Maattanen 2002.
| Methods | Study design: randomized parallel groups Study dates: not stated |
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| Participants | Country: Sweden Sex: female and male Age: 44 and 49 ± 13 and 10 ASA: I‐II Procedure: elective open spine surgery Study size: 30 |
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| Interventions |
Randomized portion of anaesthetic: ADM vs SCP Intervention 1: Group I (N = 15), maintenance: desflurane and 50% N2O, was titrated with a target AAI‐index of 20 ± 5 Intervention 2: Group II (N = 15), maintenance: desflurane and 50% N2O, titrated according to routine clinical signs (SCP): heart rate, blood pressure, sweating and tears. No pre‐defined fixed MAC‐multiple was administered |
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| Outcomes | Primary outcomes: anaesthetic consumption determination (desflurane vaporiser was filled and weighed and re‐weighed at end) Secondary outcome: awareness/wakefulness as defined using an awareness classification system (see Table 1): class 1 Quote: "no patients showed signs of awareness or had any recall postoperatively" |
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| Notes |
Non‐randomized portion of anaesthetic: parts of inhalation or volatile agent/N2O yes + supplemental narcotics (balanced anaesthesia)/muscle relaxant induction yes/maintenance unclear/random ADM (AAI: 20) vs SCP AAI‐index of 20 ± 5 ADM (AAI: 20) vs SCP: inhalational: desflurane/N2O Premed betamethasone 8 mg IV, induction: propofol as needed, fentanyl 0.5 mg and vecuronium/intubation, controlled ventilation, fentanyl 50 µg PRN and then 2% desflurane if needed Fentanyl 50mg PRN both groups if need haemodynamic control after sequential 2% increase in desflurane...No other drugs were given during the desflurane anaesthesia Comment see Dryad topic definition Evan's score and AAI targets with and without muscle relaxants ROB survey emailed 03 January 2014 jan.jacobsson@mm‐medical.se; delivery failed |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomised by the envelope technique" |
| Allocation concealment (selection bias) | Unclear risk | Comment: see above |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The same anaesthetist (JJ), with 1 year’s experience with the A‐line monitor, performed all anaesthesia’s and, by the nature of the study, was non‐blinded. The postoperative nursing staff was blinded" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "grading by nurses otherwise not involved in the study...interviewed in the recovery room...explicit memories from surgery or anaesthesia" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing data |
| Selective reporting (reporting bias) | Low risk | Comment: awareness outcome part of inclusion criteria |
| Other bias | Unclear risk | Comment: inadequate information provided |