Please select the eligibility criteria that correspond to the clinical trial below.
Title: Preoperative Dexamethasone Reduces Postoperative Pain, Nausea and Vomiting Following Mastectomy for Breast Cancer.
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.


Options:
A: Inclusion criteria

1. Male or female patients ≥ 18 years of age
2. Ability and willingness to give written informed consent
3. Patients undergoing elective surgery under general anaesthesia requiring at least one overnight stay in hospital for either:

   1. Hysterectomy (any surgical technique)
   2. Cholecystectomy (any surgical technique)
   3. Other elective surgery requiring overnight admission to hospital and scheduled to last at least 1 hour from induction of anaesthesia
4. Patients with at least 2 of the following risk factors for PONV:

   1. Past history of PONV and/or motion sickness
   2. Habitual non-smoking status
   3. Female sex
   4. Expected to receive opioid analgesia post-operatively
5. American Society of Anesthesiologists (ASA) risk score I-III
6. Adequate cardiac, hepatic and renal function

   * QTc interval \< 500 ms
   * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \< 5 x upper limit normal (ULN)
   * Bilirubin \< 3 x ULN
   * Creatinine \< 2 x ULN
7. Adequate haematological function

   * Haemoglobin ≥ 9 g/dL
   * White blood count ≥ 3.0 x 109/L
   * Platelet count ≥ 100 x 109/L
8. For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) between the date of screening and at least 48 hours after administration of study drug.

Exclusion Criteria

1. Patients undergoing outpatient/day case surgery
2. Patients undergoing surgery where the patient is expected to remain ventilated for a period after surgery
3. Patients undergoing intra-thoracic, transplant or central nervous system surgery
4. Patients receiving a local anaesthetic/regional neuraxial (intrathecal or epidural) block
5. Patients who are expected to need a naso- or oral-gastric tube in situ after surgery is completed
6. Patients receiving the active ingredient of APD421 for any indication within the last 2 weeks
7. Patients who are allergic to the active ingredient or any of the excipients of APD421
8. Patients with a pre-existing vestibular disorder or history of dizziness
9. Patients with pre-existing nausea or vomiting in the 24 hours before surgery
10. Patients treated with regular anti-emetic therapy including corticosteroids
11. Patients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin
12. Patients being treated with levodopa
13. Patients who are pregnant or breast feeding
14. Patients with a history of alcohol abuse
15. Patients with pre-existing, clinically significant cardiac arrhythmia
16. Patients diagnosed with Parkinson's disease
17. Patients who have received anti-cancer chemotherapy in the previous 4 weeks
18. Patients with a history of epilepsy
19. Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
20. Patients who have participated in a previous study within the last 28 days (French sites only: Patients who have participated in a previous study within the last 6 months, if required by national or local regulations)
B: 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.
C: Inclusion Criteria:

* Patients undergoing thyroid surgery for benign disease

Exclusion Criteria:

* Depression
* Chronic pain disorder
* Insulin dependent diabetes mellitus
* History of PONV
* Pregnancy
* Age \< 18 years
* Received antiemetic therapy within 48 hours
D: Inclusion Criteria:

* Elective (outpatient) and urgent (inpatient) cardiac surgery procedures requiring cardiopulmonary bypass, including:

  * Coronary artery bypass grafting (CABG)
  * Valve surgery (ie. repair and/or replacement)
  * CABG and valve surgery

Exclusion Criteria:

* Undergoing 'off-pump' CABG (not involving the cardiopulmonary bypass machine)
* With a contraindication to the study drug - including but not limited to congenital Long QT Syndrome, allergy to ondansetron, or a history of migraines
* Unable to understand the consent process, either due to language limitations or cognitive limitations if a translator or substitute decision maker is not available
* Receiving heart transplants, ventricular assist devices or on extra-corporeal membrane oxygenation (ECMO)
* Intubated for more than 12 hours post-operatively
* With a known history of PONV
* Sedated with dexmedatomine instead of propofol

Answer: B