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

Adducci 2002.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 5 groups, monoprophylaxis and combination prophylaxis
Participants Baseline characteristics
Ondansetron

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 34

  • Received treatment (n): 34

  • Analysed (n): 34

  • Age (mean ± SD, median (IQR), median (range)): 48 (44 to 53)

  • Weight (mean ± SD, median (IQR), median (range)): 66 (62 to 71)

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

  • ASA I/II/III/IV (n): 24/10/0/0

  • Gender (female in %): 67.65

  • Non‐smoker (%): NA

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

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

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

  • Use of perioperative opioids (if yes, which?): 231 µg fentanyl

  • Type of surgery: laparoscopic cholecystectomy


Metoclopramide

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 38

  • Received treatment (n): 38

  • Analysed (n): 38

  • Age (mean ± SD, median (IQR), median (range)): 51 (47 to 55)

  • Weight (mean ± SD, median (IQR), median (range)): 70 (66 to 74)

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

  • ASA I/II/III/IV (n): 25/13/0/0

  • Gender (female in %): 71.05

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 83

  • Use of perioperative opioids (if yes, which?): 246 µg fentanyl

  • Type of surgery: laparoscopic cholecystectomy


Ondansetron + dexamethasone

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 35

  • Received treatment (n): 35

  • Analysed (n): 35

  • Age (mean ± SD, median (IQR), median (range)): 45 (40 to 49)

  • Weight (mean ± SD, median (IQR), median (range)): 66 (62 to 70)

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

  • ASA I/II/III/IV (n): 24/11/0/0

  • Gender (female in %): 77.14

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 80

  • Use of perioperative opioids (if yes, which?): 225 µg fentanyl

  • Type of surgery: laparoscopic cholecystectomy


Metoclopramide + dexamethasone

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 37

  • Received treatment (n): 37

  • Analysed (n): 37

  • Age (mean ± SD, median (IQR), median (range)): 50 (45 to 55)

  • Weight (mean ± SD, median (IQR), median (range)): 74 (69 to 80)

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

  • ASA I/II/III/IV (n): 27/10/0/0

  • Gender (female in %): 64.86

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 80

  • Use of perioperative opioids (if yes, which?): 244 µg fentanyl

  • Type of surgery: laparoscopic cholecystectomy


Placebo

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 36

  • Received treatment (n): 36

  • Analysed (n): 36

  • Age (mean ± SD, median (IQR), median (range)): 49 (44 to 53)

  • Weight (mean ± SD, median (IQR), median (range)): 71 (67 to 74)

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

  • ASA I/II/III/IV (n): 28/8/0/0

  • Gender (female in %): 72.22

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 88

  • Use of perioperative opioids (if yes, which?): 240 µg fentanyl

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: 18 to 75 years of age, ASA physical status I and II, undergoing general anaesthesia for laparoscopic cholecystectomy
Excluded criteria: history of gastrointestinal or neuromuscular disease, known narcotic use or alcohol abuse, patients under 18 or over 75 years of age, patients with nausea and vomiting within 72 hours of surgery or who had received antiemetic therapy
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear
Interventions Intervention characteristics
Ondansetron

  • Dose: 8 mg

  • Time point of administration: 2 minutes before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Metoclopramide

  • Dose: 10 mg

  • Time point of administration: 2 minutes before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Ondansetron + dexamethasone

  • Dose: ondansetron 8 mg, dexamethasone 8 mg

  • Time point of administration: 2 minutes before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Metoclopramide + dexamethasone

  • Dose: metoclopramide 10 mg, dexamethasone 8 mg

  • Time point of administration: 2 minutes before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Placebo

  • Dose: saline

  • Time point of administration: 2 minutes before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA
Outcomes Vomiting (0 to 24 hours)

  • Outcome type: dichotomous outcome


Vomiting (0 to 6 hours)

  • Outcome type: dichotomous outcome


Vomiting (6 to 24 hours)

  • Outcome type: dichotomous outcome


Nausea (0 to 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 note on side effects
Identification Sponsorship source: NA
Country: Italy
Setting: inpatient, single‐centre
Author's name: E. Adducci
Institution: Istituto di Anestrsiologia e Rianimazioiie, Universita Callolica del Sacro Cxiore ‐ Roma
Email: NA
Address: Largo Francesco Vito, 1, 00168 Roma RM, Italy
Duration of study: NA
Language: English
Study's primary outcome: NA
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Judgement comment: quote: "using tables of random numbers"
Allocation concealment (selection bias) Unclear risk Judgement comment: quote: "sealed envelope assignment"
Not stated: sequentially numbered, opaque sealed envelopes (SNOSE)
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding ("double‐blind")
Blinding of outcome assessment (detection bias)
All outcomes Low risk Judgement comment: quote: "assessment was made by an anaesthesia resident who was blinded"
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 Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear