Protocol summary

Study aim
Determine the effect of induced blood pressure reduction on cognitive function in people candidate for rhinoplasty surgery in Rafsanjan
Design
Clinical trial with a control group, parallel groups, double-blind, randomized, phase 2 on 50 patients.Random allocation software will be used for randomization.
Settings and conduct
Patients are randomly divided into two groups A and B. Induced hypotension will applied by Remifentanil, in group A but it is not applied in group B, and by tranxamic acid will be used to control bleeding. In this study, the researcher, person who responsible for following up the patients, the statistician were blind to the study.
Participants/Inclusion and exclusion criteria
Patients between the ages of 15 and 45, with the ability to read and write and "American society of anesthesiology" class,2, can enter this study. If the patients do not want to participate in the study, the history of blood coagulation disorder or the occurrence of anesthesia complication during surgery, such as airway spasm or desaturation, the subject will be excluded from the study.
Intervention groups
In the intervention group (group A), remifentanil was used in order to reduce blood pressure, to control bleeding at the operation site, and the dose of remifentanil was adjusted so that the mean arterial pressure was decrease more than 30% of the bloop pressure before anesthesia induction or mean blood pressure decreases to 50 to 65. In the control group (group B), induced blood pressure is not given so that the patient's blood pressure is maintained above 50 to 65 mm Hg or lower than 30% of the initial blood pressure.
Main outcome variables
The individual's cognitive performance is compared by "minimum mental status test", Beck questionnaire and Paced Auditory Serial Addition Test (PASAT) after surgery in two groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230703058656N3
Registration date: 2024-08-01, 1403/05/11
Registration timing: retrospective

Last update: 2024-08-01, 1403/05/11
Update count: 0
Registration date
2024-08-01, 1403/05/11
Registrant information
Name
Bahar Noori-Rahmatabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 6194
Email address
baharnoori64@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-21, 1402/04/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of induced hypotension and normal blood pressure on Cognitive Function in patients candidate for rhinoplasty surgery
Public title
Effect of induced hypotension on Cognitive function in patients candidate for rhinoplasty surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18-45 years old Patients in the "American society of anesthesiology" class-1,2 Ability to read and write
Exclusion criteria:
Unwillingness to precipitate in the study History of coagulation disorder Anesthesia complications during surgery, such as airway spasm or Respiratory desaturation or hypoxemia
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Base on "Random allocation software" patients are randomly divided into groups A and B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Based on the Random computer software, the patients are divided into groups, A and B. Induce hypo-tension is applied in group A. Participants, intervention outcome assessors, and researchers aware who is in group A or B, but none of them aware that whatever intervention group is group A or B. Finally, after interpretation of the results by the statistician, the observer reveals each name belonged to which group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
the Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd, Central Organization of the University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2024-06-26, 1403/04/06
Ethics committee reference number
IR.RUMS.REC.1403.045

Health conditions studied

1

Description of health condition studied
Dysfunction after induce hypotension during operation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The mini–mental state examination (MMSE) score
Timepoint
Before surgery and one day-one month after surgery
Method of measurement
The mini–mental state examination (MMSE) or Folstein test

2

Description
Paced Auditory Serial Addition Test score
Timepoint
Before surgery and one day-one month after surgery
Method of measurement
Paced Auditory Serial Addition Test

3

Description
Beck Depression Inventory-II score
Timepoint
Before surgery and one day-one month after surgery
Method of measurement
Beck Depression Inventory-II

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group A: Genral Anesthesia induced by Midazolam:2mg, Propofol:2-2.5 mg, Atracurium:0.5 mg/kg, fentanyl: 2-3 ugr. and maintenance of anesthesia hold by Isoflurane.By Remifentanil Blood pressure during surgery is decreased to less than 30% of the patient's initial blood pressure before anesthesia induction l. If induced hypotension would failed and heart rate above 60, Labetalol 5 mg every 5 minutes and if the patient's heart rate is less than 60, Nitroglycerin is used. Sever hypotension will treated by Fluid Therapy and ephedrine.
Category
Treatment - Drugs

2

Description
Control group: Group B, Genral Anesthesia induced by Midazolam:2mg, Propofol:2-2.5 mg, Atracurium:0.5 mg/kg, fentanyl: 2-3 ugr. and maintenance of anesthesia hold by Isoflurane. Blood Pressure control in the range of 30% of the Blood pressure before anesthesia. If surgical bleeding occur control by Tranexamic cid: 500-1000mg.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Moradi Hospital
Full name of responsible person
Alireza Nazari
Street address
Shohada st
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3426 0083
Email
Baharnoori64@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vaziri-Nejad
Street address
Central Organization of the university of medical Sciences, Imam Ali-Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Bahar Noori-Rahmatabadi
Position
Assistance professor of Anesthesiology&Intensive care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.68, East Emam Sajad Alley-1, Emam Sajad Blvd, Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7717943816
Phone
+98 34 3428 6194
Email
baharnoori64@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Bahar Noori-Rahmatabadi
Position
Assistance professor of Anesthesiology&Intensive care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.68, East Emam Sajad Alley-1, Emam Sajad Blvd, Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7717943816
Phone
009834286194
Email
baharnoori64@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Bahar Noori-Rahmatabadi
Position
Assistance professor of Anesthesiology&Intensive care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.68,East Emam Sajad Alley-1, Emam Sajad Blvd, Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7717943816
Phone
009834286194
Email
baharnoori64@yahoo.com

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After making the participants unidentifiable, demographic information and the main outcome of the study, include the cognitive function of patients before and after rhinoplasty surgery, will be published.
When the data will become available and for how long
The access period starts 18 months after the results are published
To whom data/document is available
The findings and documentation of the article will be available to health researchers and the general public.
Under which criteria data/document could be used
Any analysis on the released data is permitted
From where data/document is obtainable
The e-mail address and postal address of the corresponding author of the article will be announced, and the data and documentation will be provided to the requester by the corresponding author.
What processes are involved for a request to access data/document
After the email request for data and documents, they will be delivered maximum within six months
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