Effect of Dexamethasone in Postoperative Symptoms After Mastectomy for Breast Cancer

NCT01116713 | Completed Phase 3 DMC

• 1 other identifier: Dxt-2010-breast cancer
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Mastectomy; Breast cancer; Postoperative pain; Postoperative nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  24 hours

Secondary Outcomes (3)

• 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).

  24 hours

• Total dose of backup analgesic and antiemetic medication administrated to each patient

  24 hours

• Morbidity and mortality after mastectomy

  30 days

Study Arms (2)

Dexamethasone group

ACTIVE COMPARATOR

This group of patients received intravenous dexamethasone (8 mg) 60 minutes before skin incision.

Drug: intravenous dexamethasone

Placebo group

PLACEBO COMPARATOR

Patients of these group received homologated placebo 60 minutes before skin incision.

Drug: Homologated placebo.

Interventions

intravenous dexamethasone DRUG

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

Also known as: no other intervention

Dexamethasone group

Homologated placebo. DRUG

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

Also known as: no other intervention

Placebo group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (2)

Breast Clinic. Oncologic Institute of Jalisco

Guadalajara, Jalisco, 44340, Mexico

Location

Research Unit in Clinical Epidemiology, Specialties Hospital. Mexican Institute of Sociaql Security

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (1)

• Gomez-Hernandez J, Orozco-Alatorre AL, Dominguez-Contreras M, Oceguera-Villanueva A, Gomez-Romo S, Alvarez Villasenor AS, Fuentes-Orozco C, Gonzalez-Ojeda A. Preoperative dexamethasone reduces postoperative pain, nausea and vomiting following mastectomy for breast cancer. BMC Cancer. 2010 Dec 23;10:692. doi: 10.1186/1471-2407-10-692.

  PMID: 21182781 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Breast Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alejandro Gonzalez-Ojeda, M.D., Ph.D.

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: June 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 5, 2010

Record last verified: 2010-05

Locations

ME (2)