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

Fukami 2009.

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

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 58 ± 15

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

  • BMI (mean ± SD, median (IQR), median (range)): 24.4 ± 4.5

  • ASA I/II/III/IV (n): 37/2/1/0

  • Gender (female in %): 42.5

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 130

  • Use of perioperative opioids (if yes, which?): 0.1 mg fentanyl at induction

  • Type of surgery: laparoscopic cholecystectomy


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 56 ± 14

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

  • BMI (mean ± SD, median (IQR), median (range)): 24.7 ± 3.4

  • ASA I/II/III/IV (n): 35/4/1/0

  • Gender (female in %): 37.5

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 130

  • Use of perioperative opioids (if yes, which?): 0.1 mg fentanyl at induction

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: undergoing laparoscopic cholecystectomy
Excluded criteria: ASA IV, older than 80 years of age, pregnancy, treatment with steroids, severe diabetes mellitus (HbA1c > 8.5%), use of opioids or tranquilizers less than 1 week before LC, history of alcohol or drug abuse, preoperative diagnosis of gallbladder carcinoma, acute pancreatitis, emergency operation, conversion from LC to an open procedure
Pretreatment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear
Interventions Intervention characteristics
Dexamethasone
  • Dose: 8 mg

  • Time point of administration: 90 minutes before skin incision

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV


Placebo
  • Dose: saline

  • Time point of administration: 90 minutes before skin incision

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV

Outcomes Postoperative wound infection (postoperative complications were recorded during hospitalization, and patients were followed up at least once after discharge)
  • 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: Japan
Setting: inpatient, single‐centre
Author's name: Y. Fukami
Institution: Department of Surgery, Shizuoka Saiseikai General Hospital, Shizuoka 422‐8527, Japan
Email: yasuyuki490225@yahoo.co.jp
Address: Department of Surgery, Shizuoka Saiseikai General Hospital, Shizuoka 422‐8527, Japan
Duration of study: January 2006 to May 2008
Language: English
Study's primary outcome: incidence of nausea and vomiting
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "...using an equal number of blind envelopes"
Judgement comment: insufficient information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Quote: "...using an equal number of blind envelopes"
Judgement comment: 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 Unclear risk Judgement comment: insufficient information on blinding ("double‐blind")
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "eighteen patients were excluded from the study, because of age more than 80 years (n = 8), lack of consent (n = 2), bile duct injury (n = 1), acute pancreatitis (n = 1) and conversion from LC to an open procedure (n = 6; 6%). A total of 80 LC patients were enrolled (Fig. 1), 40 being randomized to intravenous dexamethasone (8 mg) and 40 to placebo"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Unclear risk Quote: "...the hospital for 3 days. There were no significant differences between the two groups with regard to mean age, gender, BMI, preoperative CRP level, ASA score, or anesthesia and operation times (Tables 1, 2). Seven patients..."
Judgement comment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear