Protocol summary

Study aim
Comparison of the efficacy and side effects of combined doses of dexmedetomidine and propofol with isoflurane and nitrosoxide as a general anesthetic preservative in orthopedic surgeries
Design
Clinical trialwithcontrolgroup,withparallelgroups,doubleblind,randomized,phase 3 on 90 patients. For randomization using a table of random numbers are assigned to three groups A, B and C (30 people in each group). The anesthesia assistant will not know the study groups and the dose of IV and inhaled drugs. The drugs will be prepared by an anesthesiologist using labels A, B and C.
Settings and conduct
This study is a randomized clinical trial to compare the efficacy and side effectsofcombineddosesofdexmedetomidineandpropofolwithisofluraneandnitrosoxide as a general anesthetic in orthopedic surgery in patients admitted to medical centers affiliated to the University of Medical Sciences. Mazandaran will be done in 1401. The research environment is the operating room of Imam Khomeini Educational and Medical Center in Sari. The study population consists of patients who are candidates for non-emergency orthopedic surgery under general anesthesia
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-60 years, Class 1 and 2 anesthesia (ASA), Patients with complications such as hypotension, hypertension, bradycardia, pneumothorax, air embolism and decreased arterial oxygen saturation, which are possible side effects of anesthetics. , Do not have. Withdrawal conditions: Emergency surgery, known allergy to the drugs used in
Intervention groups
Patients undergoing intravenous anesthesia using the minimum combined doseofpropofolanddexmedetomidinePatientsundergoingintravenousanesthesia using the maximum combined dose of propofol and dexmedetomidine Patients will undergo inhalation anesthesia using isoflurane and nitrous oxide.
Main outcome variables
Time to wake up from anesthesia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210904052371N3
Registration date: 2022-06-20, 1401/03/30
Registration timing: prospective

Last update: 2022-06-20, 1401/03/30
Update count: 0
Registration date
2022-06-20, 1401/03/30
Registrant information
Name
Goli Aezi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 9875
Email address
gaezi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The Efficacy And Side Effects of Combined Doses of Dexmedetomidine And Propofol With Isoflurane And Nitrosoxide as a General Anesthetic Preservative in Orthopedic Surgeries
Public title
Comparison of The Efficacy And Side Effects of Combined Doses of Dexmedetomidine And Propofol With Isoflurane And Nitrosoxide as a General Anesthetic Preservative in Orthopedic Surgeries
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's desire to participate in the study and gain informed consent Candidate for non-emergency orthopedic surgery under general anesthesia Age between 18-60 years Class 1 and 2 Anesthesia (ASA) Patients who do not have complications such as hypotension, hypertension, bradycardia, pneumothorax, air embolism and decreased arterial oxygen saturation, which is a possible side effect of anesthetics
Exclusion criteria:
Emergency surgery Known allergies to the drugs used in the present study Operation longer than 5 hours Patients during the intervention if acute complications such as hypotension, hypertension, bradycardia, pneumothorax, air embolism and a decrease in arterial oxygen saturation.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria are randomly assigned (using a table of random numbers) to three groups A, B and C (30 people in each group). The anesthesia assistant will not know the study groups and the dose of IV and inhaled drugs. The drugs will be prepared by an anesthesiologist using labels A, B and C. They will be provided to the anesthesia assistant in the lower year. B Patients will undergo complete intravenous anesthesia using the maximum combined dose of propofol and dexmedetomidine. In group C, patients will undergo inhalation anesthesia using isoflurane and nitrous oxide.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study will be conducted in a double-blind method, so that neither patients nor the evaluators of the study outcomes are aware of the placement of patients in the study groups. In addition, fair people are placed in groups. Syringes prepared with different concentrations that have reached the same volumes with normal saline for bolus injection and Prepared microstructures with different concentrations (2 groups of maximum and minimum dose) that have reached the same volumes with normal saline, for infusion during operation A low-year resident or anesthesiologist present at the patient's bedside who do not know the concentration of the drug And record only clinical signs and vital signs
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Approval date
2022-04-13, 1401/01/24
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1401.008

Health conditions studied

1

Description of health condition studied
Depth of anesthesia
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

Primary outcomes

1

Description
Time to wake up from anesthesia
Timepoint
From the moment of closing the anesthetic (inhaled or intravenous) to the moment of waking the patient if the patient is able to obey instructions and communicate
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Depth of anesthesia
Timepoint
Immediately before and after induction (before starting maintenance dose), while receiving maintenance dose, when discontinuing anesthesia, moment of awakening from anesthesia, end of recovery
Method of measurement
brain function assessment

Intervention groups

1

Description
Intervention group: Group (A) for dexmedetomidine will use an initial bolus dose (0.5 μg / kg) over 10 minutes and a maintenance dose (0.5 μg / kg / h). Propofol will also be used in bolus dose (0.25 mg / kg) and maintenance dose (0.25 mg / kg / h). Propofol ampoule from Dongkook Pharaceutical COtd-company Korea and dexmedetomidine ampoules EXIR manufacturer Iran
Category
Treatment - Drugs

2

Description
Intervention group: Group (B) for dexmedetomidine will use an initial bolus dose (1 μg / kg) over 10 minutes and a maintenance dose (1 μg / kg / h). Propofol will also be used in bolus dose (1.5 mg / kg) and maintenance dose (5 mg / kg / h). In each of these groups, dexmedetomidine and propofol are combined and given to the patient.
Category
Treatment - Drugs

3

Description
Control group: To maintain anesthesia, only N2O 50% anesthetics and MAC isoflurane 1 will be used. N2O gas capsule made in Iran and Bethlehem company and isoflurane solution made in USA and from Piramel Critical care company, INC
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Goli Azzi
Street address
Amir Mazandarani St. Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
Gaezi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saedi
Street address
Joybar intersection of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3325 7230
Email
m.saedi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Goli Azzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani St. Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
Gaezi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Goli Azzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani St. Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
Gaezi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Goli Azzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani St. Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
Gaezi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir

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...