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IRCT20211206053305N1 IRCT 2022-10-10 Tehran University of Medical Sciences Evaluation of the Effect of Two Different Methods of Anesthesia on Pain and Nausea and Vomiting in Children with Cancer Evaluation and Comparison of the Effectiveness of General Anesthesia with Souffleran and Propofol on Nausea, Vomiting and Agitation after Bone Marrow Aspiration and Intrathecal Injection in Children with Cancer Referred to Bahrami Hospital. 2022-06-22 anticipated 30 Complete https://irct.ir/trial/63998 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using limited randomization method of block randomization type. The size of all the blocks is equal and in this two-group trial, the participants are assigned equally to two intervention and control groups of 15 people using blocks of 6. The randomization tool will be a random sequence generation software. In order to hide random allocation, non-transparent sealed envelopes with random sequence will be used. Each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order.Finally, the lids of the envelopes are glued and placed in a box. At the time of the registration of the participants, according to the order of entry of the eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. The person who created the random sequence will not be involved in other stages of the study, including the allocation of participants, Blinding description: Blinding of the Type of Intervention Performed in Patients Will Be Done in the Data Collection Stage (lack of knowledge of the Examiner about the Intervention Group) and the Stage of Data Analysis (lack of knowledge of the Statistical Analyst of the Type of Intervention in Each Group). Therefore, the forthcoming Study will be in the form of Triple Blind .In this Way, the Patients are Children and their Parents Do Not know about the Study Group and do not know Which Group they are in. On the other hand, the Person who Collects the Information and Registers it in the Patient Information Sheet does not know the Patient Group, and on the third hand, the Person who Analyzes the Information also does not know the Patient Group because the Patients are Divided into 2 Groups: 1 and 2 and do not know the Name of the Group. 3 Agitation and Nausea and Vomiting. Intervention 1: Intervention Group: Patients in the First Group will Receive 35 mg / kg Fentanyl Before Induction of Anesthesia. In the Next Step, They will be Induced Anesthesia by Receiving 8% Souffluran. Continuation of anesthesia is with isoflurane inhalation gas. Intervention 2: Intervention Group: Patients in the Second Group will Receive 35 mg / kg Fentanyl Before Induction of Anesthesia. In the Next Step, by Receiving Propofol at a Dose of 2 mg / kg, They will be Induced Under Anesthesia. Continuation of Anesthesia is with Isoflurane Inhalation Gas. 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 No information
public Seyedeh Mahsa Hosseini
No3,Yas Dead end, Tavanir Blvd , Valiasr Street , Tehran
Tehran Iran (Islamic Republic of) 1434874983 +98 11 5216 1764 Smahsahosseini1376@gmail.com Tehran University of Medical Sciences scientific Bita Malekianzadeh
No 3 , Yas dead end , Tavanir Ave , Valiasr Ave , Tehran
Tehran Iran (Islamic Republic of) 1434874983 +98 912 957 7267 bmalekianzadeh@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) All Children Between the Ages of 1 and 10 Have a Diagnosis of Cancer that Requires General Anesthesia for Intrathecal Injection and Bone Marrow Biopsy 1 year 10 years Both Dissatisfaction of the Patient or her/his legal Guardian to Participate in the Study Lack of Proper Cooperation of the Patient or his/her legal Guardian History of Any Past or Present lung Disease or Involvement History of Past or Present Respiratory Distress History of Any Past or Present Cardiovascular Disease Simultaneous Involvement of Any Disorders leading to Nausea and Vomiting History of Any Drug Allergies, Allergies to Eggs, Soy History of Convulsion Treatment - Drugs Treatment - Drugs Intervention Group: Patients in the First Group will Receive 35 mg / kg Fentanyl Before Induction of Anesthesia. In the Next Step, They will be Induced Anesthesia by Receiving 8% Souffluran. Continuation of anesthesia is with isoflurane inhalation gas. Intervention Group: Patients in the Second Group will Receive 35 mg / kg Fentanyl Before Induction of Anesthesia. In the Next Step, by Receiving Propofol at a Dose of 2 mg / kg, They will be Induced Under Anesthesia. Continuation of Anesthesia is with Isoflurane Inhalation Gas. Severity of Nausea and Vomiting. Timepoint: Post Operative Nausea and Vomiting will be Measured After Transferring Patients to the Recovery Room. Method of measurement: Examination. Agitation. Timepoint: Pediatric Anesthesia Emergence Delirium Score will be Measured after Transferring Patients to the Recovery Room. Method of measurement: Pediatric Anesthesia Emergence Delirium Score. Tehran University of Medical Sciences Approved 2021-06-23 Ethics Committee of Tehran University of Medical Sciences No 3, Yas dead end , Tavanir Ave , Valiasr Ave , Tehran Tehran Tehran Iran (Islamic Republic of)