Intranasal Dexmedetomidine in Elderly Patients (Aged > 65 Years) During Maxillofacial Surgery: Sedative Properties and Safety Analysis.

PURPOSE: Light sedation rather than intravenous sedation is preferred when patients have a low heart rate and blood pressure during maxillofacial surgery. Intranasal administration of dexmedetomidine is reported to be efficacious and safe in adults. However, dexmedetomidine could be unsuitable for routine clinical use in elderly patients because many of these patients take ß-blockers, which increase the cardiovascular effects of dexmedetomidine. The objectives of the study were to evaluate the sedative properties and safety of intranasal dexmedetomidine, regardless of concurrent ß-blocker treatment, in elderly patients who underwent maxillofacial surgery. METHODS: This study was a retrospective analysis of 535 patients aged > 65 years (American Society of Anesthesiologists physical status I or II) who were undergoing maxillofacial surgery. Very anxious patients and those with hypertension received intranasal 1 µg/kg dexmedetomidine through an intranasal mucosal atomization device before anesthesia (local ropivacaine). RESULTS: Intranasal administration of dexmedetomidine decreased the requirement for midazolam before surgery (18 of 252 vs 63 of 283, P < .0001), but increased the requirement for norepinephrine (102 of 252 vs 8 of 283, P < .0001) during or after the surgery. A combination of a ß-blocker and intranasal administration of dexmedetomidine reduced the hemodynamic parameters for an extended period. Intranasal administration of dexmedetomidine resulted in bradycardia and hypotension, regardless of concurrent ß-blocker treatment. CONCLUSIONS: Intranasal 1 µg/kg dexmedetomidine was associated with a high sedation score during the operation, but also with bradycardia and hypotension.

[A multicenter, randomized, controlled, phase â ¢ clinical study of PEG-rhG-CSF for preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer].

OBJECTIVE: To explore the safety and efficacy of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer (NSCLC), and to provide the basis for clinical application. METHODS: According to the principle of open-label, randomized, parallel-group controlled clinical trial, all patients were randomized by 1∶1∶1 into three groups to receive PEG-rhG-CSF 100 µg/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 µg/kg, respectively. The patients with breast cancer received two chemotherapy cycles, and the NSCLC patients received 1-2 cycles of chemotherapy according to their condition. All patients were treated with the combination chemotherapy of TAC (docetaxel+ epirubicin+ cyclophosphamide) or TA (docetaxel+ epirubicin), or the chemotherapy of docetaxel combined with carboplatin, with a 21 day cycle. RESULTS: The duration of grade 3-4 neutropenia in the PEG-rhG-CSF 100 µg/kg and PEG-rhG-CSF 6 mg groups were similar with that in the rhG-CSF 5 µg/kg group (P>0.05 for all). The incidence rate of grade 3-4 neutropenia in the PEG-rhG-CSF 100 µg/kg group, PEG-rhG-CSF 6 mg group, and G-CSF 5 µg/kg group were 69.7%, 68.4%, and 69.5%, respectively, with a non-significant difference among the three groups (P=0.963). The incidence rate of febrile neutropenia in the PEG-rhG-CSF 100 µg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 µg/kg group were 6.1%, 6.4%, and 5.5%, respectively, showing no significant difference among them (P=0.935). The incidence rate of adverse events in the PEG-rhG-CSF 100 µg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 µg / kg group were 6.7%, 4.1%, and 5.5%, respectively, showing a non-significant difference among them (P=0.581). CONCLUSIONS: In patients with breast cancer and non-small cell lung cancer (NSCLC) undergoing TAC/TA chemotherapy, a single 100 µg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF at 48 hours after chemotherapy show definite therapeutic effect with a low incidence of adverse events and mild adverse reactions. Compared with the continuous daily injection of rhG-CSF 5 µg/kg/d, a single 100 µg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF has similar effect and is more advantageous in preventing chemotherapy-induced neutropenia.