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

Song 2017.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Ramosetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 150

  • Received treatment (n): 150

  • Analysed (n): 150

  • Age (mean ± SD, median (IQR), median (range)): NA (reported for different genotypes, no difference between groups)

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

  • BMI (mean ± SD, median (IQR), median (range)): NA (reported for different genotypes, no difference between groups)

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): NA (reported for different genotypes, no difference between groups)

  • Non‐smoker (%): NA (reported for different genotypes, no difference between groups)

  • History of PONV/motion sickness (%): NA (reported for different genotypes, no difference between groups)

  • Type of general anaesthesia: balanced anaesthesia (sevoflurane, remifentanil)

  • Duration of anaesthesia or surgery (in min; as mean or median): NA (reported for different genotypes, no difference between groups)

  • Use of perioperative opioids (if yes, which?): remifentanil, fentanyl via PCA (reported for different genotypes, no difference between groups)

  • Type of surgery: spinal surgery


Palonosetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 150

  • Received treatment (n): 150

  • Analysed (n): 146

  • Age (mean ± SD, median (IQR), median (range)): NA (reported for different genotypes, no difference between groups)

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

  • BMI (mean ± SD, median (IQR), median (range)): NA (reported for different genotypes, no difference between groups)

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): NA (reported for different genotypes, no difference between groups)

  • Non‐smoker (%): NA (reported for different genotypes, no difference between groups)

  • History of PONV/motion sickness (%): NA (reported for different genotypes, no difference between groups)

  • Type of general anaesthesia: balanced anaesthesia (sevoflurane, remifentanil)

  • Duration of anaesthesia or surgery (in min; as mean or median): NA (reported for different genotypes, no difference between groups)

  • Use of perioperative opioids (if yes, which?): remifentanil, fentanyl via PCA, (reported for different genotypes, no difference between groups)

  • Type of surgery: spinal surgery


Included criteria: 20 to 85 years of age, ASA I or II, undergoing spinal surgery (type of surgery included cervical laminoplasty, cervical anterior interbody fusion, lumbar laminectomy, posterior lumbar interbody fusion, and benign spinal cord tumour removal)
Excluded criteria: administration of an antiemetic within 24 hours before surgery, regular administration of opioids or corticosteroids, history of psychiatric disorder, active drug or alcohol abuse, gastrointestinal motility disorder, severe hepatic or renal disease, uncontrolled diabetes, pregnancy, malignancy, body mass index > 35 kg/m², postoperative admission to an intensive care unit
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
Ramosetron
  • Dose: 0.3 mg

  • Time point of administration: 20 minutes before end of surgery and 24 hours after surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): (19%) metoclopramide 10 mg


Palonosetron
  • Dose: 0.075 mg

  • Time point of administration: 20 minutes before end of surgery and 24 hours after surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): (26%) metoclopramide 10 mg

Outcomes Vomiting (0 to 6 hours)
  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 48 hours' observation)
  • Outcome type: general notes on side effects

Identification Sponsorship source: supported solely by departmental sources
Country: Korea
Setting: inpatient, single‐centre
Author's name: Young Lan Kwak
Institution: Department of Anesthesiology and Pain Medicine; and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
Email: ylkwak@yuhs.ac
Address: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research, Institute Yonsei University College of Medicine, 50 Yonsei‐ro, Seodaemun‐gu, Seoul 120‐752, Republic of Korea
Duration of study: NA
Language: English
Study's primary outcome: incidence of PONV during postoperative 48 hours for patients with ABCB1 TT and non‐TT genotype who received prophylactic ramosetron or palonosetron
Trial registry number: NCT02480088
Notes Repetitive dose of study drug after 24 hours
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were assigned to either the ramosetron or the palonosetron group according to a computer‐generated randomization list"
Allocation concealment (selection bias) Low risk Quote: "sequentially numbered opaque envelopes containing the group assignment were opened on the day of operation by a nurse who was not involved in patients’ management, and the nurse prepared the study drugs as assigned"
Judgement comment: SNOSE
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "...by a nurse who was not involved in patients’ management, and the nurse prepared the study drugs as assigned. The group assignment was blinded to both patients and investigators until the end of the study"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Judgement comment: quote: "the group assignment was blinded to both patients and investigators until the end of the study"
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "four patients in the palonosetron group were excluded because they were transferred to the intensive care unit after surgery (Fig. 1)"
Selective reporting (reporting bias) Unclear risk Judgement comment: NCT02480088 (retrospective registration)
Other bias Low risk Quote: "patient characteristics and operative data were comparable between the ramosetron and palonosetron groups, as well as between the non‐TT and TT for each group (Table 1)"
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