Dexamethasone Improves Postoperative Symptoms After Laparoscopic Cholecystectomy

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Dexamethasone has been reported to reduce postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy (LC). However, its effects on other surgical outcomes such as pain and fatigue have been unclear. We evaluated the efficacy of preoperative dexamethasone in ameliorating postoperative symptoms after LC.

Methods: Prospective, double-blind, placebo-controlled study, 210 patients scheduled for elective LC were analyzed after randomization to intravenous dexamethasone (8 mg) or to a placebo. All patients underwent standardized procedures for general anesthesia and surgery. Episodes of PONV and pain and fatigue scores were recorded on a visual analogue scale. Analgesic and antiemetic requirements were also recorded.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Mexicano del Seguro Social
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria: Adult patients (ASA I and II) with symptomatic cholelithiasis.

Exclusion Criteria:Patients of American Society of Anesthesiologists (ASA) classes III and IV were excluded. Further exclusion criteria were age more than 80 years; pregnancy; treatment with steroids; severe diabetes mellitus (HbA1c > 8%); use of opioids, sedatives or any kind of analgesics less than one week before LC; a history of alcohol or drug abuse; preoperative diagnosis of acute cholecystitis, acute pancreatitis, choledocolithiasis, gallbladder carcinoma and/or conversion of the LC to an open procedure.