Protocol summary

Study aim
Comparison of the effect of low-dose naloxone infusion on hemodynamic factors and surgical field bleeding in patients under general anesthesia with remifentanil and propofol infusion.
Design
This study is a controlled clinical trial with parallel, double-blind, randomized groups on 114 patients. Block randomization method is used for randomization.
Settings and conduct
This study is a randomized clinical trial and will be performed after the approval of the ethics committee of Tehran University of Medical Sciences. After prescribing premedication and standard monitoring, induction of anesthesia is performed. To maintain anesthesia, infusion of remifentanil (1 μg / kg / min) and propofol in a dose 150 μg / kg / min are used. In the intervention group, naloxone (0.25 g / kg / h) prepared in 10 ml of normal saline is infused during the operation using a syringe pump. In the control group, 10 ml of normal saline is infused using a syringe pump during the operation. Systolic and diastolic blood pressure, heart rate in the time before induction are recorded, then systolic and diastolic blood pressure, heart rate, cardiac output, stroke volume are recorded 15 minutes after induction and every 15 minutes until the end of the operation and in recovery. The surgeon's general satisfaction from the amount of bleeding during the operation at the surgical site is also evaluated and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergoing head and neck surgery Exclusion criteria: Patients addicted to Narcotics, Patients with heart failure or advanced heart disease, Patients with asthma
Intervention groups
Intervention group: Injection of low-dose naloxone infusion (0.25µg/kg/h) in 10 ml of normal saline Control group : injection of 10 ml normal saline infusion
Main outcome variables
Dose of narcotics.the surgeon's satisfaction with the surgical bleeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101122005225N10
Registration date: 2022-05-09, 1401/02/19
Registration timing: registered_while_recruiting

Last update: 2022-05-09, 1401/02/19
Update count: 0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Seyed mohammad Mireskandari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 8931
Email address
mireskandari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of low-dose naloxone infusion on hemodynamic factors and surgical field bleeding in patients under general anesthesia with remifentanil and propofol infusion.
Public title
The effect of naloxone on hemodynamic factors and bleeding rate in patients under general anesthesia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing head and neck surgery
Exclusion criteria:
Patients addicted to Narcotics Patients with heart failure or advanced heart disease Patients with asthma
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups. To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block 4, we divide patients into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Corner of Ghods Street, Keshavarz Boulevard,the headquarters of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
8874113911
Approval date
2021-09-01, 1400/06/10
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.214

Health conditions studied

1

Description of health condition studied
Head and neck surgery
ICD-10 code
C82.51
ICD-10 code description
Diffuse follicle center lymphoma, lymph nodes of head, face, and neck

Primary outcomes

1

Description
Dose of narcotics
Timepoint
During the operation
Method of measurement
View and record

Secondary outcomes

1

Description
Surgeon satisfaction with bleeding during surgery
Timepoint
During the operation
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: This study is a randomized clinical trial and will be performed after the approval of the ethics committee of Tehran University of Medical Sciences. After prescribing premedication and standard monitoring, induction of anesthesia is performed. In the intervention group, naloxone (manufactured by Tolid darou pharmaceutical company) is prepared in a dose (0.25 g / kg / h) in 10 ml of normal saline and is infused during the operation using a syringe pump. Systolic and diastolic blood pressure, heart rate in the time before induction are recorded, then systolic and diastolic blood pressure, heart rate, cardiac output, stroke volume are recorded 15 minutes after induction and then every 15 minutes until the end of the operation and in recovery .The surgeon's overall satisfaction with the amount of bleeding during the operation at the surgical site is also assessed and recorded.
Category
Treatment - Drugs

2

Description
Control group: This study is a randomized clinical trial and will be performed after the approval of the ethics committee of Tehran University of Medical Sciences. After prescribing premedication and standard monitoring, induction of anesthesia is performed. In the control group, 10 ml of normal saline is infused using a syringe pump during the operation. Systolic and diastolic blood pressure, heart rate in the time before induction are recorded, then systolic and diastolic blood pressure, heart rate, cardiac output, stroke volume are recorded , 15 minutes after induction and every 15 minutes until the end of the operation and in recovery. The surgeon's overall satisfaction with the amount of bleeding during the operation at the surgical site is also assessed and recorded.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Seyed Mohammad Mireskandari
Street address
No4, Yasaman Alley, Goleyakh Alley, Basiri St., Shariati Ave., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 2261 8931
Email
mireskandari@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
No4, Yasaman Alley, Goleyakh Alley, Basiri St., Shariati Ave., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 2261 8931
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
Seyed Mohammad Mireskandari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No4, Yasaman Alley, Goleyakh Alley, Basiri St., Shariati Ave., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 2261 8931
Email
mireskandari@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mireskandari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No4, Yasaman Alley, Goleyakh Alley, Basiri St., Shariati Ave., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 2261 8931
Email
mireskandari@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mireskandari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No4, Yasaman Alley, Goleyakh Alley, Basiri St., Shariati Ave., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 2261 8931
Email
mireskandari@sina.tums.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
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