Determining the effect of respiratory tidal volume on the required dose of remifentanil to create controlled hypotension in rhinoplasty surgery.
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 2-3 on 40 patients
Settings and conduct
In this randomized double-blind clinical trial study, 40 eligible patients, referring to Al-Zahra and Kashani hospitals in Isfahan, will be included in the study and will be randomly divided into two groups. Then the patients will be divided according to the minimum and maximum respiratory tidal volume dose and will receive remifentanil. Then the hemodynamic parameters and respiratory complications of the patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria include candidate patients for rhinoplasty, aged 18-65 years, weigh more than 50 kg, having an American Association of Anesthesiologists (ASA) class equal to I, and informed consent to participate in the study. Exclusion criteria include addiction to opioid products, comorbidity disease (such as respiratory and coagulation disease) and a history of allergy to the study drug.
Intervention groups
First intervention group: In this group, the minimum tidal volume is selected based on the ideal weight (6cc/kg). Then remifentanil (according to routine) is given to cause hypotension and the appropriate dose is determined according to the patient's average blood pressure based on ideal body weight.
The second intervention group: In this group, the maximum tidal volume is selected based on the ideal weight (10cc/kg). Then remifentanil (according to routine) is given to cause hypotension and the appropriate dose is determined according to the patient's average blood pressure based on ideal body weight.
Main outcome variables
Blood pressure; Heart beat; Satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N71
Registration date:2023-10-08, 1402/07/16
Registration timing:prospective
Last update:2023-10-08, 1402/07/16
Update count:0
Registration date
2023-10-08, 1402/07/16
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2024-04-17, 1403/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of respiratory tidal volume on the required dose of remifentanil to create controlled hypotension in rhinoplasty surgery
Public title
Effect of respiratory tidal volume on the required dose of remifentanil to create controlled hypotension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for rhinoplasty
Age group 18-65 years
Weight more than 50 kg
American Society of Anesthesiologists (ASA) class is equal to I
Informed consent to participate in the study
Exclusion criteria:
Being addicted to opioid products
Having the comorbidity (such as respiratory and coagulation disease)
History of allergy to the studied drug
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 40 eligible rhinoplasty candidate patients are randomly selected. For this, the letter A is written on 20 sheets and the letter B is written on 20 sheets, and each of them is placed in an envelope. Each patients is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to achieve the double-blind study, the respiratory tidal volume is determined by another person not present in the study, and then the appropriate dose of remifentanil is prescribed to cause hypotension. The researcher is not aware of the difference in respiratory tidal volume in two groups. In addition, the patient, the person recording the clinical and basic information of the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware 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 Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2023-03-29, 1402/01/09
Ethics committee reference number
IR.MUI.MED.REC.1402.011
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
J34
ICD-10 code description
Other and unspecified disorders of nose and nasal sinuses
Primary outcomes
1
Description
Blood pressure
Timepoint
Before surgery, immediately before anesthesia and every 10 minutes during surgery until the end of surgery
Method of measurement
Monitoring device
2
Description
Blood pressure
Timepoint
Before surgery, immediately before anesthesia and every 10 minutes during surgery until the end of surgery
Method of measurement
Monitoring device
3
Description
Satisfaction
Timepoint
End of surgery
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In this group, the minimum tidal volume is selected based on the ideal weight (6 cc/kg). Then remifentanil (according to routine) is given to cause hypotension and the appropriate dose is determined according to the patient's average blood pressure based on ideal body weight.
Category
Treatment - Drugs
2
Description
The second intervention group: In this group, the maximum current volume is selected based on the ideal weight (10cc/kg). Then remifentanil (according to routine) is given to cause hypotension and the appropriate dose is determined according to the patient's average blood pressure based on ideal body weight.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Alireza Hoghooghi
Street address
Soffe Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alireza.hoghooghy@gmail.com
2
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Alireza Hoghooghi
Street address
Kashani street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
alireza.hoghooghy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Alireza Hoghooghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alireza.hoghooghy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Hoghooghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alireza.hoghooghy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Damanpak rizi
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mahda.damanpak@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD