Investigating the effect of dexmedetomidine in agitation in elective upper limb orthopedic patients candidates for general anesthesia in recovery
Design
Clinical trial with a control group, parallel groups, double-blind, randomized, phase 3, on 150 patients. Simple randomization and lottery will be used for randomization.
Settings and conduct
This study will be conducted with the aim of investigating the effect of dexmedetomidine in agitation in elective upper limb orthopedic patients candidates for general anesthesia in recovery in Fatemi Hospital in Ardabil. The intervention group will receive dexmedetomidine (Exir Company) with a dose of 0.4 µg per kilogram from induction of anesthesia to extubation, and in the control group, a placebo will be used, similar to the intervention group.
Agitation and pain will be evaluated in the recovery. The placebo is similar to the original drug in terms of color, volume, and method of use, and the patients and those who evaluate the outcome will not know about the grouping done, and the study will be double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Orthopedic patients candidates for general anesthesia in elective upper surgery. Exclusion criteria: Urgent patients, Patients with uncontrolled disease.
Intervention groups
The intervention group will include orthopedic patients who are candidates for general anesthesia in upper surgeries, and the dexmedetomidine will be evaluated in the level of agitation and pain score during recovery, and the control group will use placebo and the level of agitation and pain score will also be evaluated during recovery.
Main outcome variables
agitation and pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230819059181N1
Registration date:2023-09-10, 1402/06/19
Registration timing:prospective
Last update:2023-09-10, 1402/06/19
Update count:0
Registration date
2023-09-10, 1402/06/19
Registrant information
Name
Ali Abitorabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 0209
Email address
atlantis.321@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of dexmedetomidine in agitation in elective upper limb orthopedic patients candidates for general anesthesia in recovery
Public title
Investigating the effect of dexmedetomidine in restless in orthopedic patients candidates for general anesthesia in recovery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Orthopedic patients candidates for general anesthesia in elective upper surgery
Exclusion criteria:
Urgent patients
Patients with uncontrolled disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups receiving dexmedetomidine and placebo. Simple randomization and lottery will be used for randomization. Cards and envelopes are prepared according to the number of the research sample and an equal number of names of groups A and B are recorded on each card. The cards are placed inside the letter envelopes. The lid of the letter envelopes is glued and placed inside a box. At the start of the study, according to the order of entry of the participants, the patient will take one of the envelopes from the box and will be placed in one of the two study groups based on the group written on the card.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in the intervention group will use dexmedetomidine and the control group will use placebo, similar to the intervention group. Patients and doctors who evaluate the outcome will be unaware of the type of drug received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah Ave, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2023-08-14, 1402/05/23
Ethics committee reference number
IR.ARUMS.REC.1402.127
Health conditions studied
1
Description of health condition studied
Agitation
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
Agitation
Timepoint
15 and 30 minutes after entering recovery
Method of measurement
Ricker sedation-agitation scale
Secondary outcomes
1
Description
Pain
Timepoint
15 and 30 minutes after entering recovery
Method of measurement
Visual Analog Scale
Intervention groups
1
Description
Intervention group: Will receive dexmedetomidine (Exir Company) with a dose of 0.4 µg per kilogram from induction of anesthesia to extubation.
Category
Prevention
2
Description
Control group: A placebo will be used, similar to the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital in Ardabil
Full name of responsible person
Ali Abitorabi
Street address
Fatemi hospital, Imam Khomeini street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
fatemi@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farhad Pourfarzi
Street address
Vice chancellor for research, Ardabil University of Medical Sciences, Daneshgah Ave, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3353 4757
Email
research@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Ali Abitorabi
Position
Resident of ansthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Basij Square, Ebrahimi alley, plaque 33, unit 6
City
Ardabil
Province
Ardabil
Postal code
5615794716
Phone
009845133720209
Email
atlantis.321@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Abitorabi
Position
resident of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Basij Square, Ebrahimi alley, plaque 33, unit 6
City
Ardabil
Province
Ardabil
Postal code
5615794716
Phone
009845133720209
Email
atlantis.321@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Abitorabi
Position
resident of ansthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Basij Square, Ebrahimi alley, plaque 33, unit 6
City
Ardabil
Province
Ardabil
Postal code
5615794716
Phone
009845133720209
Email
atlantis.321@yahoo.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