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

Graczyk 1997.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis, dose‐finding study
Participants Baseline characteristics
Placebo

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 157

  • Received treatment (n): 157

  • Analysed (n): 157

  • Age (mean ± SD, median (IQR), median (range)): 32 ± 7

  • Weight (mean ± SD, median (IQR), median (range)): 67 ± 14

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

  • ASA I/II/III/IV (n): 57/43/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 26/NA

  • Type of general anaesthesia: balanced anaesthesia (isoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 72

  • Use of perioperative opioids (if yes, which?): 167 µg intraoperative fentanyl

  • Type of surgery: outpatient laparoscopic surgery


Dolasetron (12.5 mg group)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 159

  • Received treatment (n): 159

  • Analysed (n): 159

  • Age (mean ± SD, median (IQR), median (range)): 32 ± 8

  • Weight (mean ± SD, median (IQR), median (range)): 69 ± 15

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

  • ASA I/II/III/IV (n): 58/42/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 21/NA

  • Type of general anaesthesia: balanced anaesthesia (isoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 66

  • Use of perioperative opioids (if yes, which?): 170 µg intraoperative fentanyl

  • Type of surgery: outpatient laparoscopic surgery


Dolasetron (25 mg group)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 157

  • Received treatment (n): 157

  • Analysed (n): 157

  • Age (mean ± SD, median (IQR), median (range)): 31 ± 6

  • Weight (mean ± SD, median (IQR), median (range)): 68 ± 14

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

  • ASA I/II/III/IV (n): 60/40/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 24/NA

  • Type of general anaesthesia: balanced anaesthesia (isoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 66

  • Use of perioperative opioids (if yes, which?): 169 µg intraoperative fentanyl

  • Type of surgery: outpatient laparoscopic surgery


Dolasetron (50 mg group)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 162

  • Received treatment (n): 162

  • Analysed (n): 162

  • Age (mean ± SD, median (IQR), median (range)): 31 ± 7

  • Weight (mean ± SD, median (IQR), median (range)): 69 ± 15

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

  • ASA I/II/III/IV (n): 63/37/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 24/NA

  • Type of general anaesthesia: balanced anaesthesia (isoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 66

  • Use of perioperative opioids (if yes, which?): 169 µg intraoperative fentanyl

  • Type of surgery: outpatient laparoscopic surgery


Included criteria: females scheduled for outpatient laparoscopic gynaecologic surgery with general anaesthesia, 18 years of age and older, not pregnant, ASA I or II
Excluded criteria: experienced preoperative nausea and/or vomiting within 24 hours of surgery or had taken any drug with antiemetic activity within that time; had taken an investigational drug within 30 days; significant cardiac conduction abnormalities; major organ dysfunction; exceeded ideal body weight by > 75%. No surgical procedures other than the primary gynaecologic procedure were allowed in patients who took part in the study
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV, perioperative opioids): no; (history of motion sickness, non‐smoker): unclear
Interventions Intervention characteristics
Placebo

  • Dose: saline 0.9%

  • Time point of administration: approximately 15 minutes before end of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): yes (not specified)


Dolasetron (12.5 mg group)

  • Dose: 12.5 mg

  • Time point of administration: approximately 15 minutes before end of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): yes (not specified)


Dolasetron (25 mg group)

  • Dose: 25 mg

  • Time point of administration: approximately 15 minutes before end of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): yes (not specified)


Dolasetron (50 mg group)

  • Dose: 50 mg

  • Time point of administration: approximately 15 minutes before end of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): yes (not specified)
Outcomes Complete response (no PONV) in 24 hours

  • Outcome type: dichotomous outcome


Headache (0 to 24 hours)

  • Outcome type: dichotomous outcome


Sedation/drowsiness (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: NA
Country: USA
Setting: outpatient, multi‐centre (25)
Author's name: Sarena G. Graczyk
Institution: Anesthesiologists of Columbia, PA, Columbia, South Carolina, tMagee‐Womens Hospital, Pittsburgh, Pennsylvania, USA
Email: NA
Address: Anaesthesiologists of Columbia, PA, Columbia, SC 29220, USA
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: complete response in 24 hours (no emetic episodes, no rescue medication)
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomized"
Judgement comment: 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 Quote: "double‐blind"
Judgement comment: insufficient information on blinding method
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding method ("double‐blind")
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "...intent‐to‐treat population), 612 (96%) had no major protocol deviations and were evaluable for efficacy"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a trial registry and no published study protocol available
Other bias Unclear risk Quote: "...and were evaluable for efficacy. No statistically significant differences among the treatment groups were observed at baseline for any patient characteristic (Table 1). Overall, the study population was 70% Caucasian and had a mean age of 32 yr. Approximately 25% of the patients had a previous history of PONV. The anesthesia procedures, including use of muscle relaxants, induction, and reversal drugs were statistically comparable among the treatment groups (Table 2). In addition, there were no differences among the groups in concomitant medications or use of postoperative analgesics that would be expected to influence efficacy or safety data. Adverse event data were summarized"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV, perioperative opioids): no; (history of motion sickness, non‐smoker): unclear