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

Pandit 1989.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 7 groups, monoprophylaxis and combination prophylaxis, dose‐finding study
Participants Baseline characteristics
Metoclopramide (5 mg group)

  • Assessed for eligibility (n): NA

  • Enrolled (n): NA

  • Randomized (n): 20

  • Received treatment (n): 20

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 30.3 ± 6.59

  • Weight (mean ± SD, median (IQR), median (range)): 63 ± 15

  • 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 (%): NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 68.0

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

  • Type of surgery: laparoscopy


Metoclopramide (10 mg group)

  • Assessed for eligibility (n): NA

  • Enrolled (n): NA

  • Randomized (n): 20

  • Received treatment (n): 20

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 31.1 ± 7.11

  • Weight (mean ± SD, median (IQR), median (range)): 65 ± 13

  • 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 (%): NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 67.0

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

  • Type of surgery: laparoscopy


Droperidol (5 µg/kg group)

  • Assessed for eligibility (n): NA

  • Enrolled (n): NA

  • Randomized (n): 20

  • Received treatment (n): 20

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 30.0 ± 7.24

  • Weight (mean ± SD, median (IQR), median (range)): 63 ± 16

  • 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 (%): NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 69.8

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

  • Type of surgery: laparoscopy


Droperidol (10 µg/kg group)

  • Assessed for eligibility (n): NA

  • Enrolled (n): NA

  • Randomized (n): 20

  • Received treatment (n): 20

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 30.3 ± 5.65

  • Weight (mean ± SD, median (IQR), median (range)): 60 ± 10

  • 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 (%): NA

  • Type of general anaesthesia: Inhalational anaesthesia (enflurane, N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 71.5

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

  • Type of surgery: laparoscopy


Droperidol (20 µg/kg group)

  • Assessed for eligibility (n): NA

  • Enrolled (n): NA

  • Randomized (n): 20

  • Received treatment (n): 20

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 29.0 ± 5.68

  • Weight (mean ± SD, median (IQR), median (range)): 63 ± 13

  • 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 (%): NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 65.1

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

  • Type of surgery: laparoscopy


Placebo

  • Assessed for eligibility (n): NA

  • Enrolled (n): NA

  • Randomized (n): 20

  • Received treatment (n): 20

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 31.5 ± 4.49

  • Weight (mean ± SD, median (IQR), median (range)): 64 ± 16

  • 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 (%): NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 64.8

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

  • Type of surgery: laparoscopy


Metoclopramide + droperidol

  • Assessed for eligibility (n): NA

  • Enrolled (n): NA

  • Randomized (n): 20

  • Received treatment (n): 20

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 29.0 ± 6.51

  • Weight (mean ± SD, median (IQR), median (range)): 65 ± 10

  • 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 (%): NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 65.0

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

  • Type of surgery: laparoscopy


Included criteria: female, ASA I or II, scheduled for an outpatient laparoscopy, participated in this study
Excluded criteria: NA
Pretreatment: baseline characteristics (age, ASA, weight): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Metoclopramide (5 mg group)

  • Dose: 5 mg

  • Time point of administration: 30 minutes before induction of anaesthesia, placebo 2 minutes before induction

  • Route of administration: orally, placebo IV

  • Rescue antiemetics (if yes, which?): prochlorperazine 5 mg, droperidol 0.6 mg


Metoclopramide (10 mg group)

  • Dose: 10 mg

  • Time point of administration: 30 minutes before induction of anaesthesia, placebo 2 minutes before induction

  • Route of administration: orally, placebo IV

  • Rescue antiemetics (if yes, which?): prochlorperazine 5 mg, droperidol 0.6 mg


Droperidol (5 µg/kg group)

  • Dose: 5 µg/kg

  • Time point of administration: 2 minutes before induction of anaesthesia, placebo 30 minutes before induction of anaesthesia

  • Route of administration: IV, placebo orally

  • Rescue antiemetics (if yes, which?): prochlorperazine 5 mg, droperidol 0.6 mg


Droperidol (10 µg/kg group)

  • Dose: 10 µg/kg

  • Time point of administration: 2 minutes before induction of anaesthesia, placebo 30 minutes before induction of anaesthesia

  • Route of administration: IV, placebo orally

  • Rescue antiemetics (if yes, which?): prochlorperazine 5 mg, droperidol 0.6 mg


Droperidol (20 µg/kg group)

  • Dose: 20 µg/kg

  • Time point of administration: 2 minutes before induction of anaesthesia, placebo 30 minutes before induction of anaesthesia

  • Route of administration: IV, placebo orally

  • Rescue antiemetics (if yes, which?): prochlorperazine 5 mg, droperidol 0.6 mg


Placebo

  • Dose: NA

  • Time point of administration: 30 minutes and 2 minutes before induction of anaesthesia

  • Route of administration: orally/IV

  • Rescue antiemetics (if yes, which?): prochlorperazine 5 mg, droperidol 0.6 mg


Metoclopramide + droperidol

  • Dose: metoclopramide 10 mg, droperidol 10 µg/kg

  • Time point of administration: metoclopramide 30 minutes before induction of anaesthesia; droperidol 2 minutes before induction of anaesthesia

  • Route of administration: metoclopramide orally; droperidol IV

  • Rescue antiemetics (if yes, which?): prochlorperazine 5 mg, droperidol 0.6 mg
Outcomes Vomiting (in the PACU)

  • 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, single‐centre
Author's name: Sujit K. Pandit
Institution: Department of Anesthesiology, University of Michigan Medical Center, Ann Arbor, MI, USA
Email: NA
Address: Department of Anesthesiology, University of Michigan Medical Center, 1500 East Medical Center Drive, Box 0048, Ann Arbor, MI 48109, USA
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 Quote: "following a computer‐ generated random list."
Allocation concealment (selection bias) Unclear risk Judgement comment: insufficient information on allocation concealment provided
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "a nurse not involved in any of the subsequent evaluations, dispensed and administered the medications"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "the same blinded observer (SPK) performed all the assessments in the recovery room and conducted telephone follow‐up after 24 hours"
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, ASA, weight): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear