Abdelgalel 2016.

Methods	Prospective, randomized, double‐blind controlled trial Setting: ICU Country: Egypt Groups: dexmedetomidine versus haloperidol versus saline infusion Period: January 2014 to October 2015
Participants	Sample size: 90 randomized (30/30/30) Included 18 years and older Need for non‐invasive ventilation (NIV) due to acute exacerbation of acute respiratory failure in chronic obstructive pulmonary disease (COPD) Acute hypoxaemic cardiogenic pulmonary oedema Postoperative respiratory failure Excluded Patient or relative refusal Allergy to study drugs Psychiatric disorders or on antipsychotic medications Severe dementia Heart rate ≤ 50 beats/minute Systolic blood pressure ≤ 90 mmHg Prolonged QTc time ( > 500 ms) History of clinically relevant ventricular arrhythmia Epilepsy Parkinsonism Pregnancy. Missing: none; all are accounted for in the flowchart.
Interventions	Patients were assigned in a 1:1:1 manner Intervention I: dexmedetomidine continuous intravenous infusion of 0.2 to 0.7 µg/kg/hour preceded by a loading dose of 1.0 µg/kg intravenously over 10 minutes if needed Intervention II: haloperidol continuous intravenous infusion of 0.5 to 2 mg/hour preceded by a loading dose of 2.5 mg intravenously over 10 minutes if needed Control: normal saline continuous intravenous infusion (2 to 8 mL/hour) and loading dose (10 mL) over 10 minutes if needed
Outcomes	Primary Incidence of delirium Secondary Duration of NIV Incidence of endotracheal intubation during NIV Length of ICU stay Length of hospital stay Adverse events and mortality Measured by: CAM‐ICU and RASS Adverse events: bradycardia occurred significantly more in dexmedetomidine group (8 patients) than in haloperidol group (2 patients) and placebo group (1 patient). 2 patients in haloperidol group developed prolonged QTc‐interval ( > 500 ms). No patients in both placebo and dexmedetomidine groups developed prolonged QTc interval. Three patients developed arrhythmia in haloperidol group compared to 2 patients in both dexmedetomidine and placebo groups. Hypotension occurred in 4 patients in dexmedetomidine group while hypotension occurred in 3 patients in both haloperidol and placebo groups.
Notes	Conclusion: incidence of delirium was significantly lower in dexmedetomidine group 3/30 (10%) than haloperidol 10/30 (33.3%) and placebo 13/30 (43.3%) groups. Duration of NIV was significantly shorter in dexmedetomidine group than in placebo group and haloperidol group. The incidence of endotracheal intubation was significantly less in dexmedetomidine group compared to placebo and haloperidol groups. The length of ICU and hospital stay was significantly shorter in dexmedetomidine group compared to the alternatives. Funding: not stated, untypical for a pharmacological study Conflict of interest: not declared, untypical for a pharmacological study Study number: not reported Contact with authors: author emailed 21 December 2016 for more information ‒ awaiting response
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No description of how the randomization was performed
Allocation concealment (selection bias)	Unclear risk	No description of how the allocation was concealed
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts
Selective reporting (reporting bias)	Unclear risk	No online protocol to check
Other bias	Unclear risk	Unknown other biases
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding of staff and patients
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinding of outcome assessor