugs, distilled water was infused by a 2cc syringe as placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Street address
Zand st, Central building of the University
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ali Hosseinipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Zand St, Shahid Faghihi Hospital
City
Shiraz
Postal code
Phone
+98 71 1832 3519
Fax
Email
hoseinipur@sums.ac.ir; alihoseinpour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farid Zand
Position
Anesthesiologist, Associate professor
Other areas of specialty/work
Street address
Zand St, Shahid Faghihi Hospital
City
Shiraz
Postal code
Phone
+98 71 1233 7636
Fax
Email
zandf@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Hosseinipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
City
Shiraz
Postal code
7185734587
Phone
+98 71 1832 3519
Fax
Email
alihoseinipour@gmail.com,hoseinipur@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)