Inaba 2007.
| Methods | Single‐centre randomized controlled trial. Study period: March 2003 to June 2003 | |
| Participants | Total number of patients 18. All males, age less than 75 years. Undergoing mechanical ventilation until 6:30 AM next day after head and neck surgery in an ICU in Japan. Patients admitted after brain surgery excluded. No critical illness severity score reported. ASA 1‐2 Sedation protocol used: Fentanyl 10 mcg/kg/hour, propofol 6 mg /kg/hour to 10 mg/kg/hour. Target Bispectral Index (BIS) score 40‐70, target Ramsay score 4‐5. Propofol titrated as per BIS monitoring or Ramsay score |
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| Interventions | BIS monitoring (N = 9) versus Ramsay score (N = 9). Frequency of monitoring every hour | |
| Outcomes | Apart from average propofol dose, no other primary or secondary outcome of interest for the review was reported. Other outcome reported include time to eye‐opening, time to consciousness, number of flow rate changes and number of boluses | |
| Notes | Study funding sources not specified No possible conflict of interest reported We were unable to contact the study authors for more details as no email ID was found |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly allocated to both BIS and Ramsay" Comment: Insufficient information to permit judgement of 'low risk' or 'high risk' |
| Allocation concealment (selection bias) | High risk | Comment: No information given about allocation concealment. Probably not done |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned, however not possible to blind in this type of study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | They were probably aware of the allocation, but review authors judge that the outcome reported is not likely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients completed the study and there was no loss to follow‐up |
| Selective reporting (reporting bias) | Unclear risk | No published protocol available, however all outcomes mentioned in the methods are reported |