Mozafari 2014.
| Methods | Study design: randomized parallel groups Study dates: not stated | |
| Participants | Country: Iran Sex: male/female Age: mean 47 and 48; range 18 to 65 ASA: I‐III Procedure: elective abdominal surgery (laparoscopy, cholecystectomy) Study size: 392 enrolled, 333 completed study | |
| Interventions |
Randomized portion of anaesthetic: ADM BIS values (target range: 45 to 65) vs SCP: volatile agent Intervention 1: BIS monitoring (N = 163) BIS values (target range: 45 to 65) Intervention 2: routine monitoring (N = 170) |
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| Outcomes | Primary outcomes: BIS values and vital parameters including systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and SPO2 Secondary outcomes: awareness/wakefulness as defined using an awareness classification system (see Table 1): class 4 Quote: "The overall incidence of awareness in the BIS and routine monitoring groups were 5.5% and 4.1%, which was not significantly different" Comment: total awareness events 16 |
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| Notes |
Randomized portion of anaesthetic: parts of volatile agent/N2O yes + supplemental narcotics + muscle relaxant induction yes/maintenance unclear Anaesthesia induced: sufentanil 0.1 μg to 0.2 μg/kg, thiopental 3 mg to 5 mg/kg and atracurium 0.5 mg/kg maintained isoflurane or halothane/N2O/BIS Comment: the reported awareness events from this RCT suggests that there is something unusual about the method of administration of anaesthesia compared to other RCTs in this review from other countries with similar interventions but lower awareness rates or the criteria or protocol that other studies use to identify or include patient awareness reports is different. The difference maybe related to 1) the percentage of illiterate patients in study and/or 2) the validated awareness questionnaire specific to Persian culture (Malek 2010a) Quote: "However, it seems that the incidence of this phenomenon and its complications are exactly dependent on the quality of postoperative interview by specialists. It has been shown that detection of awareness depends on the technique, timing and structure of interview ..." Comment: Brice interview is NOT validated Author: Amir Asadi Fakhr, Department of Anesthesiology, School of Paramedicine, Hamadan University of Medical Sciences, Hamadan, IR Iran. Tel: +98‐9183159883, Email: asadi@umsha.ac.ir ROB survey. We emailed asadi@umsha.ac.ir on 22 March 2015; no response 17 April 2015 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "We considered about 196 samples for each group. Patients were allocated to BIS monitoring (n = 163) and routine monitoring (n = 170) groups using the permuted block randomization method" |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: personnel knew treatment group assignment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "In addition, information related to the awareness during anesthesia was collected by a special questionnaire including formalized set of open‐ended questions" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "We considered about 196 samples for each group. Patients were allocated to BIS monitoring (n = 163) and routine monitoring (n = 170) groups using the permuted block randomization method. Nevertheless, 30 and 26 persons disagreed to participate in the study (BIS monitoring n = 163 and routine monitoring n = 170)" Comment: exclusions before surgery started; no exclusions between groups that started and finished surgery |
| Selective reporting (reporting bias) | Low risk | Comment: awareness outcome part of inclusion criteria |
| Other bias | Unclear risk | Comment: no information |