-
Study aim
-
Evaluation the level of Nausea and Vomitting after Laparoscopic Cholecystectomy with using Intrapritoneal injection of Dexamethasone in compare to its Intravenous form
-
Design
-
Randomized, phase 3 clinical trial with two parallel groups, with control group, double- blind, postoperative care, on 80 patients.
-
Settings and conduct
-
This study is a double-blind randomized controlled clinical trial in which the target population will be patients who are candidates for laparoscopic cholecystectomy at Al-Zahra Hospital in Isfahan. Patients are divided into three groups by simple random allocation. After being placed on the operating table and connecting the monitor to the patient, each group is injected with allocated drug. The patient's vital signs and hemodynamic status are controlled and recorded before, during, and after the operation. The intervention groups are coded, so the injector, clinical caregiver, surgeon, and patient are unaware of the injected intervention and are blind.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: all patients aged 18 to 65 years who are candidates for laparoscopic cholecystectomy in ASA class I and II anesthesia . Exclusion criteria: Preoperative nausea and vomiting and pregnancy, allergic to corticosteroids and use it before surgery.
-
Intervention groups
-
After removing the last clamp,Group A receives 2cc intrapritoneal Normal saline and 8mg intravenous Dexamethasone.Group B,receives 2cc intravenous Normal saline and 8mg intrapritoneal Dexamethasone.Group C receives 2cc intravenous Normal saline and 2cc intrapritoneal Normal saline.
-
Main outcome variables
-
Nausea and Vomitting, Pain, Blood pressure, Heart rate, Blood oxygen saturation and patients satisfaction.