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Dexamethasone Improves Postoperative Symptoms After Laparoscopic Cholecystectomy

NCT01030614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2009-12-11

No results posted yet for this study

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.

Conditions

  • Postoperative Nausea and Vomiting
  • Postoperative Pain
  • Postoperative Fatigue

Interventions

DRUG

Dexamethasone

intravenous dexamethasone 8 mgr before laparoscopic cholecystectomy or intravenous placebo before laparoscopic cholecystectomy

DRUG

placebo

One hundred five patients were randomized to receive intravenous placebo before laparoscopic cholecystectomy

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Principal Investigators

  • Alejandro Gonzalez-Ojeda, M.D., Ph.D. · Full-time Surgical Researcher and Professor of Surgery. Surgical Research Unit. Specialties Hospital. Mexican Institute of Social Security. Guadalajara, Jal. Mexico

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-08-31
Completion
2008-12-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01030614 on ClinicalTrials.gov