Grundmann 2001.
| Methods | Study design: randomized parallel groups Study dates: not stated | |
| Participants | Country: Germany Sex: male and female Age: 23 to 65 ASA: I and II Procedure: elective laparoscopic cholecystectomy Study size: 50 |
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| Interventions |
Randomized portion of anaesthetic: parts of TIVA vs parts of volatile agent Intervention 1: maintenance: Group R/P: propofol 4 mg/kg/h, N = 25 Intervention 2: maintenance: Group R/D: desflurane 3% ET, N = 25 |
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| Outcomes | Primary outcomes: haemodynamic responses, recovery profile Secondary outcome: awareness/wakefulness as defined using an awareness classification system (see Table 1): class 1 Quote: "None of the patients showed any signs of wakefulness in response to surgical procedures or had postoperative recall of intraoperative events" |
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| Notes |
Non‐randomized portion of anaesthetic: parts of TIVA vs parts of volatile agent N2O no + infusion of narcotics MCI + muscle relaxant(s) induction yes/maintenance unclear Premed: 10 mg diazepam; induction: remifentanil infusion MCI (0.5 µg/kg/min) until patient felt dazed + propofol IV (2 mg/kg) + atracurium (0.5 mg/kg) + ventilation oxygen 2 L/min in air Anaesthesia maintenance: remifentanil infusion MCI reduced 0.25 µg/kg/min Comment: see Dryad author's definition of anaesthesia Time of outcome determination: after recovery Method of outcome determination: interview ROB survey. We emailed on 11 April 2015 Dr. Grundmann email: aiugru@krzsun.med‐rz.uni‐sb.de |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Fifty patients (ASA I–II, 23–65 yr) were randomly assigned" |
| Allocation concealment (selection bias) | Unclear risk | Comment: inadequate information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: anaesthesiologist: no information provided |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: assessor: "...the patients were directly transferred to the postanaesthesia care unit (PACU), where further recordings were done by an independent, blinded observer, who was unaware of the administered anaesthesia regimen" |
| 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 |