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IRCT20211013052762N1 IRCT 2021-11-18 Oroumia University of Medical Sciences comparing the effect of the application of pulmonary recruitment maneuver and supplemental oxygen therapy and their combination on shoulder pain and nausea and vomiting in patients undergoing laparoscopic cholecystectomy in the Shahid Arefian Hospital of Urmia city in 2021 Comparing the effect of the application of pulmonary recruitment maneuver and supplemental oxygen therapy and their combination on shoulder pain and nausea and vomiting in patients undergoing laparoscopic cholecystectomy in the Shahid Arefian Hospital of Urmia 2021-12-01 anticipated 100 Complete https://irct.ir/trial/59833 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, random allocation with a ratio of 1: 1: 1: 1 will be divided into four groups: pulmonary record, complementary oxygen therapy, combined method (pulmonary record and complementary oxygen therapy), and control using the secure envelope method. In this way, inside the envelopes, closed sheets will contain all four approaches with equal proportions and sample volumes. Before starting the interventions, a person not related to the research will randomly select one of the sheets. Moreover, the patient will subsequently be assigned to that group. Due to the nature of the study, the patient will not know which group will be assigned. Also, when analyzing the data, the groups will be provided to the statistical analyst anonymously with the English letters A, B, C, and D; Therefore, the study will be double-blind, Blinding description: The present study will be a double-blind, four-group, 2 * 2 factorial design clinical trial. N/A Cholelithiasis. Intervention 1: The first intervention group: in the combined method group (group A), a combination of two interventions of pulmonary recruitment maneuver combined with complementary oxygen therapy. Intervention 2: Intervention group 2: In pulmonary recruiting group (group B), the air pressure relief valve will be closed on the ventilator to fill the bag. Then five manual breaths will be given for each breath for 5 seconds. Intervention 3: Intervention group: Intervention group 3: For the supplemental oxygen therapy group (group C), routine surgical interventions will be performed and from the moment the patient enters the ward until 6 hours later, 2 to 4 liters of oxygen per minute will be prescribed for the patient. Intervention 4: Control group: In the control group (group D), the usual procedure will be performed by applying gentle abdominal pressure to remove CO2 through the port at the end of surgery. 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 Its release schedule is not yet known.
public Yaser Moradi
Resalat Boulevard, Emergency Alley
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 yasermoradi1045@yahoo.com Oroumia University of Medical Sciences scientific Yaser Moradi
Resalat Boulevard, Emergency Alley
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 yasermoradi1045@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients with anesthesia class one and two and can communicate verbally Patients in the age range of 35 to 55 years Candidate for elective laparoscopic cholecystectomy with general anesthesia No chronic obstructive pulmonary, renal, hepatic, cardiac, gastrointestinal and cerebral diseases No history of diseases causing nausea and vomiting No electrolyte disturbance No motion sickness No smoking 35 years 55 years Both Patients whose intra-abdominal pressure is more than 14 mm Hg during surgery. No concomitant non-laparoscopic surgery Receive antiemetic drugs before and after surgery Peritoneal cavity infection Hemoperitoneum and multiple adhesions in the peritoneum and peripheral when surgical procedure changed to laparotomy. Having a history of laparotomy Having any underlying disease Smoking K80.0 Calculus of gallbladder with acute cholecystitis Treatment - Other Treatment - Other Treatment - Other Treatment - Other The first intervention group: in the combined method group (group A), a combination of two interventions of pulmonary recruitment maneuver combined with complementary oxygen therapy. Intervention group 2: In pulmonary recruiting group (group B), the air pressure relief valve will be closed on the ventilator to fill the bag. Then five manual breaths will be given for each breath for 5 seconds. Intervention group: Intervention group 3: For the supplemental oxygen therapy group (group C), routine surgical interventions will be performed and from the moment the patient enters the ward until 6 hours later, 2 to 4 liters of oxygen per minute will be prescribed for the patient. Control group: In the control group (group D), the usual procedure will be performed by applying gentle abdominal pressure to remove CO2 through the port at the end of surgery. Shoulder pain. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Nausea and Vomiting. Timepoint: 12 and 24 hours after surgery. Method of measurement: Rhodes scale. Oroumia University of Medical Sciences Approved 2021-09-29 Urmia university of medical sciences Resalat Boulevard, Emergency Alley Urmia West Azarbaijan Iran (Islamic Republic of)