IRCT | Evaluation effects of intraoperative injection of diphenhydramine and dexmedetomidine infusion at the end of the operation - on the control of agitation in patients after general anesthesia in orthognathic surgery.

Protocol summary

Study aim: Investigating the effectiveness of prophylactic adminstration of diphenhydramine, and dexmedetomidine during anesthesia, on theemergence agitation of patients during extubation and the quality of recovery after orthognathic surgeries.
Design: Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2-3 on 80 patients. Computer Generated Table was used for randomization.
Settings and conduct: Candidate patients for orthognathic surgery in Sina Hospital, Tehran are divided into two groups: dexmedetomidine (D) and Control (C). Before anesthesia , 0.5 mg/kg diphenhydramine is injected (IV). Group C, the same volume of normal saline is injected. Both groups receive 8 mg of dexamethasone IV and during 15 min end of surgey, the remifentanil was stopped, the isoflurane was reduced to50%, and the dexmedetomidine was started at a rate of 1 µg/kg/min. In the control group, normal saline drip is used at the end of operation.
Participants/Inclusion and exclusion criteria: Inclusion criteria: 1- Age 18 to 60 years. 2- Elective orthognathic surgery. 3- Consent to participate in the study. Exclusion criteria : 1- Drug addiction 2- Uncontrolled diabetes 3- Uncontrolled blood pressure 4- Glaucoma 5- History of allergy to antihistamine
Intervention groups: Intervention group: Intravenous diphenhydramine at the beginning of anesthesia, and dexmedetomidine during the last 15 minutes of surgery to reduce patient agitation during extubation and reduce postoperative pain. Control group: The control group receives normal saline instead of diphenhydramine and dexmedetomidine.
Main outcome variables: The degree of sedation of the patients is evaluated based on the Ramsy sedation scale during trachealextubation, the degree of analgesia of the patients is evaluated based on the vissule analog scale and total analgesia requirement during recovery and 24 hours after the operation.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20130304012695N19

Registration date: 2024-05-03, 1403/02/14

Registration timing: prospective

Last update: 2024-05-03, 1403/02/14

Update count: 0
Registration date: 2024-05-03, 1403/02/14

Registrant information: Name

mohammadreza khajavi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 6312 1220

Email address

khajavim@tums.ac.ir

Recruitment status: recruiting
Funding source

Expected recruitment start date: 2024-05-30, 1403/03/10
Expected recruitment end date: 2025-07-21, 1404/04/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluation effects of intraoperative injection of diphenhydramine and dexmedetomidine infusion at the end of the operation - on the control of agitation in patients after general anesthesia in orthognathic surgery.

Public title: Efficacy of prophylactic adminstration of diphenhydramine and dexmedetomidine during anesthesia on emergence agitation and quality of recovery after Orthognathic surgeries.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age 18-60 years patients candidate for orthognathic surgery Consent to participate in the study

Exclusion criteria:

Uncontrolled diabetes Uncontrolled blood pressure Glaucoma disease Any allergy to antihistamines Opiods drug adiction
Age: From 18 years old to 60 years old
Gender: Both

Phase

2-3

Groups that have been masked

Participant
Investigator
Outcome assessor

Sample size

Target sample size: 80

Randomization (investigator's opinion)

Randomized

Randomization description

To randomize patients with inclusion criteria Block balanced randomization is used.Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms four blocks for the intervention and control group.

Blinding (investigator's opinion)

Double blinded

Blinding description

A person who prepares drugs for injection، add a code to every single medicine . The person who injects the drug does not know the code. The patient is not aware of the type of injectable medication. The researcher is not aware of the type of drug during the study.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committee of Sina Hospital - Tehran University of Medical Sciences

Street address

Sina Hospital, Imam Khomeini st.

City

Tehran

Province

Tehran

Postal code

1136746911
Approval date: 2024-05-01, 1403/02/12
Ethics committee reference number: https://ethics.research.ac.ir/IR.TUMS.SINAHOSPITAL.REC.1403.010

Health conditions studied

1

Description of health condition studied: Sedation and analgesia effects of diphenhydramine and dexmedetomidine in orthognathic surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: severity of postoperative agitation
Timepoint: During extubation and 5, 15, 30 and 60 minutes after surgery
Method of measurement: Ramsy sedation Scale

2

Description: severity of postoperative pain
Timepoint: During extubation and 5, 15, 30 and 60 minutes after surgery
Method of measurement: Visual Analogue Scale

3

Description: Hemodynamic changes
Timepoint: During extubation and 5, 15, 30 and 60 minutes after surgery
Method of measurement: Blood pressure and Heart Rate

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: Diphenhydramine drug was injected intravenously before the start of anesthesia and dexmedetomidine drip was infused to the patient 15 minutes after surgery, and the degree of agitation, pain, hemodynamic changes during extubation and the degree of pain during recovery and the total amount of analgesia consumption during 24 hours after Surgery is recorded.
Category: Prevention

2

Description: Control group: : Normal saline was injected intravenously before the start of anesthesia and normal saline drip was infused to the patient 15 minutes after surgery and the degree of agitation, pain, hemodynamic changes during extubation and the degree of pain during recovery and the total amount of analgesia consumption during 24 hours It is registered after surgery.
Category: Prevention

Recruitment centers

1

Recruitment center: Name of recruitment center

Sina Hospital

Full name of responsible person

Mohammad Reza khajavi

Street address

Sina Hospital Hassan Abad sq, Emmam Khomini st.

City

Tehran

Province

Tehran

Postal code

1136746911

Phone

+98 21 6634 8555

Email

khajavim@tums.ac.ir

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Ali Akbari Sari

Street address

Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.

City

Tehran

Province

Tehran

Postal code

1417653761

Phone

+98 21 8163 3685

Email

vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tehran 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

Tehran University of Medical Sciences

Full name of responsible person

Mohammad Reza Khajavi

Position

Anesthesiologist

Latest degree

Specialist

Other areas of specialty/work

Anesthesiology

Street address

Imam khomeni St, Hasan Abad Sq, Sina hospital

City

Tehran

Province

Tehran

Postal code

1136746911

Phone

+98 21 6312 0000

Fax

+98 21 6634 8553

Email

khajavim@tums.ac.ir

Web page address

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Mohammad Reza Khajavi

Position

Anesthesiologist

Latest degree

Specialist

Other areas of specialty/work

Anesthesiology

Street address

Imam khomeni St, Hasan Abad Sq, Sina hospital

City

Tehran

Province

Tehran

Postal code

1136746911

Phone

+98 21 6312 0000

Fax

+98 21 6634 8553

Email

khajavim@tums.ac.ir

Web page address

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Mohammad Reza Khajavi

Position

Anesthesiologist

Latest degree

Specialist

Other areas of specialty/work

Anesthesiology

Street address

Imam khomeni St, Hasan Abad Sq, Sina hospital

City

Tehran

Province

Tehran

Postal code

1136746911

Phone

+98 21 6312 0000

Fax

+98 21 6634 8553

Email

khajavim@tums.ac.ir

Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: No - There is not a plan to make this available
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: No - There is not a plan to make this available
Title and more details about the data/document: Main outcome data of the study
When the data will become available and for how long: One year after completing the study
To whom data/document is available: University and industry researchers
Under which criteria data/document could be used: Sharing experiences
From where data/document is obtainable: Dr. Khajavi's email address is khajavim@tums.ac.ir
What processes are involved for a request to access data/document: Request by email and response within one month
Comments

Evaluation effects of intraoperative injection of diphenhydramine and dexmedetomidine infusion at the end of the operation - on the control of agitation in patients after general anesthesia in orthognathic surgery.