Bestas 2004.
| Methods | Study design: randomized parallel groups Study dates: "2003" (email survey) |
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| Participants | Country: Turkey Sex: both Age: 59.6 ASA: not available Procedure: off‐pump CABG surgery Study size: 50 | |
| Interventions |
Randomized portion of anaesthetic: IV bolus MCI ADM (BIS) vs SCP Intervention 1: induction: fentanyl (7 µg to 15 µg/kg) + propofol (2 mg to 2.5 mg/kg); maintenance: fentanyl (15 µg/kg/h) + propofol (6 mg/kg/h), N = 25 Intervention 2: induction: fentanyl (7 µg to 15 µg/kg) + midazolam (0.1 mg to 0.3 mg/kg); maintenance: fentanyl (15 µg/kg/h) + midazolam 0.1 mg/kg/h, N = 25 Comment: depth of anaesthesia was based on clinical signs. BIS values were not shown |
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| Outcomes | Primary outcomes: awareness/wakefulness as defined using an awareness classification system (see Table 1): class 1 "No patients were noted to recall the sounds presented during the operation and the preoperative events...no patients reported to have heard anything or had any dreams intraoperatively" |
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| Notes |
Non‐randomized portion of anaesthetic: parts of IV:/N2O no/narcotics/hypnotics bolus MCI/muscle relaxants induction yes/maintenance yes Anaesthesia induction: fentanyl (7 µg to 15 µg/kg) + group‐specific study drug (see above) + vecuronium (0.1 mg/kg). Anaesthesia maintenance: fentanyl (15 µg/kg/h) + group‐specific study drug (see above) + vecuronium 0.02 mg/kg as needed Time of outcome determination: 24 h after surgery Method of outcome determination: standardized questionnaire Author responded to email survey Survey response: 24 January 2011 Azize Bestas, abestas@firat.edu.tr Email sent to clarify allocation on 26 November 2013 to Azize Bestas, abestas@firat.edu.tr |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomly divided into two groups" Quote (email bias survey): "A random numbers table was used" |
| Allocation concealment (selection bias) | High risk | Quote (email bias survey): "Anesthesia was administered to patients by an anaesthesiologist not blinded to the study allocation (blinded for BIS values)" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Patient, Anesthesiologist, Awareness outcome assessor (interviewer)" Comment: although many authors define ADM vs SCP as a blinded method, SCP is exposed to both groups |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Patient, Anesthesiologist, Awareness outcome assessor (interviewer)" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no dropouts |
| Selective reporting (reporting bias) | Low risk | Quote: "There is no any important risk of bias." (Email bias survey, see notes) Comment: awareness outcome part of inclusion criteria |
| Other bias | Low risk | Quote: "There is no any important risk of bias." (Email bias survey, see notes) |