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IRCT20170130032313N1 IRCT 2018-06-08 Shahroud University of Medical Sciences The effect of nitrous oxide inhaled isoferons on postoperative pain "The effect of Remifentanil propofol on postoperative pain Comparison of inhalational Isoflurane-Nitrous oxide anesthesia and intravenous Propofol-Remifentanil anesthesia on postoperative pain in open reduction and internal fixation of leg and ankle. 2018-05-23 anticipated 60 Complete https://irct.ir/trial/30909 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to randomized quadruple blocks,researcher gives a predetermined series of 60 A and B cards to the anesthetist and based on this pattern participants will assign in to either intervention (A) or control (B) group. After the examination of the patient, After examination of the patient, anesthetist gives information about this study to every participant that has inclusion criteria,, removes an envelope in the order specified (blind concealment) and based on the envelope, group A and B is determined. Researcher and analyst before the end of the study are not aware of the type of intervention in the two groups A and B and and only the type of the group is recorded in the questionnaire, Blinding description: The patient is unaware of his grouping. The analysis and analysis of the consequences are done by unknown scholars of grouping. The questionnaire consists of two parts, each containing both parts of a single code. After the anesthetic, the section containing the patient's demographic information is separated and the patient will record the outcome of the postoperative pain in the second part. 3 Postoperative pain intensity in candidal patients for open leg and ankle surgery. In both groups, the patients are kept at least 8 hours fasting and prescribed by a safe line prior to anesthesia (fentanyl, one microgram per kilogram of weight). Anesthesia starts with Propofol injection of 2mg / kg and muscle relaxation with 0.5 mg / kg atracurium injections. Then, anesthesia is performed in the intervention group: Remifentanil 0.25 μg / kg / min + Propofol 150 μg / kg / min, which is equivalent to 60 ml propofol 1% per hour and 20 ml remifentanil per hour (concentration 50 μg / ml). The patient will be ventilated with 50% oxygen. In the control group, anesthesia with nitrous oxide with oxygen (50% O2 / 50% N2O) and isoflurane (1.5%-1.2%) will continue to be carried out in both groups of cardiovascular and respiratory monitoring And the depth of anesthesia will be adjusted according to the clinical symptoms. Muscle promoter can be repeated in both groups. In recovery, pethidine pain will be given at a dose of 20 mg. After transfer to the unit, if pethidine is present, it will be prescribed 20 mg every 6 hours.. No - There is not a plan to make this available Justification or reason for not sharing IPD is All of the writers dont agree with it
public Niloofar Khoobestani
بلوار مرزداران- خیبان فرشتگان- فرشته ۲-پلاک ۷-زنگ ۱
Tehran Iran (Islamic Republic of) 14637-74514 +98 21 4422 0262 niloofar.kh71@yahoo.com Shahroud University of Medical Sciences scientific Niloofar Khoobestani
No7.Fereshteh2,Fereshtegan street,Marzdaran Blvdd
Tehran Iran (Islamic Republic of) 14637-74514 +98 21 4422 0262 niloofar.kh71@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Male or female Age between 18 until 40 ASA class 1,2 Patients with open fractures of leg & ankle 18 years 60 years Both A history of drug use and drug abuse Anticonvulsant intake, sedative, anti-depressant Any complications that change the procedure and anesthesia Treatment - Drugs In both groups, the patients are kept at least 8 hours fasting and prescribed by a safe line prior to anesthesia (fentanyl, one microgram per kilogram of weight). Anesthesia starts with Propofol injection of 2mg / kg and muscle relaxation with 0.5 mg / kg atracurium injections. Then, anesthesia is performed in the intervention group: Remifentanil 0.25 μg / kg / min + Propofol 150 μg / kg / min, which is equivalent to 60 ml propofol 1% per hour and 20 ml remifentanil per hour (concentration 50 μg / ml). The patient will be ventilated with 50% oxygen. In the control group, anesthesia with nitrous oxide with oxygen (50% O2 / 50% N2O) and isoflurane (1.5%-1.2%) will continue to be carried out in both groups of cardiovascular and respiratory monitoring And the depth of anesthesia will be adjusted according to the clinical symptoms. Muscle promoter can be repeated in both groups. In recovery, pethidine pain will be given at a dose of 20 mg. After transfer to the unit, if pethidine is present, it will be prescribed 20 mg every 6 hours. Pain score with NRS questionnaire. Timepoint: 2,4,6 hours after transfer of the ward then every 6 hours within 24 hours. Method of measurement: NRS questionnaire. Dose of pethidine prescribed. Timepoint: 2,4,6 hours after transfer to ward then every 6 hours within 24 hours. Method of measurement: NRS questionnaire. Shahroud University of Medical Sciences Approved 2016-11-09 Ethics committee of shahrud university of medical sciences Shahrud university of medical sience, Haftetir Squard Shahrud Semnan Iran (Islamic Republic of)