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

Lee WS 2015.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis
Participants Baseline characteristics
Palonosetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 35

  • Received treatment (n): 35

  • Analysed (n): 35

  • Age (mean ± SD, median (IQR), median (range)): 51.5 ± 16.3

  • Weight (mean ± SD, median (IQR), median (range)): 60.1 ± 4.9

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

  • ASA I/II/III/IV (n): 23/12/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 0

  • Type of general anaesthesia: combined anaesthesia (propofol + remifentanil + sevoflurane + N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 128.1

  • Use of perioperative opioids (if yes, which?): induction and maintenance of anaesthesia with remifentanil

  • Type of surgery: laparoscopic hysterectomy


Granisetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 35

  • Received treatment (n): 35

  • Analysed (n): 35

  • Age (mean ± SD, median (IQR), median (range)): 52.5 ± 15.7

  • Weight (mean ± SD, median (IQR), median (range)): 59.3 ± 5.1

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

  • ASA I/II/III/IV (n): 24/11/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 0

  • Type of general anaesthesia: combined anaesthesia (propofol + remifentanil + sevoflurane + N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 123.5

  • Use of perioperative opioids (if yes, which?): induction and maintenance of anaesthesia with remifentanil

  • Type of surgery: laparoscopic hysterectomy


Ramosetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 35

  • Received treatment (n): 35

  • Analysed (n): 35

  • Age (mean ± SD, median (IQR), median (range)): 48.2 ± 12.1

  • Weight (mean ± SD, median (IQR), median (range)): 56.3 ± 4.3

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

  • ASA I/II/III/IV (n): 26/9/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 0

  • Type of general anaesthesia: combined anaesthesia (propofol + remifentanil + sevoflurane + N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 120.1

  • Use of perioperative opioids (if yes, which?): induction and maintenance of anaesthesia with remifentanil

  • Type of surgery: laparoscopic hysterectomy


Included criteria: healthy female undergoing laparoscopic hysterectomy under general anaesthesia
Excluded criteria: allergy to any of the experimental drugs, opioid dependence, history of PONV and motion sickness, use of antiemetic medication within 24 hours before surgery, pregnancy, inability to use patient‐controlled analgesia (PCA) IV device or to comprehend 10 cm visual analogue scale (VAS; 0, none; 10, maximum) for pain and nausea assessment, unwillingness to be enrolled in the study
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness): no; (non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Palonosetron
  • Dose: 0.075 mg

  • Time point of administration: at the end of surgery, before extubation

  • Route of administration: IV

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


Granisetron
  • Dose: 3 mg

  • Time point of administration: at the end of surgery, before extubation

  • Route of administration: IV

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


Ramosetron
  • Dose: 0.3 mg

  • Time point of administration: at the end of surgery, before extubation

  • Route of administration: IV

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

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


Vomiting (6 to 24 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: CKDpharm
Country: South Korea
Setting: inpatient, single‐centre
Author's name: Won‐Suk Lee
Institution: Department of Anesthesiology Surgery, Gil Medical Center, Gachon University, School of Medicine, Incheon, South Korea
Email: gachonlws@gmail.com
Address: Department of Anesthesiology Surgery, Gil Medical Center, Gachon University, School of Medicine, Incheon, South Korea
Duration of study: November 2011 to June 2013
Language: English
Study's primary outcome: incidence of complete responders during the study period
Trial registry number: NCT01752374
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "using a random number table"
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "this investigator‐initiated, prospective, non‐blinded, randomized controlled trial"
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "the incidence of nausea and vomiting was recorded during the assessment periods by ward nursing staff not blinded to the treatment drugs"
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "all patients completed the study"
Selective reporting (reporting bias) Unclear risk Judgement comment: NCT01752374 (retrospective registration)
Other bias Unclear risk Quote: "the groups were comparable with respect to age, weight, duration of surgery, and ASA score"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness): no; (non‐smoker, perioperative opioids): unclear