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. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Li 2015‐2.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis and combination prophylaxis
Participants Baseline characteristics
Ondansetron (CS group)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 70

  • Received treatment (n): NA

  • Analysed (n): 70

  • Age (mean ± SD, median (IQR), median (range)): 48.74 ± 8.21

  • Weight (mean ± SD, median (IQR), median (range)): 63.26 ± 8.61

  • BMI (mean ± SD, median (IQR), median (range)): 24.50 ± 2.95

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): 100

  • History of PONV/motion sickness (%): 7.1

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 126.93

  • Use of perioperative opioids (if yes, which?): 15.58 µg sufentanil intraoperative, 110.00 mg tramadol postoperative

  • Type of surgery: modified radical mastectomy


Dexamethasone + ondansetron (DS group)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 70

  • Received treatment (n): NA

  • Analysed (n): 70

  • Age (mean ± SD, median (IQR), median (range)): 48.87 ± 7.48

  • Weight (mean ± SD, median (IQR), median (range)): 62.17 ± 8.18

  • BMI (mean ± SD, median (IQR), median (range)): 24.27 ± 3.11

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): 100

  • History of PONV/motion sickness (%): 7.1

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 112.60

  • Use of perioperative opioids (if yes, which?): 14.68 µg sufentanil intraoperative, 131.25 mg tramadol postoperative

  • Type of surgery: modified radical mastectomy


Included criteria: female, breast cancer, undergoing modified radical mastectomy with neoadjuvant chemotherapy, 18 to 60 years of age
Excluded criteria: neurological disease, severe cardiac disease, severe respiratory impairment, chronic disease of the digestive tract, long‐term preoperative use of analgesics, use of antiemetics, smoker
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no
Interventions Intervention characteristics
Ondansetron (CS group)
  • Dose: 8 mg (sevoflurane)

  • Time point of administration: placebo before anaesthetic induction, ondansetron 30 minutes before end of surgical procedure

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Dexamethasone + ondansetron (DS group)
  • Dose: dexamethasone 10 mg, ondansetron 8 mg (sevoflurane)

  • Time point of administration: dexamethasone before anaesthetic induction, ondansetron 30 minutes before end of surgical procedure

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA

Outcomes PONV (0 to 24 hours)
  • Outcome type: dichotomous outcome

Identification Sponsorship source: NA
Country: China
Setting: inpatient, single‐centre
Author's name: Zhi‐yi Fan
Institution: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Anesthesiology, Peking University Cancer Hospital Institute, Beijing, China
Email: 13911114196@163.com
Address: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Anesthesiology, Peking University Cancer Hospital Institute, Beijing 100142, China
Duration of study: NA
Language: Chinese (Google Translator)
Study's primary outcome: NA
Trial registry number: NA
Notes Four groups divided into 2 sub‐studies (2 different anaesthesia regimens: TIVA, inhalational anaesthesia): Li 2015‐1 and Li 2015‐2
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Judgement comment: quote: "randomized". No further information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Judgement comment: no statement
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgement comment: no missing outcome data
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Low risk Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no