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

Schultz 2003.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Droperidol
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 24

  • Age (mean ± SD, median (IQR), median (range)): 50.2 ± 13.7

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

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 197

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

  • Type of surgery: vaginal or total abdominal hysterectomy, laparoscopy, tubal ligation, tubal re‐anastomosis, bladder suspension, Burch procedure, anterior‐posterior repair or myomectomy


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 25

  • Age (mean ± SD, median (IQR), median (range)): 47.7 ± 12.3

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

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 153

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

  • Type of surgery: vaginal or total abdominal hysterectomy, laparoscopy, tubal ligation, tubal re‐anastomosis, bladder suspension, Burch procedure, anterior‐posterior repair or myomectomy


Included criteria: over 18 years of age, able to read and write English, low risk of anaesthesia issues, scheduled for inpatient surgery after gynaecological surgery
Excluded criteria: pregnancy, surgery for cancer within previous 5 years, chemotherapy or radiation therapy within 5 years, antiemetic within 24 hours before surgery, previous use of acupressure bands, peripheral neuropathy
Pretreatment: baseline characteristics (age): no; (weight, BMI, ASA): unclear. Potential effect modifiers (gender): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear; (duration of anaesthesia): yes
Interventions Intervention characteristics
Droperidol
  • Dose: 1.25 mg

  • Time point of administration: before or with induction, "an anesthesiologist gave the study drug and documented the time of administration"

  • Route of administration: IV

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


Placebo
  • Dose: NA

  • Time point of administration: before or with induction, "an anesthesiologist gave the study drug and documented the time of administration"

  • Route of administration: IV

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

Outcomes Nausea (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: Seabands UK Ltd contributed the Seabands for the study
Country: USA
Setting: inpatient, single‐centre
Author's name: Alyce A. Schultz
Institution: New England Rehabilitation Hospital of Portland
Email: Schula@mmc.org
Address: Alyce A. Schultz, RN, PhD, Nurse Researcher, Maine Medical Center, 22 Bramhall Street, Portland, ME 04102, USA
Duration of study: July 1999 to August 2000
Language: English
Study's primary outcome: nausea
Trial registry number: NA
Notes Two out of 4 groups relevant (acupressure bands)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Judgement comment: quote: "random table number"
Allocation concealment (selection bias) Unclear risk Judgement comment: quote: "study envelopes ... were prepared by the principal investigator and the study pharmacist..."
Not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE). Unclear who performed randomization
Blinding of participants and personnel (performance bias)
All outcomes High risk Judgement comment: quote: "the envelope containing the study group designation was opened by the admitting nurse and placed on the front of the subject's chart" "An anesthesiologist gave the study drug". Study personnel probably was not blinded
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement on blinding of outcome assessors
Incomplete outcome data (attrition bias)
All outcomes High risk Judgement comment: quote: "one hundred and forty‐three women consented the study. One hundred and three women completed the hospital phase of the study...the most frequent reason for attrition was non‐administration of the study drug". High rate of missing outcome data (> 15%)
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias High risk Judgement comment: baseline characteristics (age): no; (weight, BMI, ASA): unclear. Potential effect modifiers (gender): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear; (duration of anaesthesia): yes