Kamal 1990.
| Methods | Study design: randomized parallel groups Study dates: not stated |
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| Participants | Country: Pakistan Sex: both Age: 41 ASA: I‐II Procedure: cholecystectomy Study size: 36 |
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| Interventions |
Randomized portion of anaesthetic: parts of TIVA: narcotic dose Intervention 1: induction buprenorphine 2.5 µg/kg bolus, N = 18 Intervention 2: induction buprenorphine 5 µg/kg bolus, N = 18 |
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| Outcomes | Primary outcomes: duration of anaesthesia, arterial blood pressure and heart rate data, incidence of side effects within the 2 groups Secondary outcome: awareness/wakefulness as defined using an awareness classification system (see Table 1): class 1 Quote: "None of the patients reported any awareness" |
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| Notes |
Non‐randomized portion of anaesthetic: parts of TIVA: N2O no/narcotics/hypnotics bolus MCI/muscle relaxants induction yes/maintenance yes Premedication: diazepam 0.15 mg/kg; anaesthesia induction: propofol (1 mg/kg) followed by 10 min infusion at (10 mg/kg/h) followed by 10 min infusion at (8 mg/kg/h) + pancuronium (0.1 mg/kg) + group‐specific bolus of buprenorphine (agonist‐partial antagonist (narcotic)) neuromuscular blockade at the end of surgery was reversed with neostigmine Anaesthesia maintenance: propofol infusion (6 mg/kg/h) Comment: see Dryad: advantages of total intravenous anaesthesia Time of outcome determination: 2 h postoperative Method of outcome determination: interview No email address available for ROB survey |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote "patients were randomly allocated into two groups of 18 each" |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: anaesthesiologist: "An anaesthetist unconnected with the study gave a bolus of intravenous buprenorphine so that the observer was blinded to the dose received" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: assessor: no information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing outcome data |
| Selective reporting (reporting bias) | Low risk | Comment: awareness outcome part of inclusion criteria |
| Other bias | Unclear risk | Comment: insufficient information provided |