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IRCT20200524047560N1 IRCT 2021-01-02 Shahroud University of Medical Sciences 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. 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. 2020-09-22 anticipated 60 Complete https://irct.ir/trial/48621 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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.). 3 Open reduction and internal fixation of limbs under general anesthesia in methadone maintenance treatment patients.. Intervention 1: 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.). Intervention 2: 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.). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is If necessary, a researcher will be provided to them with my coordination.
public Javad Nourian
End of Ayatollah Towheedi Blvd
Shahroud Iran (Islamic Republic of) 3616911151 +98 23 3234 2001 javadnourian@gmail.com Shahroud University of Medical Sciences scientific Javad Nourian
IH Hospital, End of Ayatollah Towheedi Blvd.
Shahroud Iran (Islamic Republic of) 36166-35866 +98 23 3234 2001 javadnourian@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Male 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. S52.4 Fracture of shaft of radius Treatment - Drugs Treatment - Drugs 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.). 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.). QT interval. Timepoint: Preoperative - 20 minutes after induction of anesthesia - After recovery. Method of measurement: Record of lead_2 of electrocardiogram. Pulse rate. Timepoint: Preoperative - 20 minutes after induction of anesthesia - After recovery. Method of measurement: Record of lead_2 of electrocardiogram. Corrected QT. Timepoint: Preoperative- 20 minutes after induction of anesthesia- end of recovery. Method of measurement: QTc calculator software using QT and pulse rate. Shahroud University of Medical Sciences Approved 2020-11-30 Ethics Committee of Shahroud University of Medical Sciences Shahroud, 7th of Tir Square - Shahroud University of Medical Sciences and Health Services Shahroud Semnan Iran (Islamic Republic of)