Comparison between the effect of Dexmedetomidine, Neostigmine, and Ketamine coadministered with bupivacaine 0.5% in epidural administration on decreasing of fibrosis after laminectomy
Comparison between effect of dexmedetomidine, neostigmine and ketamine coadministered with bupivacaine 0.5% in epidural administration on decreasing of fibrosis after laminectomy
Design
phase two clinical trial with parallel groups, double blinded, randomised on 81 patients.
for randomisation the rand function of excel software was used
Settings and conduct
epidural injection of each group drugs during the laminectomy surgery by the sergeon in valiasr hospital, arak ,iran.
all patients who participate in the trial, the sergeon, the data analysor and the trial responsible intern were blind.
Participants/Inclusion and exclusion criteria
inclusion criteria:
all patients candidate for laminectomy surgery
all patients with informed consent to participate in the trial
all patients with range of age between 25 to 70 years old
all patients with anesthetic ASA class I or II
exclusion criteria:
all patients out of range of age between 25 to 70 years old
all patients who were not candidate for laminectomy surgery
all patients with sensitivity to ketamin, neostigmine and dexmedetomidine
all patients with anesthetic ASA class more than II
all female patients in pregnancy or lactation period
all patients with uncontrolled psychological disorders
Intervention groups
dexmedetomidine group: epidural injection with bupivacaine 0.5%
ketamin group: epidural injection with bupivacaine 0.5%
neostigmine group : epidural injection with bupivacaine 0.5%
Main outcome variables
Mean pain score of patients
the mean value of thickness of fibrosis due to laminectomy in MRI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181212041947N1
Registration date:2020-08-24, 1399/06/03
Registration timing:registered_while_recruiting
Last update:2020-08-24, 1399/06/03
Update count:0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Zoha Khademi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3223 0788
Email address
z.khademi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of Dexmedetomidine, Neostigmine, and Ketamine coadministered with bupivacaine 0.5% in epidural administration on decreasing of fibrosis after laminectomy
Public title
effect of Dexmedetomidine, Neostigmin and Ketamin on fibrosis of laminectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients candidate for Laminectomy surgery
All patients with informed consent to participate in the trial
All patients with range of age between 25 to 70 years old
All patients with Anesthetic ASA class I or II
Exclusion criteria:
All patients out of range of age between 25 to 70 years old
All patients who were not candidate for Laminectomy surgery
All patients with Sensitivity to Dexmedetomidine, Neostigmin and Ketamin
All patients with ASA class more than II (III, IV)
All female patients in pregnancy or lactation period
All patients with uncontrolled psychological disorders
Age
From 25 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in 3 groups A and B and C.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2018-10-21, 1397/07/29
Ethics committee reference number
IR.ARAKMU.REC.1397.188
Health conditions studied
1
Description of health condition studied
Laminectomy surgery
ICD-10 code
M96.1
ICD-10 code description
Postlaminectomy syndrome, not elsewhere classified
Primary outcomes
1
Description
Mean value of thickness of fibrosis due to laminectomy
Timepoint
3 months after surgery
Method of measurement
Milimeters
2
Description
Pain
Timepoint
2, 6, 12 hours after surgery
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:We inject 0.3 milligram in kilogram of ketamine (volume of which is increased to 3 millilitre), is added to 75 mg of Marcaine 0.25 percent.
Category
Treatment - Drugs
2
Description
Intervention group2: We inject 2/5 milligram of Neostigmine (volume of which is increased to 3 millilitre), is added to 75 mg of Marcaine 0.25 percent.
Category
Treatment - Drugs
3
Description
Intervention group3: We inject 1 micro gram in kilogram of Dexmedetomidin (volume of which is increased to 3 millilitre), is added to 75 mg of Marcaine 0.25 percent.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
alikamaliir@yahoo.vom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ali Nazemi Rafie
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
z.khademi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak