Tomar 2017.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Placebo (group B)
Dexamethasone (group D)
Included criteria: ASA I or II, either sex, 18 to 65 years of age, undergoing elective unilateral nephrectomy Excluded criteria: history of anaphylaxis to local anaesthetics, diabetes, hypertension, cyanotic heart disease, pregnancy, neurological and respiratory disease, coagulopathy, acid peptic disease 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 |
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Interventions |
Intervention characteristics Placebo (group B)
Dexamethasone (group D)
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Outcomes |
PONV (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: India Setting: inpatient, single‐centre Author's name: Gaurav Singh Tomar Institution: Department of Anaesthesiology and Critical Care, St. Stephen’s Hospital, Delhi, India Email: spunkygst@gmail.com Address: Flat‐5C, Vidhata Apartment, Vasundhara enclave, Delhi‐96, India Duration of study: NA Language: English Study's primary outcome: NA Trial registry number: NA |
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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 randomly allocated using a computer‐generated randomization list into 2 groups (n 5 30)" |
Allocation concealment (selection bias) | Unclear risk | Quote: "sealed envelops containing one syringe with bupivacaine and saline or bupivacaine and dexamethasone were prepared by an anesthesiology resident not involved in this study" Judgement comment: not stated; "sequentially numbered, opaque" envelopes (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the enrolled patient, concerned anesthesiologist, and surgeon were unaware of the nature of the drug in each syringe" Quote: "sealed envelops containing one syringe with bupivacaine and saline or bupivacaine and dexamethasone were prepared by an anesthesiology resident not involved in this study" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "all patients were observed postoperatively by anesthesiology resident who was unaware of the study group" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "among 60 patients, 6.67% (2 patients) in group D and 10% (3 patients) in group B were declared as failure to perceive desired effect with medications given. These 5 patients were excluded from the study (Figure 1). Hence, 57 patients were available for data analysis" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | High risk | Quote: "demographic variables in terms of age, gender, body weight, and height were found to be comparable along with duration of surgery in both groups (P. 0.05) (Table 1). The groups were also comparable regarding fentanyl and propofol consumption during intraoperative period (P. 0.05) (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 |