Protocol summary

Summary
(1) Objectives: The propose of this study is assess the competitive effect of general anesthesia verses spinal on outcome after laminectomy (2) Design: The statistical population included patients under laminectomy and sample size was 50. In a randomized blind clinical trial with seal envelop method, the patients will be assigned 2 group: general or spinal anesthesia. This study is phase 2. (3) Setting and conduct: Patients after general anesthesia or spinal under laminectomy. (4) Participants: Inclusion criteria included: age 18-65 year , same surgeon and anesthesia. The exclusion criteria included: lack of patient agreement for spinal anesthesia, systemic disease, reaction of spinal anesthesia drug. (5) Intervention: in general anesthesia group with isofloran, o2 50%, N2 o 50% in maintenance of anesthesia and in spinal group with bupivacaine 5% intrathecally at L3 - L4 or L4 - L5 space in the sitting position were included in the study.(6) main outcome measures: pain, hemodinamic change, shivering, nausea and vomiting , drug consumption, surgeon and patients satisfaction, length of stay and the first movement time will be assessed with checklist.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015062222870N1
Registration date: 2015-09-21, 1394/06/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-21, 1394/06/30
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
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of general anesthesia and spinal on laminectomy
Public title
The comparation effect of general anesthesia verses spinal on outcome of laminectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-65 year; same surgeon and anesthesia. Exclusion criteria: lack of patient agreement for spinal anesthesia; systemic disease; reaction of spinal anesthesia drug.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
with seal envelop method, the patients assigned 2 group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of 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
IR.MEDILAM.EC/94/H/279-18/3/1394

Health conditions studied

1

Description of health condition studied
laminectomy
ICD-10 code
M99
ICD-10 code description
vertebral column

Primary outcomes

1

Description
shivering
Timepoint
After intervention in recovery
Method of measurement
checklist and VAS

2

Description
Bleeding
Timepoint
During intervention in surgery time
Method of measurement
Pad

3

Description
Pain
Timepoint
After intervention during 1,4,8,12,24 h after surgery
Method of measurement
Visual Analogue Scale (VAS)

4

Description
Nausea & Vomiting
Timepoint
After intervention in recovery
Method of measurement
Checklist

5

Description
Blood pressure
Timepoint
During intervenation under surgery
Method of measurement
sphygmomanometer

6

Description
Hart rate
Timepoint
During intervenation under surgery
Method of measurement
Pulse oximeter

Secondary outcomes

1

Description
cost
Timepoint
After intervention during discharge
Method of measurement
checklist

2

Description
drug consumption
Timepoint
during 24 h after intervenation
Method of measurement
according to Mg

3

Description
surgeon satisfaction
Timepoint
After intervention
Method of measurement
Questionnaire

4

Description
patients satisfaction
Timepoint
After intervention
Method of measurement
Questionnaire

5

Description
The first movement time
Timepoint
After intervention
Method of measurement
according to time duration after surgery

6

Description
Length of hospital stay
Timepoint
After intervention
Method of measurement
according to time duration of stay

7

Description
duration of recovery room
Timepoint
After intervention
Method of measurement
according to time duration

Intervention groups

1

Description
Intervention group 2: In spinal group patients using bupivacaine 5% , 15 mg intrathecally at L3 - L4 or L4 - L5 space in the sitting position were included in the study . bupivacaine manufacturer, is Aboureyhan
Category
Treatment - Drugs

2

Description
Intervention group 1: In general anesthesia group using propofol (2-3 Mg/Kg), 50% O2, 50% N2o, fentanyl, isoflurane and atracurium patients was undergoing surgery. propofol,fentanyl and isoflurane manufacturer, is Aboureyhan
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ali Khani
Street address
Shahid Beheshti Bolvar, Imam Khomeini Hospital, Ilam
City
Ilam

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ilam University of Medical Sciences
Full name of responsible person
Dr Koroosh Soleimannejad
Street address
Pajohesh Bolvd, Banganjab, Ilam
City
Ilam
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, Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Ali Khani
Position
MSc of Nursing
Other areas of specialty/work
Street address
Shahid Beheshti Blvd, Imam Khomeieni Hospital, Ilam
City
Ilam
Postal code
6931434978
Phone
+98 84 3333 7259
Fax
Email
nimakhani@gmail.com; khani-a@medilam.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical sciences
Full name of responsible person
Ali Khani
Position
MSc of Nursing
Other areas of specialty/work
Street address
Shahid Beheshti Blvd, Imam Khomeini Hospital,Ilam
City
Ilam
Postal code
6931434978
Phone
+98 84 3333 7259
Fax
Email
nimakhani@gmail.com; khani-a@medilam.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Ali Khani
Position
MSc of Nursing
Other areas of specialty/work
Street address
Shahid Beheshti Blvd, Imam Khomeini Hospital, Ilam
City
Ilam
Postal code
Phone
+98 84 3333 7259
Fax
+98 84 3333 7259
Email
nimakhani@gmail.com; khani-a@medilam.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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