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

Lee D 2009.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis, different routes of administration
Participants Baseline characteristics
Control

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 41 ± 8

  • Weight (mean ± SD, median (IQR), median (range)): 57 ± 5

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: TIVA

  • Duration of anaesthesia or surgery (in min; as mean or median): 110

  • Use of perioperative opioids (if yes, which?): 2.5 ng/mL to 3.5 ng/mL remifentanil intraoperative (target blood concentration, total amount of intraoperative remifentanil per group not reported), 2 patients received pethidine as rescue analgesia

  • Type of surgery: gynaecological laparoscopy


Ramosetron (IV group)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 41 ± 9

  • Weight (mean ± SD, median (IQR), median (range)): 58 ± 8

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: TIVA

  • Duration of anaesthesia or surgery (in min; as mean or median): 111

  • Use of perioperative opioids (if yes, which?): 2.5 ng/mL to 3.5 ng/mL remifentanil intraoperative (target blood concentration, total amount of intraoperative remifentanil per group not reported), 3 patients received pethidine as rescue analgesia

  • Type of surgery: gynaecological laparoscopy


Ramosetron (PO group)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 41 ± 8

  • Weight (mean ± SD, median (IQR), median (range)): 57 ± 8

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: TIVA

  • Duration of anaesthesia or surgery (in min; as mean or median): 105

  • Use of perioperative opioids (if yes, which?): 2.5 ng/mL to 3.5 ng/mL remifentanil intraoperative (target blood concentration, total amount of intraoperative remifentanil per group not reported), 2 patients received pethidine as rescue analgesia

  • Type of surgery: gynaecological laparoscopy


Included criteria: women, ASA I or II, 18 to 60 years of age, undergoing general anaesthesia for gynaecological laparoscopy
Excluded criteria: gastrointestinal disease, history of motion sickness, previous episode of PONV, menstruating, had taken an antiemetic medication within 24 hours before surgery
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
Control

  • Dose: saline, placebo

  • Time point of administration: IV immediately after induction of anaesthesia, PO 1 hour before surgery

  • Route of administration: IV/PO

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV, ondansetron 4 mg IV, dexamethasone 5 mg IV


Ramosetron (IV group)

  • Dose: 0.3 mg

  • Time point of administration: ramosetron immediately after induction of anaesthesia, placebo 1 hour before surgery

  • Route of administration: IV (ramosetron)/PO

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV, ondansetron 4 mg IV, dexamethasone 5 mg IV


Ramosetron (PO group)

  • Dose: 0.1 mg

  • Time point of administration: ramosetron 1 hour before surgery, placebo immediately after induction of anaesthesia

  • Route of administration: PO (ramosetron)/IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV, ondansetron 4 mg IV, dexamethasone 5 mg IV
Outcomes Headache (0 to 24 hours)

  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 24 hours' observation)

  • Outcome type: general notes on side effects
Identification Sponsorship source: this study was supported by Gil Medical Center, Incheon, Korea
Country: Korea
Setting: inpatient, single‐centre
Author's name: H.J. Kwak
Institution: Department of Anesthesiology and Pain Medicine, Gil Medical Center
Email: NA
Address: Gachon University of Medicine and Science, 1198 Guwol‐dong, Namdong‐gu, Incheon 405‐760, Korea
Duration of study: NA
Language: English
Study's primary outcome: incidence of complete response (no nausea, no retching, no vomiting)
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "effects on postoperative nausea 47 0.3 mg IV ramosetron (IV group), or 0.1 mg oral ramosetron (PO group), using a sealed envelope system. An independent researcher prepared..."
Quote: "patients were allocated randomly to one of three groups (n = 40 in each), to receive saline (control group)"
Judgement comment: insufficient information on random sequence generation (shuffling envelopes?)
Allocation concealment (selection bias) Unclear risk Quote: "...using a sealed envelope system. An independent researcher prepared the study solutions, which consisted of a drinking cup containing 10 ml saline and a syringe with 2 ml normal saline in the control group, a cup containing 10 ml saline and a syringe with 0.3 mg ramosetron in the IV group, and a cup containing completely dissolved ramosetron tablets in 10 ml saline and a syringe with 2 ml saline in the PO group. The oral test drug..."
Judgement comment: not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE)
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "the oral test drug was administered 1 hour before surgery and the IV test drug was injected immediately after the induction of anaesthesia by an investigator who was blinded to the study"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "all episodes of PONV (nausea, retching, and vomiting) during the periods 0 to 1 hour and 1 to 24 hours after anaesthesia were recorded by nursing staff who were unaware of which treatment each patient had been given"
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 Unclear risk Quote: "there were no differences in patient characteristics among the three groups (Table 2)"
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