Protocol title: Role of low dose droperidol in postoperative vomiting Purpose: Evaluate the efficacy of droperidol to postoperative nausea and vomiting when administrated at the introduction to anesthesia, prior to surgery Design: Prospective, randomized, placebo-controlled study Patient Population: Male or female subjects 18 years of age or older who are scheduled for laparoscopic cholecystectomy No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to enroll Duration of Treatment: Prior operation Duration of Follow-up: Follow-up will be performed for 24 hours postoperatively Endpoints: To evaluate the effectiveness of low dose droperidol when administered Prior surgery
In this prospective, randomized, placebo-controlled study, the researchers determined whether 0.625 mg (1/2 amp) IV droperidol given at the initiation of general anesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in laparoscopic cholecystectomy population. One hundred patients receiving general anesthesia for laparoscopic cholecystectomy received droperidol 0.625 mg (1/2 amp) mg or placebo prior operation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
100
0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy
Saline solution administrated i.v 30 min prior surgery
3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, Macedonia, Greece
3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, Greece
Vomiting episodes
Time frame: 24 hours
Light nausea
Time frame: 24 hours
Control of nausea
Time frame: 24 hours
Anti-vomiting treatment
Time frame: 24 hours
Adverse events
Time frame: 24 hours
Modification of electrocardiograph
Time frame: 24 hours
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