Corcoran 2017.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis and combination prophylaxis |
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Participants |
Baseline characteristics Granisetron
Dexamethasone + granisetron
Included criteria: adult females, ASA I or II, 18 to 60 years of age, undergoing elective major laparoscopic gynaecological surgery expected to require at least 90 minutes of operative time, requiring a hospital stay to include at least the first postoperative night Excluded criteria: currently or recently taking immunosuppressive agents; had known or suspected malignancy, hypertension, or diabetes mellitus; history of peptic ulceration, chronic pain syndrome requiring regular opioid consumption, a predicted requirement for IV patient‐controlled analgesia, or known hypersensitivity to dexamethasone or granisetron Pretreatment: history of PONV/motion sickness |
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Interventions |
Intervention characteristics Granisetron
Dexamethasone + granisetron
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Outcomes |
Vomiting (PACU)
Postoperative wound infection (day two)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: Royal Perth Hospital (departmental funds); Health Department of Western Australia (Raine Foundation Clinical Practitioner Fellowship to T.C.); University of Western Australia (T.C.). Country: Australia Setting: inpatient, single‐centre Author's name: Tomas Corcoran Institution: Department of Anaesthesia and Pain Medicine, Royal Perth Hospital Email: tomas.corcoran@health.wa.gov.au Address: Royal Perth Hospital, Box X2213 GPO Perth 6847, Western Australia, Australia Duration of study: February 2010 to March 2013 Language: English Study's primary outcome: NA Trial registry number: ACTRN12608000340336 |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were randomized before surgery, in a 1:1 ratio, using a computer‐generated random number sequence" |
Allocation concealment (selection bias) | Unclear risk | Quote: "and allocated to one of two groups using sealed opaque envelopes" Judgement comment: not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the study drug was prepared by an observer who was not connected to the study and diluted to a total volume of 4 ml with 0.9% sodium chloride in an unmarked syringe" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the patient, the patient’s anaesthetist, and all investigators were blinded to the study drug identity" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "of failure to comply with the study protocol, leaving data on 31 patients to be analysed. Two patients in each group did not complete cell count testing at 48 h, and five patients in the Control group and four in the Dexamethasone group did not complete cell count testing at 6 weeks after surgery" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: ACTRN12608000340336 (prospective registration). The prospectively registered primary outcome (T‐ and B‐cell population) was reported in the protocol without any timing of assessment. The study paper included time measurements for the primary outcome at 24 hours, 7 days, and 6 weeks from baseline values. The focus of the study was not PONV, and primary and secondary outcomes were not defined in the study report |
Other bias | High risk | Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids, history of PONV/motion sickness): no; (non‐smoker): yes |