Puri 2007.
| Methods | Study design: randomized parallel groups Study dates: "Feb 2003 to Dec 2004" (email bias survey, see notes) |
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| Participants | Country: India Sex: both Age: 39 Procedure: elective non‐cardiac surgery Study size: 40 |
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| Interventions |
Randomized portion of anaesthetic: TIVA + CLADS vs TIVA + ADM: BIS 50 Intervention 1: closed loop anaesthesia delivery system (CLADS): propofol 5.03 ± 1.68 mg/kg‐1, h‐1 Intervention 2: manual infusion control: 7.33 ± 2.07 mg/kg‐1, h‐1 propofol titrated to BIS = 50 |
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| Outcomes | Primary outcomes: induction time (the time required to achieve target BIS after start of infusion), induction dose, minimum BIS within 30 seconds of induction, total dose propofol, median duration of closed loop control or manual control, and median time interval between end of closed‐loop control (or end propofol infusion in manual control) and extubation Secondary outcome: awareness/wakefulness as defined using an awareness classification system (see Table 1): class 1 Comment: no awareness cases |
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| Notes |
Non‐randomized portion of anaesthetic: parts of TIVA/N2O no: narcotics MCI/muscle relaxants induction yes/maintenance yes (CPB) Anaesthesia induction: fentanyl (2 µg/kg) prior to induction than fentanyl 1 µg/kg‐1, h‐1 continuous infusion for the duration of surgery; endotracheal intubation/0.1 mg/kg vecuronium Anaesthesia maintenance: fentanyl infusion (1 µg/kg/h) Time of outcome determination: at discharge, 1 day, and 1 week postoperative Method of outcome determination: modified Brice questionnaire Survey response: 16 February 2011, Dr Goverdhan Dutt Puri gdpuri007@hotmail.com |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote ROB survey response, Dr Puri: "Computer generated" (email bias survey, see notes) |
| Allocation concealment (selection bias) | High risk | Quote ROB survey response, Dr Puri: "Anaesthesiologist conducting anaesthesia knew of the group the patient belong. But anaesthesiologist assessing awareness post‐op did not know the group to which patient belong" (email bias survey, see notes) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: given the closed vs open loop systems used, like Pedersen 1992, it is possible to blind the anaesthesiologist but requires extra manpower |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote ROB survey response, Dr Puri: "Patient, Awareness outcome assessor (interviewer), Data analyst...But anaesthesiologist assessing awareness post‐op did not know the group to which patient belong" (email bias survey, see notes) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote ROB survey response, Dr Puri: "all data reported" |
| Selective reporting (reporting bias) | Low risk | Quote ROB survey response, Dr Puri: "...don't think any non significant results of any importance to the study relevant were excluded" (email bias survey, see notes) Comment: awareness outcome part of inclusion criteria |
| Other bias | Low risk | Quote ROB survey response, Dr Puri: "free of bias as all patients had anaesthesia to be controlled on target BIS numbers" (email bias survey, see notes) |