Effect of Dexamethasone in Postoperative Symptoms After Mastectomy for Breast Cancer (dxt2010brca)

This study has been completed.
Sponsor:
Information provided by:
Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT01116713
First received: May 4, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Postoperative Nausea
Postoperative Vomiting
Drug: intravenous dexamethasone
Drug: Homologated placebo.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preoperative Dexamethasone Reduces Postoperative Pain, Nausea and Vomiting Following Mastectomy for Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Instituto Mexicano del Seguro Social:

Primary Outcome Measures:
  • Pain was assessed immediately on return to the recovery room and at 6, 12 and 24 h after the operation using a visual analogue scale (VAS; 0 = no pain to 10 = most severe pain). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The pain intensity was recorded by a member of the team, blinded to the interventional manouver. A visual analogue scale for pain was used. The patient stablished the pain intensity and the researcher captured el number level. The information was obtained in the recovery room after the patient was monitorized and blood pressure and oxigen blood content values were normal. The information was obtained after 6, 12 and 24 hours after the surgical procedure.


Secondary Outcome Measures:
  • The incidence of nausea and vomiting was recorded immediately on return to the recovery room and at 6, 12 and 24 h after the operation, using a three point ordinal scale (0 = none, 1 = nausea, 2 = retching, 3 = vomiting). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The presence of nausea and vomiting was recorded by a member of the team, blinded to the interventional manouver. A visual analogue scale for pain was used. The information was classified as asymptomatic (0), presence of nausea (1), retching (2) and vomiting (3) . The information was obtained in the recovery room after the patient was monitorized and blood pressure and oxigen blood content values were normal. The information was obtained after 6, 12 and 24 hours after the surgical procedure.

  • Total dose of backup analgesic and antiemetic medication administrated to each patient [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Total dose of backup analgesic and antiemetic medication were recorded during the first 24 hours after the surgical procedure.

  • Morbidity and mortality after mastectomy [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Evaluation of any surgical or medical complication after surgery as well as mortalitiy 30 days after surgical treatment.


Enrollment: 70
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone group
This group of patients received intravenous dexamethasone (8 mg) 60 minutes before skin incision.
Drug: intravenous dexamethasone
One dose of intravenous dexamethasone (8 mg) 60 minutes before skin incision.
Other Name: no other intervention
Placebo Comparator: Placebo group
Patients of these group received homologated placebo 60 minutes before skin incision.
Drug: Homologated placebo.
Patients of the control group received homologated placebo 60 minutes before skin incision
Other Name: no other intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists classes I-II female patients with breast cancer scheduled for surgical treatment; mastectomy plus axillary node dissection.

Exclusion Criteria:

  • American Society of Anesthesiologists classes III and IV.
  • Age more than 80 years; pregnancy; active menstruation; treatment with steroids; severe diabetes mellitus (serum HbA1c > 8%); use of opioids, sedatives or any kind of analgesics less than one week before mastectomy, or a history of alcohol or drug abuse.
  • Patients with any history of motion sickness and or previous postoperative nausea and vomiting after any surgical procedure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116713

Locations
Mexico
Breast Clinic. Oncologic Institute of Jalisco
Guadalajara, Jalisco, Mexico, 44340
Research Unit in Clinical Epidemiology, Specialties Hospital. Mexican Institute of Sociaql Security
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
Study Director: Alejandro Gonzalez-Ojeda, M.D., Ph.D. Instituto Mexicano del Seguro Social
  More Information

No publications provided by Instituto Mexicano del Seguro Social

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alejandro Gonzalez-Ojeda, Mexican Institute of Social Security
ClinicalTrials.gov Identifier: NCT01116713     History of Changes
Other Study ID Numbers: Dxt-2010-breast cancer
Study First Received: May 4, 2010
Last Updated: May 4, 2010
Health Authority: Mexico: Ministry of Health

Keywords provided by Instituto Mexicano del Seguro Social:
Mastectomy
Breast cancer
Postoperative pain
Postoperative nausea and vomiting

Additional relevant MeSH terms:
Breast Neoplasms
Nausea
Pain, Postoperative
Vomiting
Breast Diseases
Neoplasms
Neoplasms by Site
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Skin Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 29, 2014