Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomised, Double-blind, Placebo-controlled, Phase II Study to Assess the Safety and Efficacy of Different Doses of Intravenous APD405 for the Prevention of Post-operative Nausea and Vomiting
Brief Summary: To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.


Options:
A: Inclusion Criteria:

* patients ≥ 18 \< 75 years
* ASA physical status I-II
* planned duration of anesthesia ≥ 60 minutes
* Apfel score ≥ 2-3
* elective (laparoscopic) surgery (abdominal, gynecological)
* women: with a highly effective contraception, defined as methods with a pearl index \< 1 (i.e. hormonal contraceptives, IUD)

Exclusion Criteria:

* history of hypersensitivity to any used drugs or additive components used for preparation and stabilization of the named drugs in this trial
* history or reasonable suspicion of malignant hyperthermia and/or degenerative neuromuscular disease, in the subject observed or blood relatives
* history of liver function disorders, leucocytosis and unclear fever after usage of halogenated anesthetics.
* any indisposition that may be aggravated by the use of the drugs investigated:
* liver and/or kidney function disorders
* severe acute or chronic infectious disease (i.e. viral, bacterial, fungal)
* elevated intracranial pressure
* history of gastrointestinal ulcer(s) or inflammatory bowel disease
* severe metabolic disorders
* hematoporphyria
* glaucoma
* hearing disorders
* any disease including air-filled closed cavities, such as pneumothorax, ileus
* pregnancy and lactation period
* subjects under the age of 18 years
* ambulatory surgery
* any disease that is associated with the requirement of a high oxygen yield and/or
* risk of high oxygen consumption:
* severe lung and/or airway disease
* coronary heart disease and/or seriously impaired cardiac function
* severe psychiatric disorder
B: Inclusion criteria:

* History of PONV and/or motion sickness.
* Have not smoked for the last 6 months.
* Having certain types of abdominal, breast or shoulder surgeries.

Exclusion criteria:

* Pregnant or breastfeeding.
* Taking certain medications.
* Have certain pre-existing medical conditions.
C: Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Written informed consent
* 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
* Patients with at least 2 risk factors for PONV, defined as 2 of the following:

  1. Past history of PONV and/or motion sickness
  2. Non-smoking status
  3. Female gender
  4. Planned opiate use for post-operative analgesia
* American Society of Anesthesiologists (ASA) risk score I-III (see Appendix 3)
* Adequate hepatic and renal function

  * Alanine aminotransferase (ALT) \<2.5 \* upper limit normal (ULN)
  * Aspartate aminotransferase (AST) \<2.5 \* ULN
  * Bilirubin \<1.5 \* ULN
  * Creatinine \<1.5 \* ULN
* Adequate haematological function

  * Haemoglobin ≥9.5 g/dL
  * White blood count 4.0-11.0 \* 10\^9/L
  * Platelet count ≥150 - 400 \* 10\^9/L
* Ability and willingness to give written informed consent

Exclusion Criteria:

* Patients undergoing outpatient/day case surgery
* Patients undergoing surgery where the patient is expected to remain ventilated for a period after surgery
* Patients undergoing intra-thoracic, transplant or central nervous system surgery
* Patients receiving a local anaesthetic/regional neuraxial (intrathecal or epidural) block
* Patients receiving monoamine oxidase inhibitor (MAOI) therapy currently or in the preceding 3 weeks
* Patients with a pre-existing vestibular disorder or history of dizziness
* Patients that are expected to need a naso- or oral-gastric tube in situ after surgery is completed
* Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
* Patients treated with regular anti-emetic therapy including corticosteroids
* Patients receiving CYP3A4 inducers or inhibitors within 7 days prior to study including but not limited to erythromycin, itraconazole, nefazodone, diltiazem, verapamil, rifampicin
* Patients with pre-existing nausea or vomiting 24 hours before surgery
* Patients who are breast feeding or pregnant
* Patients with a history of alcohol abuse
* Patients diagnosed with Parkinson's disease
* Patients who have received anti-cancer chemotherapy in the previous 4 weeks
* Patients with pre-existing clinically significant cardiac arrhythmia
* Patients with a history of epilepsy
* 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)
D: Inclusion Criteria:

* female gender, non-smoking and use of postoperative opioids undergoing laparocopic abdominal surgery

Exclusion criteria included laparoscopic abdominal surgey, allergy to one of the study drugs, opioid dependence, history of gastro-intestinal disease or Parkinson's disease, history of previous PONV and motion sickness, contra-indication for epidural block (previous back surgery, bleeding diathesis or neurological dysfunction), anti-emetic medication within 24 h before surgery, inability to use the PCEA device or comprehend the visual analogue scales (VAS) for pain and nausea assessment, or unwillingness to be enrolled in the study.

Answer: C