Comparison of Hemodynamic Changes and Side Effects Due to Two Methods of General Anesthesia and Epidural Anesthesia in Patients Undergo Lumbar Laminectomy Surgery
Objectives:
In the present study, we compare the usage of two methods for anesthesia (general anesthesia and epidural anesthesia) to find the method with less hemodynamic changes and side effects due to anesthesia in patients undergo lumbar laminectomy.
Design:
In this clinical trial 60 patients who are candidate for lumbar laminectomy surgery will be randomly divided into two groups (group 1 and 2).
Setting and conduct:
The patients in group 1 will receive Midazolam and Fentanyl intravinously for anesthesia induction, then will be intubated using direct intratracheal method. Patients in group 2 will receive epidural injection of Lidocain for spinal anesthesia.
Major Inclusion and Exclusion Criteria:
Patients who are candidate for lumbar laminectomy who are categorized in ASA class 1 in NPO condition, without underline diseases or presence of epidural anesthesia contraindications.
Intervention:
Usage of two methods of general anesthesia or epidural anesthesia.
Main Outcome Measures (variables):
Finally, mean heart rate, blood pressure, presence of nausea and vomiting and postoperative pain will be compared with each other in patients of the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030419037N7
Registration date:2015-03-15, 1393/12/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-15, 1393/12/24
Registrant information
Name
Mahdieh Yousef-Zanjani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6004
Email address
yusefi.mahdieh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Hemodynamic Changes and Side Effects Due to Two Methods of General Anesthesia and Epidural Anesthesia in Patients Undergo Lumbar Laminectomy Surgery
Public title
Comparison of the Effects of Two Methods of General Anesthesia and Epidural Anesthesia During Lumbar Laminectomy Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 30 to 60 years of age who are candidate for lumbar laminectomy surgery and are categorized in ASA class 1 (The American Society of Anesthesiologists Physical Status classification system): Normal healthy patients with no organic, physiologic, or psychiatric disturbance.
Exclusion criteria:
Patients who use anti-hypertensive, analgesic or sedative agents; patients who are not NPO (nil per os); no patient's tendency for epidural anesthesia; obesity; presence of epidural anesthesia contraindications.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In this study, eligible patients will be entered randomly into the trial groups by usage of colored carts.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid-Bahonar Boulevard
City
Qazvin
Postal code
Approval date
2014-06-12, 1393/03/22
Ethics committee reference number
28.20.8852
Health conditions studied
1
Description of health condition studied
Heart rate instability due to anesthesia
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Blood pressure instability due to anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean heart rate
Timepoint
From the beginning of anesthesia every 5 minutes until 1 hour after surgery
Method of measurement
Monitor device
2
Description
Mean blood pressure
Timepoint
From the beginning of anesthesia every 5 minutes until 1 hour after surgery
Method of measurement
Monitor device
Secondary outcomes
1
Description
Post operation pain
Timepoint
From the beginning of surgery every 2 hours until 6 hours after the surgery
Method of measurement
Visual Analogue Scale questionnaire (VAS)
2
Description
Nasea and vomitting
Timepoint
During recovery time
Method of measurement
Objective
Intervention groups
1
Description
First intervention group:
Intravinously injection of Midazolam (Ampoule 5 mg/ml from Aburaihan drug manufacturing company, Iran) (0.1 to 0.3 mg/kg) and Fentanyl (Ampoule 50 from Pharmaceutical drug manufacturing company, Belgium) (1/5 μg/kg) for anesthesia induction and then direct intrathraceal intubation.
Category
Treatment - Other
2
Description
Second intervention group:
Epidural injection of Lidocain (Ampoule 20 mg/ml from Aburaihan drug manufacturing company, Iran) (2-3 ml) for spinal anesthesia using 25 Gauge Quincke spinal needle in L3-L4 or L4-L5 epidural spaces.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid-Rajayi Hospital
Full name of responsible person
Dr. Arezou Aghaali
Street address
Padegan Boulevard
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Arezou Aghaali
Street address
Shahid-Bahonar Boulevard
City
Qazvin
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Hosseyni Valami
Position
Anesthesiologist, Professor
Other areas of specialty/work
Street address
Shahid-Bahonar Boulevard
City
Qazvin
Postal code
Phone
+98 28 3333 6004
Fax
Email
yusefi.mahdieh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Arezou Aghaali
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Shahid-Bahonar Boulevard
City
Qazvin
Postal code
Phone
+98 28 3333 6004
Fax
Email
yusefi.mahdieh@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)