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

Park 2011.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Ondansetron

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 45

  • Received treatment (n): 45

  • Analysed (n): 45

  • Age (mean ± SD, median (IQR), median (range)): 42.8 ± 7.3

  • Weight (mean ± SD, median (IQR), median (range)): 55.3 ± 7.3

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

  • ASA I/II/III/IV (n): 37/8/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 95.6

  • History of PONV/motion sickness (%): 42.2

  • Type of general anaesthesia: inhalational (N₂O, sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 137.1

  • Use of perioperative opioids (if yes, which?): PCA fentanyl 4 µg bolus with 16 µg/h background infusion for postoperative pain

  • Type of surgery: laparoscopic ovarian cystectomy 18, laparoscopic hysterectomy 27


Palonosetron

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 45

  • Received treatment (n): 45

  • Analysed (n): 45

  • Age (mean ± SD, median (IQR), median (range)): 42.4 ± 10.0

  • Weight (mean ± SD, median (IQR), median (range)): 56.9 ± 7.8

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

  • ASA I/II/III/IV (n): 40/5/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 86.7

  • History of PONV/motion sickness (%): 44.4

  • Type of general anaesthesia: inhalational (N₂O, sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 130.4

  • Use of perioperative opioids (if yes, which?): PCA fentanyl 4 µg bolus with 16 µg/h background infusion for postoperative pain

  • Type of surgery: laparoscopic ovarian cystectomy 17, laparoscopic hysterectomy 28


Included criteria: at least 21 years old, ASA I or II, scheduled to undergo elective laparoscopic gynaecological surgery of at least 1 hour duration at Incheon St Mary’s Hospital, Incheon, female, used opioids to control postoperative pain, had at least 2 risk factors for PONV
Excluded criteria: received antiemetics, steroids or psychoactive medications within 24 hours of study initiation, vomiting or retching in 24 hours before surgery, had received cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry, ongoing vomiting from gastrointestinal disease
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness): no; (perioperative opioids): unclear
Interventions Intervention characteristics
Ondansetron

  • Dose: 8 mg

  • Time point of administration: immediately before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg iv, 2nd line ondansetron 4 mg iv; 15.6%


Palonosetron

  • Dose: 0.075 mg

  • Time point of administration: immediately before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg iv, 2nd line ondansetron 4 mg iv; 17.8%
Outcomes Vomiting (0 to 24 hours)

  • Outcome type: dichotomous outcome


Vomiting (0 to 2 hours)

  • Outcome type: dichotomous outcome


Vomiting (6 to 24 hours)

  • Outcome type: dichotomous outcome


PONV (0 to 24 hours)

  • Outcome type: dichotomous outcome


Complete response (no PONV) in 24 hours

  • Outcome type: dichotomous outcome


Headache (0 to 24 hours)

  • Outcome type: dichotomous outcome


Constipation (0 to 24 hours)

  • Outcome type: dichotomous outcome
Identification Sponsorship source: NA
Country: Korea
Setting: inpatient, single‐centre
Author's name: Eun Jung Cho
Institution: Incheon St Mary's Hospital, Catholic University of Korea
Email: gkjw2000@catholic.ac.kr
Address: Department of Anaeshtesiology and Pain Medicine, Incheon St Mary's Hospital, College of Medicine, The Catholic University of Korea, 665‐8 Bupyeong 6 dong, Pupyeonggu, Incheon 403‐720, Republic of Korea
Duration of study: June to September 2010
Language: English
Study's primary outcome: incidence of PONV
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "assigned by computer‐ generated random numbers"
Allocation concealment (selection bias) Unclear risk Quote: "placed them in numbered, sealed envelopes"
Judgement comment: not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE)
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "trained nurses who did not participate in the study prepared the drugs according to manufacturers’ instructions"
Judgement comment: no statement whether drugs were unlabelled and were undistinguishable from one another
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement on blinding of outcome assessors
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "in total, 90 patients were recruited, all of whom completed the study"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Unclear risk Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness): no; (perioperative opioids): unclear