Comparison of the Effect of Ketamine Infusion with Dexmedetomidine Infusion during Postoperative Fusion of Lumbar Vertigo in Acute Post-Operative Pain.
Comparison of the Effect of Ketamine Infusion with Dexmedetomidine Infusion during Postoperative Fusion of Lumbar Vertigo in Acute Post-Operative Pain.
Design
Clinical trials with control group, with parallel groups, blind, randomized
Settings and conduct
The study population consisted of patients who underwent PSF surgery in Rasoul Hospital in year 97. This study was a double-blind randomized clinical trial on 87 patients undergoing PSF surgery At Hazrat-e-Rasool Hospital, Tehran, have been admitted.
The placement of the three groups at the start of the study will be randomized; the selected patients will be divided into three groups: ketamine, dexmedmotidine and control group.
Participants/Inclusion and exclusion criteria
Entry criteria includes candidates for performing PSF surgery with ASA1 or ASA2, and exclusion criteria including a history of psychiatric illness, systemic diseases such as heart failure, liver, kidney, lung, infectious disorder, abnormalities and addicted patients.
Intervention groups
Bradycardia is considered to be a moderate arterial pressure of more than 20% by a decrease of more than 20% of the heart rate per minute (relative to the heart rate constant) and hypotension. If bradycardia is present, atropine will be administered at a dose of 0.01 mg / kg and, Infused ephedrine 0.1mg / kg is used intravenously.
Main outcome variables
Satisfaction rate of analgesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180723040570N2
Registration date:2019-08-14, 1398/05/23
Registration timing:registered_while_recruiting
Last update:2019-08-14, 1398/05/23
Update count:0
Registration date
2019-08-14, 1398/05/23
Registrant information
Name
Nasim Nikoubakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 9854
Email address
nikoobakht.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-05, 1398/05/14
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Ketamine Infusion with Dexmedetomidine Infusion during Postoperative Fusion of Lumbar Vertigo in Acute Post-Operative Pain.
Public title
Comparison of the Effect of Ketamine Infusion with Dexmedetomidine Infusion during Postoperative Fusion of Lumbar Vertigo in Acute Post-Operative Pain.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Entry criteria included candidates for PSF surgery and ASA1 or ASA2
Exclusion criteria:
history of the disease Psychiatry
systemic diseases such as heart failure, liver, kidney, lung
infectious disorder
conciousness abnormalities
addicted patients
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
87
Randomization (investigator's opinion)
Randomized
Randomization description
At first, an anesthetist examines patients and then evaluates patients on entry and exit criteria and, if they are satisfied, enter the study.
Patients were randomly divided into 3 groups: ketamine (29 patients), doxedmodyntidine (29), and control group (29).
Blinding (investigator's opinion)
Double blinded
Blinding description
The placement of the three groups at the start of the study will be randomized; the selected patients will be divided into three groups: ketamine, dexmedmotidine and control group.
The blind is such that the only researcher knows the division of the three groups, and the participant is careful of the analyst assessor and the safety and monitoring committee is completely unaware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Amirabad
City
Tehran
Province
Tehran
Postal code
1438816391
Approval date
2018-10-26, 1397/08/04
Ethics committee reference number
IR.IUMS.FMD.REC.1397.213
Health conditions studied
1
Description of health condition studied
Posterior fusion surgery of the lumbar spine
ICD-10 code
G54
ICD-10 code description
Nerve root and plexus disorders
Primary outcomes
1
Description
Acute pain after surgery
Timepoint
Enter your recovery & 2&4&6&12 after surjery
Method of measurement
pain ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: ketamin Infusion is administered as an infusion at a dose of 0.1 mg / kg per hour.The consumable ketamines are all manufactured by Rotex Germany.As mentioned, the method of administration of the drug is infusion and the duration of administration from the beginning to the end of surgery.
Category
Treatment - Drugs
2
Description
Intervention group2: dexmedetomidine Infusion is administered as an infusion at a dose of 0.2 mg / kg per hour.Consumer dexmedetomidines are all manufactured by Exir Iran and manufactured in Boroujerd factory.As mentioned, the method of administration of the drug is infusion and the duration of administration from the beginning to the end of surgery.
Category
Treatment - Drugs
3
Description
Control group:This group of patients does not receive any analgesic during surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool-Akram Hospital
Full name of responsible person
Mohamad Saleh Sadri
Street address
Satarkhan
City
Tehran
Province
Tehran
Postal code
1438814648
Phone
+98 21 6435 2325
Email
Painresearch.center@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazem Malakouti
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86709
Email
malakouti.k@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Nasim Nikoubakht
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.24,kashfian ave.,sheykhbahayy ave.,molasadra ave.,tehran town
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8862 9854
Fax
Email
nikoobakht.n@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Nikoubakht
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.24,kashfian ave.,sheykhbahayy ave.,molasadra ave.,tehran town
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8862 9854
Fax
Email
nikoobakht.n@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Nikoubakht
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.24,kashfian ave.,sheykhbahayy ave.,molasadra ave.,tehran town
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8862 9854
Fax
Email
nikoobakht.n@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available