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

Bjerregaard 2018.

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

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 59

  • Received treatment (n): 59

  • Analysed (n): 49

  • Age (mean ± SD, median (IQR), median (range)): 68 (61 to 75)

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

  • BMI (mean ± SD, median (IQR), median (range)): 21.2 ± 4.0

  • ASA I/II/III/IV (n): 3/30/23/0

  • Gender (female in %): 64

  • Non‐smoker (%): 77

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

  • Type of general anaesthesia: TIVA (propofol/remifentanil)

  • Duration of anaesthesia or surgery (in min; as mean or median): 104

  • Use of perioperative opioids (if yes, which?): remifentanil for anaesthesia, 5 mg morphine postoperative day 0, 0 mg morphine postoperative day 1, 0 mg morphine postoperative day 2

  • Type of surgery: elective VATS lobectomy


Placebo

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 60

  • Received treatment (n): 60

  • Analysed (n): 47

  • Age (mean ± SD, median (IQR), median (range)): 66.5 (60 to 73)

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

  • BMI (mean ± SD, median (IQR), median (range)): 21.8 ± 3.9

  • ASA I/II/III/IV (n): 8/18/30/0

  • Gender (female in %): 47

  • Non‐smoker (%): 74

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

  • Type of general anaesthesia: TIVA (propofol/remifentanil)

  • Duration of anaesthesia or surgery (in min; as mean or median): 102

  • Use of perioperative opioids (if yes, which?): remifentanil for anaesthesia, 5 mg morphine postoperative day 0, 0 mg morphine postoperative day 1, 0 mg morphine postoperative day 2

  • Type of surgery: elective VATS lobectomy


Included criteria: consenting patients over 18 years of age who underwent elective VATS lobectomy at the Department of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital, Denmark
Excluded criteria: inability to cooperate; inability to speak or understand Danish; no planned follow‐up at Rigshospitalet; allergies to any used medicines; symptomatic gastric ulceration; New York Heart Association functional classification of III or more; preoperative increased plasma creatinine; pharmacologically treated diabetes mellitus; abuse of medicine or alcohol (over 5 units/d); use of psychopharmacological agents, systemic steroids (except inhalations), and/or opioid agonists; neurological deficits affecting pain perception; previous ipsilateral pulmonary resection; pregnant and/or breastfeeding. Included patients were withdrawn if they were re‐operated on within 72 hours, had massive intrathoracic adherences, deviated from the standard postoperative analgesia, converted to thoracotomy, and/or breached protocol rules
Pretreatment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, perioperative opioids): no; (history of PONV/motion sickness): unclear
Interventions Intervention characteristics
Methylprednisolone

  • Dose: 125 mg

  • Time point of administration: after induction of anaesthesia, but before the start of surgery

  • Route of administration: IV

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


Placebo

  • Dose: 2 mL saline

  • Time point of administration: after induction of anaesthesia, but before the start of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA
Outcomes Arrhythmia (during study period)

  • Outcome type: dichotomous outcome


Visual disturbances (e.g. blurred vision) (during study period)

  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, study period)

  • Outcome type: general notes on side effects
Identification Sponsorship source: supported by the ‘Doctor Fritz Karner and wife Edith Karner’s Foundation’ and the ‘Doctor Edgar Schnohr and wife Gilberte Schnohr’s Foundation’
Country: Denmark
Setting: inpatient, single‐centre
Author's name: Lars S. Bjerregaard
Institution: Rigshospitalet, Copenhagen University, Copenhagen East, Denmark
Email: lars.stryhn.bjerregaard@regionh.dk
Address: Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen University, Blegdamsvej 9, Section 7621, 2100 Copenhagen, Denmark
Language: English
Duration of study: 21 March 2013 to 23 September 2015
Trial registry number: EUCTR2012‐004451‐37
Study's primary outcome: pain in the first 48 hours postoperatively
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer‐generated randomization sequence"
Allocation concealment (selection bias) Low risk Quote: "before the start of the study, 100 sealed opaque envelopes were prepared by persons with no relation to the study"
Judgement comment: quote: "opened the next envelope"
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "patients, caregivers and investigators were blinded to group assignment"
Quote: "...depending on the enclosed information. The syringe was blinded by a plaster bandage and brought to the investigator who administered the medicine to the patient after induction of anaesthesia..."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "patients, caregivers and investigators were blinded to group assignment"
Quote: "postoperative pain, nausea and sedation were scored by trained nurses every 3rd hour from arrival in the PACU until midnight on the day of surgery"
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "one (1%) patient withdrew informed consent and 23 (19%) patients were withdrawn by the investigators, leaving 96 (80%) patients for the final analysis"
Judgement comment: high rate of missing data. Participants withdrawn by investigators > 15%, but reasons described and unrelated to outcomes of interest
Selective reporting (reporting bias) Low risk Judgement comment: EUCTR2012‐004451‐37 (prospective registration). The prospectively registered primary outcome (pain) was reported in the pre‐specified way in the final study report. The primary outcome was not PONV‐related
Other bias Unclear risk Quote: "baseline characteristics and perioperative data are presented in Tables 2 and 3, and with the exception of gender, these showed an acceptable balance between the groups"
Judgement comment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, perioperative opioids): no; (history of PONV/motion sickness): unclear