Evaluation of the effect of remifentanil on pain and delirium in patients with spinal surgery
Evaluation of the effect of Methadone on pain and delirium in patients with spinal surgery
Evaluation of the effect of Sufentanil on pain and delirium in patients with spinal surgery
Design
A randomized, blinded, sham controlled clinical trial with three parallel groups design of 120 patients with concealed Randomisation sequence carried out at rand-function from Excel Application
Settings and conduct
Briefly after surgery has been done clinicians inject The Pain Relief Medications in order to manage The Pain after Surgery. In this clinical trial on 120 Patients with Spinal Surgery referred to Imam Khomeini hospital of Ilam, IR from January 2000 to march 2001, we try to evaluate Patients Information of Severity and Duration of Delirium collected from their physical examination and their Pain Score by VAS after Surgery, 6, 12, and 24 Hours later, in three Intervention Groups taking:1-remifentanil 2-sufentanil 3-Methadone and report the results.
Participants/Inclusion and exclusion criteria
Participants: Patients with Spinal Surgery
Inclusion Criteria:
Patients with Spinal Surgery taking Remifentanil
Patients with Spinal Surgery taking Sufentanil
Patients with Spinal Surgery taking Methadone
Exclusion Criteria:
Patients with History of Psychological Disorders
Patients with History of Drug Addiction
Patients with History of Allergic Reaction to Drugs
Patients with History of Diabetes Mellitus
Patients with History of Kidney Disease
Intervention groups
First Group: Patients with Spinal Surgery taking Remifentanil
Second Group: Patients with Spinal Surgery taking Sufentanil
Third Group: Patients with Spinal Surgery taking Methadone
Main outcome variables
Pain Score and Delirium Duration and Severity of Patients With Spinal surgery taking: Remifentanil; Sufentanil and Methadone.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221218056854N1
Registration date:2023-01-23, 1401/11/03
Registration timing:registered_while_recruiting
Last update:2023-01-23, 1401/11/03
Update count:0
Registration date
2023-01-23, 1401/11/03
Registrant information
Name
Hamid Reza Zanji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3422 4443
Email address
hamidzanji1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the mean effect of Remifentanil, Methadone, and Sufentanil on Pain and Delirium in Patients with spinal surgery
Public title
Comparison of the mean effect of Remifentanil, Methadone, and Sufentanil on Pain and Delirium in Patients with spinal surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with spinal surgery taking Remifentanil
Patients with spinal surgery taking Sufentanil
Patients with spinal surgery taking Methadone
Exclusion criteria:
Patients with Psychological History
Patients with History of Drug Addiction
Patients with History of Allergic Reaction to Drugs
Patients with History of Diabetes
Patients with History of Kidney Disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The Patients with Spinal Surgery whom are entering the study are divided to three groups and receive Remifentanil, Sufentanil and Methadone randomly and they aren't aware of which kind of drugs they receive and the other Patients Information(are blinded).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences
Street address
Yas building 4th floor. Golha Sq. Ilam. IR Iran
City
Ilam
Province
Ilam
Postal code
6931371549
Approval date
2022-11-14, 1401/08/23
Ethics committee reference number
IR.MEDILAM.REC.1401.173
Health conditions studied
1
Description of health condition studied
multiple fractures of spine, level unspecified
ICD-10 code
T08
ICD-10 code description
Fracture of spine, level unspecified
Primary outcomes
1
Description
Delirium Severity and Duration
Timepoint
After Spinal Surgery, 6, 12, and 24 Hours After Surgery
Method of measurement
Physical Examination
2
Description
Four Main Delirium Features
Timepoint
After Spinal Surgery, 6, 12 and 24 Hours After Surgery
Method of measurement
CAM-ICU(Confusion Assessment Method for the Intensive Care Unit) Questionnaire
3
Description
Pain Intensity Score
Timepoint
After Spinal Surgery, 6, 12 and 24 Hours After Surgery
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with spinal surgery whom received Remifentanil Infusion as Remifentanil Hydrochloride I.V. 1mg, sold under the brand name EPAXIR, Exir Pharmaceutical Co. with Dosage: 0.05 to 2 μg/kg Injected at the surgery time and 30 minutes after anesthesia
Category
Rehabilitation
2
Description
Intervention group: patients with spinal surgery whom received Sufentanil Infusion as Sufentanil Citrate I.V. 50μg sold under the brand name SUFIJECT, Aburaihan Pharmaceutical Co. with Dosage: 2.5 to 15 μg/kg Injected at the surgery time and 30 minutes after anesthesia
Category
Rehabilitation
3
Description
Intervention group: patients with spinal surgery whom received Methadone Infusion as Methadone Hydrochloride I.V. 5mg/ml sold under the brand name Methadone, Darou Pakhsh Pharmaceutical Co. with Dosage: 20mg Injected at the surgery time and 30 minutes after anesthesia
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Hedaiat Heidarizad
Street address
Heidarizad Blvd, Ilam, IR
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 1933
Email
crdcemam@medilam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Sobhan Ghafourian
Street address
Banganjab Blvd, Ilam University Of Medical Science, Ilam, IR
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7120
Fax
+98 84 3222 3079
Email
sci@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Hamidreza Zanji
Position
Medical Student, Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 1,Yas Building 4th Floor, Golha Sq, Ilam
City
Ilam
Province
Ilam
Postal code
6931371549
Phone
+98 84 3422 4443
Email
hamidzanji1997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Lida Nouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 13, Modares St, Modares Blvd, Ilam, IR
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 1933
Email
nouri-l@medilam.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Hamidreza Zanji
Position
Medical Student, Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Yas Building 4th Floor, Golha Sq, Ilam
City
Ilam
Province
Ilam
Postal code
6931371549
Phone
+98 84 3422 4443
Email
hamidzanji1997@gmail.com
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