Clinical trial · Interventional
Effect of Dexamethasone in Postoperative Symptoms After Mastectomy for Breast Cancer
Preoperative Dexamethasone Reduces Postoperative Pain, Nausea and Vomiting Following Mastectomy for Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Nausea | — | UNRESOLVED | — |
| Postoperative Pain | — | UNRESOLVED | — |
| Postoperative Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Homologated placebo. | Drug | — | UNRESOLVED |
| intravenous dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Dexamethasone group
- description
- This group of patients received intravenous dexamethasone (8 mg) 60 minutes before skin incision.
- interventionNames
- Drug: intravenous dexamethasone
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Patients of these group received homologated placebo 60 minutes before skin incision.
- interventionNames
- Drug: Homologated placebo.
Primary outcomes (1)
- measure
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGomez-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