Skip to main content
. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Sanchez Rodriguez 2010.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Placebo

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 105

  • Received treatment (n): NA

  • Analysed (n): 105

  • Age (mean ± SD, median (IQR), median (range)): 36.3 ± 7.3

  • Weight (mean ± SD, median (IQR), median (range)): 70.5 ± 7.7

  • BMI (mean ± SD, median (IQR), median (range)): 26.2 ± 3.0

  • ASA I/II/III/IV (n): 63/42/0/0

  • Gender (female in %): 61.90

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 105.3

  • Use of perioperative opioids (if yes, which?): 3 µg/kg to 5 µg/kg fentanyl at induction, 23.9 (number of additional buprenorphine doses was significantly lower in the study group)

  • Type of surgery: laparoscopic cholecystectomy


Dexamethasone

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 105

  • Received treatment (n): NA

  • Analysed (n): 105

  • Age (mean ± SD, median (IQR), median (range)): 37.7 ± 7.7

  • Weight (mean ± SD, median (IQR), median (range)): 72.3 ± 7.4

  • BMI (mean ± SD, median (IQR), median (range)): 26.7 ± 3.0

  • ASA I/II/III/IV (n): 63/42/0/0

  • Gender (female in %): 53.33

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 104.8

  • Use of perioperative opioids (if yes, which?): 3 µg/kg to 5 µg/kg fentanyl at induction, 18.6 (number of additional buprenorphine doses was significantly lower in the study group)

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: undergoing laparoscopic cholecystectomy
Excluded criteria: ASA III and IV; over 80 years of age; pregnancy; treatment with steroids; severe diabetes mellitus (haemoglobin A1c (HbA1c) > 8%); use of opioids, sedatives, or any kind of analgesic 1 week before LC; history of alcohol or drug abuse; preoperative diagnosis of acute cholecystitis, acute pancreatitis, choledocholithiasis, gallbladder carcinoma; conversion of the LC to an open procedure
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker): unclear; (perioperative opioids): yes
Interventions Intervention characteristics
Placebo

  • Dose: placebo

  • Time point of administration: 60 minutes before skin incision

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 36.19% (ondansetron 4 mg to 8 mg IV)


Dexamethasone

  • Dose: 8 mg

  • Time point of administration: 60 minutes before skin incision

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 15.24% (ondansetron 4 mg to 8 mg IV)
Outcomes Vomiting (PACU)

  • Outcome type: dichotomous outcome


Vomiting (PACU to 6 hours)

  • Outcome type: dichotomous outcome


Postoperative wound infection (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: Mexico
Setting: inpatient, single‐centre
Author's name: A. González‐Ojeda
Institution: Research Unit in Clinical Epidemiology, Specialties Hospital, Western Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico
Email: avygail5@yahoo.com.mx
Address: Calle Jose ´E. Rodo #2558, Colonia Prados Providencia,Guadalajara, Jalisco 44670, Mexico
Duration of study: from January 2007 to August 2008
Language: English
Study's primary outcome: incidence of nausea and vomiting.
Trial registry number: NCT01030614
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomized to receive intravenous dexamethasone (8 mg) or homologated placebo 60 min before skin incision, using an equal number of blind envelopes"
Judgement comment: shuffling envelopes
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: "a total of 105 patients were randomized to receive intravenous dexamethasone (8 mg) and 105 to be given a placebo. All patients were admitted the day of the scheduled surgical procedure and stayed in the hospital for at least one night after LC"
Judgement comment: no missing outcome data
Selective reporting (reporting bias) Unclear risk Judgement comment: NCT01030614 (retrospective registration)
Other bias High risk Quote: "there were no significant differences between the two groups with regard to mean age, sex, BMI, ASA score, previous surgical procedures (Table 1), during of surgical procedures and length of anesthesia, hospital stay, or postoperative morbidity (Table 2)"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker): unclear; (perioperative opioids): yes