Ghosh 2011.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis and combination prophylaxis |
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Participants |
Baseline characteristics Palonosetron
Palonosetron + dexamethasone
Included criteria: ASA I and II, 18 to 60 years of age, weighing 40 to 70 kg, scheduled for elective laparoscopic surgery under general anaesthesia Excluded criteria: pregnant or menstruating, gastrointestinal or renal disease, received cancer chemotherapy within past 4 weeks, emetogenic radiotherapy within past 8 weeks, had experienced nausea or vomiting, had taken antiemetic medication within 24 hours before surgery Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear |
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Interventions |
Intervention characteristics Palonosetron
Palonosetron + dexamethasone
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Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 2 hours)
Vomiting (2 to 24 hours)
Complete response (no PONV) in 24 hours
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: departmental funding only Country: India Setting: Inpatient, single‐centre Author's name: Dr. Anirban Pal Institution: Department of Anesthesiology, Calcutta National Medical College (CNMC), Kolkata, India Email: pal.anirban1@gmail.com Address: 43/6/5 Jheel Road, Kolkata ‐ 700 031, West Bengal, India Language: English Duration of study: NA Trial registry number: NA Study's primary outcome: NA |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "the patients were randomly (computer‐generated numbers inserted into opaque envelope) allocated to two groups P and PD" |
Allocation concealment (selection bias) | Unclear risk | Quote: "the patients were randomly (computer‐generated numbers inserted into opaque envelope) allocated to two groups P and PD..." Judgement comment: not stated if envelopes were sequentially numbered and sealed (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "a consultant anesthesiologist who performed general anesthesia and used the study drug, was unaware of the type of study drug used and did not participate in the study" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "...paracetamol 1 g (100 ml). Patients were asked about nausea, vomiting, retching and any side‐effects, at 2, 6, 24, 48 h by an investigator. The investigator and the patients were blinded to the study drug used. The severity of PONV..." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: no missing outcome data |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear |