Protocol summary

Study aim
Comparison of opioid requirement and pain intensity after mandibular surgeries in intraoperative infusion and bolus injection during dexmedetomidine extubation: a randomized clinical trial
Design
A clinical trial with parallel intervention groups, double-blind, randomized, on 40 patients. The sampling method is random. Randomization using a table of random numbers is the Random Allocation Software.
Settings and conduct
Among the patients referred to the Maxillofacial Surgery Department of Imam Reza Hospital In Tabriz who are candidates for mandibular surgery, they participate in the study. Patients are randomly assigned to one of the groups. In the first group, after surgery and before extubation, dexmedetomidine will be infused at the rate of 5.0 mg/kg, and in the second group, it will be injected exactly like the first group, but by bolus method. The intensity of pain during recovery, the first, second, fourth, sixth, twelfth, and twenty-fourth hours after discharge from recovery will be measured using VAS. Also, the number of times needed for opioid medication will be recorded if the pain intensity of the patients is higher than 5. The researcher is aware of the existence of two types of treatment, but he does not know which method of medicine he received in each group. Data analysts are not aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Including criteria: candidate for mandibular surgery, duration of surgery less than 4 hours Excluding criteria: sensitivity to dexmedetomidine, non-cooperation in the study
Intervention groups
Intervention 1: Injection of dexmedetomidine infusion after surgery Intervention 2: bolus injection of dexmedetomidine after surgery
Main outcome variables
The amount of pain؛ frequency of needing opioids

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220819055746N1
Registration date: 2022-08-29, 1401/06/07
Registration timing: registered_while_recruiting

Last update: 2022-08-29, 1401/06/07
Update count: 0
Registration date
2022-08-29, 1401/06/07
Registrant information
Name
Loghman Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 870 1049
Email address
dr.ebrahimi65@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-20, 1401/05/29
Expected recruitment end date
2022-09-30, 1401/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of opioid requirement and pain intensity after mandibular surgeries in intraoperative infusion and bolus injection during dexmedetomidine extubation: a randomized clinical trial
Public title
The effect of dexmedetomidine in reducing pain after jaw surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years Candidate for mandibular surgery Consent to participate in the study
Exclusion criteria:
History of allergy to dexmedetomidine Multi-trauma patients Addiction to drugs and psychoactive substances History of taking antidepressants History of previous mandible, maxilla and cheek surgery during the last three months Patients diagnosed with rheumatoid arthritis Patients with kidney and liver diseases Dialysis patients Patients receiving anticoagulant drugs Patients with a history of systemic infections Patients with hemostatic disorders
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling will be done among the patients referred to the maxillofacial surgery department of Imam Reza Hospital in Tabriz who are eligible for the study. The randomization method is simple and its unit is individual. Random numbers are our tool for randomizing. Based on this, the type of treatment is marked with code A (infusion) and B (bolus) and placed inside sealed envelopes. Then the envelopes are placed in a bag and mixed. Then it is randomly selected from the bag and treatment is given to the patient by observing the code. None of the patients will be informed about the treatment of another patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind. The injection will be done by an anesthesiologist. The researcher who will conduct the evaluation will not know about the type of intervention performed. Also, the person analyzing the data will be unaware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2022-06-27, 1401/04/06
Ethics committee reference number
IR.TBZMED.REC.1401.308

Health conditions studied

1

Description of health condition studied
Fracture of mandible
ICD-10 code
S02.6
ICD-10 code description
Fracture of mandible

Primary outcomes

1

Description
Pain intensity
Timepoint
during recovery, the first, second, fourth, sixth, twelfth and twenty-fourth hours after discharge from recovery
Method of measurement
Visual Analogue Scale

2

Description
The amount of using opioid
Timepoint
during recovery, the first, second, fourth, sixth, twelfth and twenty-fourth hours after discharge from recovery
Method of measurement
The amount of pain during recovery is measured in the first, second, fourth, sixth, twelfth and twenty-fourth hours after discharge from recovery. If the Visual Analogue Scale is higher than 5, pethidine (Exir-Iran company) at the rate of 1 mg/kg will be injected intramuscularly. After four hours, in case of recurrence of pain, the pethidine injection will be repeated at the rate of 1mg/kg. The number of times the patient needs pethidine in twenty-four hours will be recorded.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After surgery and before extubation, 5.0 mg/kg of dexmedetomidine will be infused. VAS will be measured. Also, the number of times needed for opioid medication will be recorded if the pain intensity of the patients is higher than 5.
Category
Treatment - Drugs

2

Description
Intervention group: After surgery and before extubation, 5.0 mg/kg dexmedetomidine will be injected by bolus method. Pain intensity during recovery, first, second, fourth, sixth, twelfth, and twenty-fourth hours after discharge from Recovery will be measured using VAS. Also, the number of times needed for opioid medication will be recorded if the pain intensity of the patients is higher than 5.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Tabriz Hospital
Full name of responsible person
Saeed Nezafati
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
nezaf2000@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mozhgan Kachuei
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
nezaf2000@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Saeed Nezafati
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
nezaf2000@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeed Nezafati
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
nezaf2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeed Nezafati
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
nezaf2000@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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