IRCT | Comparison of intravenous propofol-remifentanil anesthesia and inhalational isoflurane-remifentanil anesthesia on QTc interval in patients receiving methadone maintenance therapy who are candidate for open limbs surgery.

Protocol summary

Study aim: Comparison of intravenous propofol-remifentanil anesthesia and isoflurane inhalational anesthesia on QTc interval in patients receiving methadone maintenance therapy who are candidate for open limbs surgery
Design: Double blind randomized clinical trial, Sixty participants with inclusion criteria after justification and informed concern assign in intervention or control group.
Settings and conduct: This study performs in operation rooms of Imam Hossein Hospital, . Anesthesiologist and nurse anesthesia are aware of patient's group and record in questionnaire. Questionnaire has two portion (demographic and data recording portion) with identical cod. They seperate data recording portion and gives it to person who is responsible of outcome recording and is unaware of patient grouping.(syringes pump and isoflurane vaporizer have covers)Data analysig investigator is also unaware of patient's grouping.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Male, Age 18 - 60 Methadone maintenance therapy with a dose of at over 50 mg per day Open limbs surgery under general anesthesia Class 1 and 2 of anesthesia risk Exclusion criteria: Use of every drug except methadone in last week Moderate and severe systemic disorders( anesthesia risk over 2) Every preoperative abnormal heart rate and rhythm. Need for injection of any drug out of study protocol
Intervention groups: Intervention group: Maintenance of anesthesia performs with Intravenous propofol-remifentanil (propofol 100 g / kg / min with remifentanil 1 microgram / kg / min) And the dose of the propofol will be adjusted based on the depth of anesthesia. Control group: Maintenance of anesthesia performs with inhalational isoflurane and intravenous remifentanil (1.2% isoflurane and 1 microgram/kg/min remifentanil).The dose of isoflurane will be adjusted based on the depth of anesthesia.
Main outcome variables: QT interval

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200524047560N1

Registration date: 2021-01-02, 1399/10/13

Registration timing: registered_while_recruiting

Last update: 2021-01-02, 1399/10/13

Update count: 0
Registration date: 2021-01-02, 1399/10/13

Registrant information: Name

Javad Amiri

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 23 3223 8718

Email address

javadamiri94@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2020-09-22, 1399/07/01
Expected recruitment end date: 2021-01-04, 1399/10/15
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of intravenous propofol-remifentanil anesthesia and inhalational isoflurane-remifentanil anesthesia on QTc interval in patients receiving methadone maintenance therapy who are candidate for open limbs surgery.

Public title: Comparison of propofol intravenous anesthetic and Isoflurane inhalational anesthetic on QTc interval in ECG of patients receiving methadone maintenance therapy who are candidate for open limbs surgery.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Male Age 18 - 60 Methadone maintenance therapy with a dose of at over 50 mg per day Open limbs surgery under general anesthesia Class 1 and 2 of anesthesia risk (According to American society of anesthesiologist's classification) Normal preoperative heart rate and rhythm

Exclusion criteria:

Use of every drug except methadone in last week Moderate and severe systemic disorders( anesthesia risk over 2) Every abnormal heart rate and rhythm Need for injection of a drug that changes routine anesthesia protocol.
Age: From 18 years old to 60 years old
Gender: Male

Phase

3

Groups that have been masked

Participant
Investigator
Outcome assessor

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

After informed concern participants, according quadruple blocks randomization assigns to control or intervention group. Sixty envelope (30 of them with letter A=Intervention and other 30 envelop with letter B= control based on the randomization table is provided and for each participant corresponding envelope is given to the anesthesiologist by person who is responsible for randomization. Anesthetist, records the group's type in participant's questionnaire and then the envelope is left out.

Blinding (investigator's opinion)

Double blinded

Blinding description

Anesthesiologist and nurse anesthesia are aware of patient's group and this group is recorded in questionnaire by them. Questionnaire has two portion with identical cod. Nurse anesthesia separates data recording portion and gives it to person who is responsible of outcome recording and is unaware of patient grouping. (syringes pump and isoflurane vaporizer have cover.)

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Shahroud University of Medical Sciences

Street address

Shahroud, 7th of Tir Square - Shahroud University of Medical Sciences and Health Services

City

Shahroud

Province

Semnan

Postal code

36147-73947
Approval date: 2020-11-30, 1399/09/10
Ethics committee reference number: IR.SHMU.REC.1399.121

Health conditions studied

1

Description of health condition studied: Open reduction and internal fixation of limbs under general anesthesia in methadone maintenance treatment patients.
ICD-10 code: S52.4
ICD-10 code description: Fracture of shaft of radius

Primary outcomes

1

Description: QT interval
Timepoint: Preoperative - 20 minutes after induction of anesthesia - After recovery
Method of measurement: Record of lead_2 of electrocardiogram

2

Description: Pulse rate
Timepoint: Preoperative - 20 minutes after induction of anesthesia - After recovery
Method of measurement: Record of lead_2 of electrocardiogram

Secondary outcomes

1

Description: Corrected QT
Timepoint: Preoperative- 20 minutes after induction of anesthesia- end of recovery
Method of measurement: QTc calculator software using QT and pulse rate

Intervention groups

1

Description: Intervention group: 30 men between the ages of 18 and 60 undergoing maintenance treatment with a minimum dose of 50 mg daily of methadone requiring surgery and under intravenous anesthesia propofol-remifentanil (propofol 100 g / kg / min with remifentanil 1 g / kg / min) And the dose of the drug will be adjusted based on the depth of anesthesia.In this study we use from propofol ( Claris Lifescience limited, India by Daya darou Co.), Isoflurane(Primal critical care inc. USA by Exir Co.) and Remifentanil (GSK by Jahan behbood Co.).
Category: Treatment - Drugs

2

Description: Control group: 30 men between the ages of 18 and 60 undergoing maintenance therapy with a minimum dose of 50 mg daily of methadone who require surgery and will undergo isoflurane-remifentanil inhalation anesthesial (Isoflurane 1.2% with remifentanil 1 microgram /kg/min) and the dose of isoflurane will be adjusted based on the depth of anesthesia.In this study we use from propofol ( Claris Lifescience limited, India by Daya darou Co.), Isoflurane(Primal critical care inc. USA by Exir Co.) and Remifentanil (GSK by Jahan behbood Co.).
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Imam Hossein Educational and Research Center

Full name of responsible person

Javad Nourian

Street address

End of Ayatollah Towheedi Blvd.

City

Shahroud

Province

Semnan

Postal code

361691115

Phone

+98 23 3234 2000

Fax

+98 23 3233 3902

Email

javadnourian@shmu.ac.ir

Web page address

https://shmu.ac.ir/emh/fa

1

Sponsor: Name of organization / entity

Shahroud University of Medical Sciences

Full name of responsible person

Dr. Mohammad Hasan Emamian

Street address

Haft Tir Square Shahroud University of Medical Sciences

City

Shahroud

Province

Semnan

Postal code

36166-35866

Phone

+98 23 3223 8718

Email

javadamiri94@gmail.com

Web page address

https://shmu.ac.ir/fa/contactus
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shahroud 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

Shahroud University of Medical Sciences

Full name of responsible person

Javad Nourian

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Anesthesiology

Street address

End of Ayatollah Towheedi Blvd

City

Shahroud

Province

Semnan

Postal code

3616911151

Phone

+98 23 3234 2001

Fax

+98 23 3233 3902

Email

javadnourian@gmail.com

Web page address

https://shmu.ac.ir/emh/fa

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shahroud University of Medical Sciences

Full name of responsible person

Javad Nourian

Position

Assistant professor

Latest degree

Specialist

Other areas of specialty/work

Anesthesiology

Street address

IH Hospital, End of Ayatollah Towheedi Blvd.

City

Shahroud

Province

Semnan

Postal code

36166-35866

Phone

+98 23 3234 2001

Fax

+98 23 3233 3902

Email

javadnourian@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Shahroud University of Medical Sciences

Full name of responsible person

Javad Amiri

Position

Student

Latest degree

Master

Other areas of specialty/work

Others

Street address

Roudaki St. 7, No. 7

City

Shahroud

Province

Semnan

Postal code

36166-35866

Phone

0098 23322328718

Email

javadamiri94@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: No - There is not a plan to make this available
Statistical Analysis Plan: No - There is not a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: No - There is not a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: No - There is not a plan to make this available
Title and more details about the data/document: Informed consent form will be obtained from each patient before the operation. All information can be published after identifying individuals.
When the data will become available and for how long: After completing the research and data analysis
To whom data/document is available: All researchers are interested
Under which criteria data/document could be used: Researchers whose identity is documented and who intend to use research information scientifically
From where data/document is obtainable: Dr. javad nourian - - javadnourian@gmail.com - 0098 912 173 1359 javad amiri - javadamiri94@gmail - 0098 938 155 6473
What processes are involved for a request to access data/document: 1. The researcher requests research information and data by email and sending documents of scientific degrees and documents. 2. After reviewing the individual information, the research data will be provided to the control groups after identifying them and intervening.
Comments

Comparison of intravenous propofol-remifentanil anesthesia and inhalational isoflurane-remifentanil anesthesia on QTc interval in patients receiving methadone maintenance therapy who are candidate for open limbs surgery.