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IRCT20130304012695N6 IRCT 2020-07-10 Tehran University of Medical Sciences Reduction of nausea ,vomiting and pain of bariatric surgery Evaluation of the effect of intravenous diphenhydramine injection before anesthesia induction on postoperative pain , nausea and vomiting reduction in bariatric laparoscopic surgery 2019-04-14 anticipated 38 Complete https://irct.ir/trial/49229 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: To randomize patients with inclusion criteria Block balanced randomization is used.Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms four blocks for the intervention and control group. The complete cards of the four blocks are given to the head of the operating room, who is unaware of the study, in an envelope. A card is given to the patient after patient entrance to operating room, Blinding description: Participants:Since patients are not aware of the type of study drug at the time of anesthesia induction they were blind about the group to which they were allocated. Those who evaluate the outcome:The assistant who records the results in this study does not know the type of group Data collection officials:The person who analyzes the data also does not know the type of participating groups. 2-3 Condition 1: Abdominal Acute Pain after laparoscopic bariatric surgery. Condition 2: Postoperative nausea and vomiting. Intervention 1: Intervention group: 0.5 mg/kg of diphenhydramine is injected intravenously before anesthesia and the degree of agitation, pain, and hemodynamic changes during extubation, and the incidence and severity of abdominal pain and nausea and vomiting in the recovery and the total amount of analgesic requirement are evaluated during 24 hours after surgery. Intervention 2: Control group: They do not receive medication and the degree of agitation, pain, and hemodynamic changes during extubation, and the incidence and severity of abdominal pain and nausea and vomiting in the recovery and the total amount of analgesic requirement are evaluated during 24 hours after surgery. Yes - There is a plan to make this available What will be shared: All information used for this research can be shared after unidentified the identity of patients. Also, statistical information, information analysis, study method, findings and conclusions can be shared. When: Starting access after accepting by a valid scientific journal and publishing it To whom: For academic researchers and in the field of science Conditions: All researchers can use all published material and if all or part of this research is published by other people, the name and source of this research and its researchers should be mentioned. Where to obtain: Mohammad Reza Khajavi How to obtain: The applicant can request the type of files by email. khajavim@tums.ac.ir Comments:
public Mohammad Reza Khajavi
Sina Hospital Imam Khomeini
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1220 khajavim@tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Reza Khajavi
Sina Hospital Imam Khomeni st
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 8550 khajavim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with Body mass index grater than 40 20 years 55 years Both History of large prostate disease Glucome Drug addiction uncontrolled hyperthension R10.0 K 91.0 Acute abdomen Vomiting following gastrointestinal surgery Prevention Prevention Intervention group: 0.5 mg/kg of diphenhydramine is injected intravenously before anesthesia and the degree of agitation, pain, and hemodynamic changes during extubation, and the incidence and severity of abdominal pain and nausea and vomiting in the recovery and the total amount of analgesic requirement are evaluated during 24 hours after surgery. Control group: They do not receive medication and the degree of agitation, pain, and hemodynamic changes during extubation, and the incidence and severity of abdominal pain and nausea and vomiting in the recovery and the total amount of analgesic requirement are evaluated during 24 hours after surgery. Incidence and severity of abdominal pain. Timepoint: During extubation and 5, 15, 30 and 60 minutes after surgery. Method of measurement: Visual Analogue Scale. Severity of postoperative agitation. Timepoint: During extubation and 5, 15, 30 and 60 minutes after surgery. Method of measurement: Ramsy sedation Scale. Incidence of nausea and vomiting. Timepoint: In recovery room and ward. Method of measurement: The number of nausea and vomiting. Tehran University of Medical Sciences Approved 2019-03-04 Ethics committee of school of medicine, Tehran university of medical sciecences Sina hospital,Hasan Abad Sq-Emam khomeni st. Tehran Tehran Iran (Islamic Republic of)