1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effects of sevoflurane with Remifentanil plus Propofol on recovery conditions in adolescent patient with movement disorders candidate for dental treatment under general anesthesia.

Protocol summary

Study aim
Determining comparative study of recovery conditions in adolescent patient with movement disorders under general anesthesia with two pharmacological diets of sevoflurane with remifentanil plus propofol
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 30 patients. The random number table is used for randomization.
Settings and conduct
The person evaluating the recovery conditions and the participants are unaware of the type of drug injected. For this purpose, the injector and the person evaluating the recovery conditions are different. This study is done in the operating room of the Faculty of Dentistry of Isfahan University of Medical Sciences. Adult patients with movement disorders to perform dental work under general anesthesia, after clinical evaluation by an anesthesiologist and filling out a general information questionnaire and consent form, enter the study. Using a Random number table, they fall into the category of intervention or control. Ricovery conditions are then assessed with the "Nursing Delirium Screening Scale" checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The desire to participate in the study, Patients over 18 years of age, Patients with movement disorders, Patients are candidates for dental treatment under general anesthesia Exclusion criteria: People who are allergic to eggs or soy, Known allergies, Chronic diseases including heart disease, bleeding disorders, liver disease and kidney disease
Intervention groups
Intervention group: To maintain anesthesia, sevoflurane drug with MAC: 1.85 is used. Control group: To maintain anesthesia, Rimifentanil is taken with Propofol (Propofol: 3 mg / kg body weight, followed by Remifentanil: 1 μg / kg body weight per minute).
Main outcome variables
Recovery period; The amount of delirium

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100621004224N38
Registration date: 2020-05-13, 1399/02/24
Registration timing: prospective

Last update: 2020-05-13, 1399/02/24
Update count: 0
Registration date
2020-05-13, 1399/02/24
Registrant information
Name
Nasser Kaviani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2858
Email address
kaviani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-26, 1399/03/06
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of sevoflurane with Remifentanil plus Propofol on recovery conditions in adolescent patient with movement disorders candidate for dental treatment under general anesthesia.
Public title
Effects of sevoflurane with Remifentanil plus Propofol on recovery conditions
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study Patients over 18 years of age Patients with movement disorders Patients are candidates for dental treatment under general anesthesia
Exclusion criteria:
People who are allergic to eggs or soy Known allergies Chronic diseases including heart disease, bleeding disorders, liver disease and kidney disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind and the injecting person and the person evaluating the recovery conditions are different. For this purpose, an out-of-study person is used to assess recovery conditions.The person evaluating the recovery conditions is not aware of the medication used for anesthesia. Participants are also unaware of the type of drug injected
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfehan University of Medical Sciences
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave., Isfehan Town,
City
Isfehsn
Province
Isfehan
Postal code
8174673461
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.756

Health conditions studied

1

Description of health condition studied
Movement disorders
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Recovery score on "Nursing Delirium Screening Scale" Checklist
Timepoint
5,10 and 15 minuts after entering recovery
Method of measurement
"Nursing Delirium Screening Scale" Checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: to maintain anesthesia, sevoflurane USP inhaled drug from Piramal Company is used. The drug is given to the patient at a dose of MAC: 1.85 through a tracheal tube with a vaporizer for the drug sevoflurane.
Category
Other

2

Description
Control group: To maintain anesthesia, Rimifentanil is taken with Propofol (Propofol: 3 mg / kg body weight, followed by Remifentanil: 1 μg / kg body weight per minute). Depending on whether the patient is shaking or shows signs of alertness in response to the situation, further injection of the drug (remifentanil: 0.5 μg per kg body weight or propofol 0.5-1 mg / kg body weight) is done. The drugs are injected within 10-15 seconds.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The operating room of the Faculty of Dentistry, Isfehan University of Medical Sciences
Full name of responsible person
Naser Kaviani
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave., Isfehan Town,
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3673 3504
Email
kaviani@dnt.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nakisa Torabinia
Street address
Faculty of Dentistry, Isfehan University of Medical Sciences, Hezarjerib Ave., Isfehan Town,
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5579
Email
Torabinia@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Naser Kaviani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave., Isfehan Town,
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3673 3504
Email
kaviani@dnt.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Naser Kaviani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave., Isfehan Town,
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5558
Email
kaviani@dnt.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Moradi
Position
University student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
No. 46, Hezarjerib Ave., Azadegan Blvd., Azadegan Alley, Isfehan Town,
City
Isfehan
Province
Isfehan
Postal code
8169833461
Phone
0098 36681988
Email
konal7039@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
Loading...