Objectives: In this study the effects and complications of propofol and etomidate in patients with urological surgeries will be investigated.
Design: Randomized single blind
Setting and conduct:177 patients within 50 year's old or more who has minor urologic surgeries will be divided in 2 groups receiving propofol and Etomidate.
Major Inclusion and Exclusion criteria: Patients with ambulatory elective urological surgery with age more than 50 will be included and patients with history of adrenal insufficiency and history of allergy to the Etomidate or Propofol wil be excluded.
Intervention: Injection of Etomidate or Propofol
main outcome measures: pain relief and hemodynamic instability
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015082022734N1
Registration date:2015-10-15, 1394/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-15, 1394/07/23
Registrant information
Name
Mani Mofidi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2221
Email address
mofidi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparison of sedation and hemodynamic effects between propofol and etomidate in urological patients
Public title
comparison of sedation between propofol and etomidate in patients with elective urological surgery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
patients with ambulatory elective urological surgery; age more than 50; ASA class I , II
exclusion criteria:
history of adrenal insufficiency; history of vital sign instability; history of allergy to the Etomidate or Propofol
Age
From 50 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
177
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients divided to the 2 groups by table of random numbers .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Sciences
Street address
Ghods st, Keshavarz BLV
City
Tehran
Postal code
Approval date
2015-03-16, 1393/12/25
Ethics committee reference number
93/د/130/2368
Health conditions studied
1
Description of health condition studied
urological disease
ICD-10 code
N21.1
ICD-10 code description
Calculus in urethra
Primary outcomes
1
Description
sedative effects
Timepoint
every 5 minute until 30 minute
Method of measurement
questionaire
Secondary outcomes
1
Description
vital signs
Timepoint
every 5 minute until 30 minute
Method of measurement
questionaire
Intervention groups
1
Description
Etomidate will be injected intravenously by dose of 0.1 mg/kg, when inadequate response another 0.05 mg/kg will be injected
Category
Treatment - Drugs
2
Description
Propofol will be injected intravenously by dose of 1 mg/kg, when inadequate response another 0.5 mg/kg will be injected