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IRCT20210503051169N1 IRCT 2021-07-17 Esfahan University of Medical Sciences Evaluation of the relationship between end tidal carbon dioxide pressure and the incidence of severe nausea and vomiting after general anesthesia in laparoscopic cholecystectomy Evaluation of the relationship between end tidal carbon dioxide pressure and the incidence of severe nausea and vomiting after general anesthesia in laparoscopic cholecystectomy 2021-07-16 anticipated 88 Complete https://irct.ir/trial/56138 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random sequence (blocking) is generated by the help of Excel software and blocks of four are used to equalize the two groups so that the groups 1 and 2 of each person included in the study, can be determined randomly and equally. The blocks of four are separated from the samples and placed in the block randomly by the Excel software of group A or B. At the end, it is determined which letter represents the intervention group 1 and 2, Blinding description: The participant (patient) is not aware of which group they are in. The clinical caregiver adjusts the capnograph to one of two groups according to the randomization. Without knowing the grouping of people after the operation, the evaluator completes the outcome with a questionnaire without personal information. The questionnaires are given to the researcher in the form of A and B who do not know which is the first or second group. N/A Evaluation of the relationship between end tidal carbon dioxide pressure and the incidence of severe nausea and vomiting after general anesthesia in laparoscopic cholecystectomy. Intervention 1: Intervention group: The first group of people undergoing laparoscopic cholecystectomy, which is maintained by a capnograph of the end-tidal carbon dioxide level between 35-40 mm Hg. Intervention 2: Intervention group: The second group of people underwent laparoscopic cholecystectomy, which is maintained by a capnograph of the end-tidal carbon dioxide level between 40-45 mm Hg. Yes - There is a plan to make this available What will be shared: Only registered marks can be published without mentioning the names of the participants When: 6 months after printing the results To whom: It will be available only to researchers working in academic and scientific institutions Conditions: Written request by e-mail and approval of the Vice Chancellor for Research Where to obtain: By correspondence with the responsible author via email How to obtain: The applicant will be notified within one week of receiving the consent from the university,Maximum access takes 10 business days Comments:
public Dr.Khosro Naghibi
No. 17, Hezar Jarib St., Sepahan Alley, 6th St.
Esfahan Iran (Islamic Republic of) 8175675333 +98 31 3670 2548 khnaghibi@gmail.com Esfahan University of Medical Sciences scientific Dr.Khosro Naghibi
No. 17, Hezar Jarib St., Sepahan Alley, 6th St.
Esfahan Iran (Islamic Republic of) 8175675333 +98 31 3670 2548 khnaghibi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 88 candidates for laparoscopic cholecystectomy with ASA1,2 in the age group of 18-65 years 18 years 65 years Both Patients with ASA 3 and 4 Severe underlying disease such as heart failure, COPD, ESRD History of motion sickness and history of postoperative nausea and vomiting Allergy to anesthesia Treatment - Other Treatment - Other Intervention group: The first group of people undergoing laparoscopic cholecystectomy, which is maintained by a capnograph of the end-tidal carbon dioxide level between 35-40 mm Hg. Intervention group: The second group of people underwent laparoscopic cholecystectomy, which is maintained by a capnograph of the end-tidal carbon dioxide level between 40-45 mm Hg. Determining and comparing the frequency of postoperative nausea and vomiting in two groups with expiratory end carbon dioxide pressure of 40-40 and 40-45. Timepoint: Every 15 minutes in recovery 2, 4 and 6 hours after surgery. Method of measurement: Through a questionnaire. Determining and comparing the average dose of antiemetic drugs in two groups with expiratory carbon dioxide pressure of 40-40 and 45-40. Timepoint: At recovery time 2, 4 and 6 hours after surgery. Method of measurement: Through a questionnaire. Determining and comparing the average dose of opioids in two groups with expiratory end carbon dioxide pressure of 35-40 and 40-45. Timepoint: At recovery time 2, 4 and 6 hours after surgery. Method of measurement: Through a questionnaire. Determination and comparison of pain intensity during recovery in two groups with expiratory end of carbon dioxide pressure of 35-40 and 40-45. Timepoint: 2, 4 and 6 hours after surgery. Method of measurement: Based on VAS. Determining and comparing the average level of patient satisfaction in two groups with expiratory end carbon dioxide pressure of 40-40 and 45-40. Timepoint: In 6 hours after surgery. Method of measurement: Based on VAS. Determination and comparison of mean arterial blood pressure, oxygen saturation and heart rate in two groups with expiratory end carbon dioxide pressure of 40-40 and 45-40. Timepoint: Basically then every half hour during surgery and recovery. Method of measurement: Through a questionnaire. Determining and comparing the duration of anesthesia and the duration of recovery surgery (duration of extubation) in two groups with expiratory end carbon dioxide pressure of 35-40 and 40-45. Timepoint: end of surgery. Method of measurement: Through a questionnaire. Esfahan University of Medical Sciences Approved 2021-04-30 Ethics Committee of Isfahan University of Medical Sciences No.87, 3rdAlley, Golestan, Apadana St,1stAlley, Feiz square, Isfahan, Iran Esfahan Isfehan Iran (Islamic Republic of)