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Effect of Dexamethasone in Postoperative Symptoms After Mastectomy for Breast Cancer

NCT01116713 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2010-05-05

No results posted yet for this study

Summary

Postoperative pain, nausea and vomiting (PONV) are the most common complications after anesthesia and surgery. Women undergoing mastectomy with axillary dissection are at a particularly high risk for the development of PONV and an incidence of 60-80% in patients receiving no antiemetic has been reported. Emetic episodes predispose to aspiration of gastric contents, wound dehiscence, psychological distress, and delayed recovery and discharge times. These justify the use of prophylactic antiemetics in women scheduled for mastectomy. Most of the currently used antiemetics, including antihistamines, butyrophenones and dopamine receptor antagonists have been reported to cause occasional undesirable adverse effects, such as excessive sedation, hypotension, dry mouth, dysphoria, hallucinations and extrapyramidal signs. Antiserotonins (e.g., ondansetron) are available for the prevention and treatment of PONV in patients undergoing various types of surgery \[4\]. However, the use of prophylactic antiemetic therapy with antiserotonins has been criticized for being too expensive.

Dexamethasone was first reported to be an effective antiemetic regimen in patients receiving cancer chemotherapy.

The purpose of this study was to evaluate the efficacy of dexamethasone treatment for reducing pain and PONV as well as analgesic and antiemetic requirements in women undergoing general anesthesia for mastectomy with axillary lymph node dissection.

Conditions

  • Postoperative Pain
  • Postoperative Nausea
  • Postoperative Vomiting

Interventions

DRUG

intravenous dexamethasone

One dose of intravenous dexamethasone (8 mg) 60 minutes before skin incision.

DRUG

Homologated placebo.

Patients of the control group received homologated placebo 60 minutes before skin incision

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Principal Investigators

  • Alejandro Gonzalez-Ojeda, M.D., Ph.D. · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • Mexico

Study Locations

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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 NCT01116713 on ClinicalTrials.gov