The propose of this study is assess to competitive effect of Sevoflurane versus propofol on hemodynamic changes and complications after laminectomy during the year 2015. The statistical population included patients candied of laminectomy and sample size is 75. Inclusion criteria: age 20-70, same surgeon and anesthesia. The exclusion criteria included: systemic disease. In a randomized double blind clinical trial, the patients assigned 3 group: Sevoflurane, propofol and Sevoflurane Pulse propofol. The parameters of pain, hemodinamic change, shivering, nausea and vomiting, drug consumption and recovery duration was assessed with checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071122870N2
Registration date:2015-07-27, 1394/05/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-27, 1394/05/05
Registrant information
Name
Ali Khani
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3220 3150
Email address
khani-a@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Ilam University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Sevoflurane and Propofol on complications after laminectomy
Public title
The compartion effect of Sevoflurane versus Propofol on hemodynamic changes and complications after laminectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate for laminectomy; age 20-70; same surgeon and anesthesia.
Exclusion criteria: systemic disease
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples using the seal envelop technique and double blind, both for patients and researchers are collected.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ilam University of Medical Sciences
Street address
Pajohesh Blvd, Banganjab, Ilam
City
Ilam
Postal code
Approval date
2015-06-15, 1394/03/25
Ethics committee reference number
EC/94/H/280
Health conditions studied
1
Description of health condition studied
laminectomy
ICD-10 code
M99
ICD-10 code description
vertebral column
Primary outcomes
1
Description
pain
Timepoint
1,4,8,12,24 h after intervention
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Bleeding
Timepoint
During intervenation in surgery time
Method of measurement
pad
3
Description
Nausea & Vomiting
Timepoint
After intervention in recovery
Method of measurement
checklist and VAS
4
Description
Blood pressure
Timepoint
During intervenation in surgery time
Method of measurement
sphygmomanometer
5
Description
Hart rate
Timepoint
During intervenation in surgery time
Method of measurement
Pulse oximeter
Secondary outcomes
1
Description
drug consumption
Timepoint
during 24 h after surgery
Method of measurement
Mg
2
Description
The first movement time
Timepoint
after intervention during discharge
Method of measurement
hrs
3
Description
duration of recovery room
Timepoint
After intervention
Method of measurement
hrs
4
Description
urinary retention
Timepoint
After intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1: in propofol group 2-3 Mg/Kg propofol , o2 50%, N2o 50% was given.
Category
Treatment - Drugs
2
Description
Intervention group 2: in sevoflurane group 2-3 % Sevoflurane, o2 50%, N2o 50% was given
Category
Treatment - Drugs
3
Description
Intervention group 3: in sevoflurane plus propofol group 2-3 % Sevoflurane and 2-3 Mg/Kg propofol was given.