Comparing the effects of Propofol and Propofol-Ketamine anesthesia maintenance regime on hemodynamic parameters during anesthesia and postoperative complications in patients undergoing leg fracture surgery
(1)Objectives: Comparison of the effects of two anesthesia maintenance regime on hemodynamic parameters during anesthesia and postoperative complications in patients with leg fracture.(2)Design: The study was performed as randomized double-blind clinical trial on 94-95 on 60 patients who candidate for surgery and trial phase was 3. (3)setting and conduct:Patients were randomly divided to Propofol or Propofol – Ketamine group.All patients were anesthetized with 2mg/kg Propofol, 5μg/kg Fentanyl, and 0.5 mg/kg Atracurium after which one group of patients received Propofol (100 μg/kg/min) and the other group received a combination of Propofol Ketamine(50µg/kg/min Propofol and 25µg/kg/min Ketamine).(4)participants including major eligibility criteria:Patients who were candidate for leg fracture surgery with class 1 and 2 ASA and aged 15 to 45 years old entered the study.Patients who had addiction and had a history of motion disease were excluded.(5)interventtion: use of 2mg/kg Propofol, 5μg/kg Fentanyl, and 0.5 mg/kg Atracurium in both group for induction and use of Propofol 100 μg/kg/min in one group and of Propofol Ketamine combination (50µg/kg/min Propofol and 25µg/kg/min Ketamine) in another group for maintenance regime .
(6)main outcome measures: Heart rate, systolic and diastolic blood pressure, and MAP recorded when the patient is lying on the bed before induction, one minute after induction,after laryngoscopy and intubation and then in 10-minute intervals to the end of the procedure.Pain, nausea and vomiting after the patients were conscious up to 6 hours after the patient is sent out of recovery in 2-hour intervals using VAS criterion measured and analysised.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062222867N1
Registration date:2016-09-10, 1395/06/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-10, 1395/06/20
Registrant information
Name
Bibi Fatemeh Shakhs Emampour
Name of organization / entity
Birjand University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3244 3001
Email address
fatemeh.emampour@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology affairs of Birjand University of Medical Sciences (BUMS)
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Propofol and Propofol-Ketamine anesthesia maintenance regime on hemodynamic parameters during anesthesia and postoperative complications in patients undergoing leg fracture surgery
Public title
Comparing the effects of two anesthesia maintenance regime on hemodynamic parameters during anesthesia and postoperative complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients between 15-45 years old; Class 1 and 2 ASA; Candidate for leg fracture surgery.
Exclusion criteria:History of recent upper respiratory tract infection; Asthma; Allergy (to Propofol-Ketamine, eggs, and soya);Taking antipsychotic drugs; Neuromuscular diseases ; Epilepsy; Acid reflux; Hiatal hernia; Severe anemia; Severe liver diseases; Severe heart diseases; Severe lung diseases; Drugs addiction; A history of motion disease; Migraine
Age
From 15 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghafari St
City
Birjand
Postal code
Approval date
2014-11-30, 1393/09/09
Ethics committee reference number
IR.BUMS.1393.903
Health conditions studied
1
Description of health condition studied
Leg fracture
ICD-10 code
S82.8
ICD-10 code description
Fractures of other parts of lower leg
Primary outcomes
1
Description
Heart Rate
Timepoint
Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery
Method of measurement
Heart monitoring
2
Description
Systolic blood pressure
Timepoint
Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery
Method of measurement
Heart monitoring
3
Description
Diastolic blood pressure
Timepoint
Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery
Method of measurement
Heart monitoring
4
Description
Mean arterial pressure
Timepoint
Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery
Method of measurement
Heart monitoring
Secondary outcomes
1
Description
pain
Timepoint
After anesthesia is finished up to 6 hours after going out of recovery in 2-hour intervals
Method of measurement
Visual Analogue Scale (VAS)
2
Description
nausea
Timepoint
After anesthesia is finished up to 6 hours after going out of recovery in 2-hour intervals
Method of measurement
Visual Analogue Scale (VAS)
3
Description
vomiting
Timepoint
After anesthesia is finished up to 6 hours after going out of recovery in 2-hour intervals
Method of measurement
Visual Analogue Scale (VAS)
Intervention groups
1
Description
First group: Induction 2mg/kg of Propofol, 5μg/kg of Fentanyl, and 0.5 μg/kg of Atracurium and maintenance regime 100 μg/kg/min Propofol
Category
Treatment - Drugs
2
Description
Second group:Induction 2mg/kg of Propofol, 5μg/kg of Fentanyl, and 0.5 μg/kg of Atracurium and maintenance regime 50 μg/kg/min of Propofol + 25 μg/kg/min Ketamine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand Imam Reza Hospital
Full name of responsible person
Dr. Bibi Fatemeh Shakhs Emampour
Street address
Orthopedic operating room, Imam Reza Hospital
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Sharifzadeh
Street address
Birjand University of Medical Sciences, Ghafari St
City
Birjand
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, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Bibi Fatemeh Shakhs Emampour
Position
Anesthesiologist, Assistant professor of Birjand University of Medical Sciences
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari st
City
Birjand
Postal code
Phone
+98 56 3244 3001
Fax
+98 56 3244 5402
Email
f.emempour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Bibi Fatemeh Shakhs Emampour
Position
Anesthesiologist, Assistant professor of Birjand University of Medical Sciences
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari st
City
Birjand
Postal code
Phone
+98 56 3244 3001
Fax
+98 56 3244 5402
Email
f.emampour.gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Bibi Fatemeh Shakhs Emampour
Position
Anesthesiologist, Assistant professor of Birjand University of Medical Sciences
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari st
City
Birjand
Postal code
Phone
+98 56 3244 3001
Fax
+98 56 3244 5402
Email
f.emampour.gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)