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Efficacy of Single-Dose Dexmedetomidine Combined with Low-Dose Remifentanil Infusion for Cough Suppression Compared to High-Dose Remifentanil Infusion: A Randomized, Controlled, Non-Inferiority Trial.

ABSTRACT: Background: Combination of dexmedetomidine and opioid may be an alternative to high-dose opioid in attenuating cough during emergence from anesthesia, while also reducing the adverse effects of high-dose opioid. We tested the hypothesis that a single-dose of dexmedetomidine combined with low-dose remifentanil infusion during emergence would not be inferior to high-dose remifentanil infusion alone in attenuating cough after thyroidectomy. Methods: One hundred sixty-nine patients undergoing thyroidectomy were enrolled and randomized in a 1:1 ratio into group DR or group R. Each patient received an infusion of dexmedetomidine (0.5 ?g/kg) and low-dose remifentanil infusion of effect-site concentration (Ce) at 1 ng/mL or normal saline and high-dose remifentanil infusion of Ce at 2 ng/mL for 10 min at the end of surgery. Remifentanil was maintained until tracheal extubation. Primary endpoint was the severity of coughing, which was assessed for non-inferiority using a four-point scale at the time of extubation. For comparison of coughing incidence during emergence, coughing grade was also measured at three times: before extubation, at extubation, and after extubation. Time to awakening, hemodynamic and respiratory profile, pain, and postoperative nausea and vomiting were also evaluated for superiority. Results: The 95% confidence intervals for differences in cough grade during tracheal extubation were <0.9, indicating non-inferiority of the single dose of dexmedetomidine combined with low-dose remifentanil infusion. The incidence of coughing was similar in the two groups. Hemodynamic changes during tracheal extubation were attenuated, but emergence from anesthesia was delayed, in group DR. Use of rescue antiemetic was similar in both groups, but the incidence of vomiting was less in group DR. Conclusion: A single-dose of dexmedetomidine (0.5 ?g/kg) combined with low-dose remifentanil infusion at 1 ng/mL of Ce during emergence from sevoflurane-remifentanil anesthesia was not inferior to high-dose remifentanil infusion alone at 2 ng/mL of Ce with regard to suppressing cough.

SUBMITTER: Kim JH

PROVIDER: S-EPMC6428982 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Efficacy of Single-Dose Dexmedetomidine Combined with Low-Dose Remifentanil Infusion for Cough Suppression Compared to High-Dose Remifentanil Infusion: A Randomized, Controlled, Non-Inferiority Trial.

Kim Jae Hwan JH Ham Sung Yeon SY Kim Do-Hyeong DH Chang Chul Ho CH Lee Jeong Soo JS

International journal of medical sciences 20190124 3

<b>Background:</b> Combination of dexmedetomidine and opioid may be an alternative to high-dose opioid in attenuating cough during emergence from anesthesia, while also reducing the adverse effects of high-dose opioid. We tested the hypothesis that a single-dose of dexmedetomidine combined with low-dose remifentanil infusion during emergence would not be inferior to high-dose remifentanil infusion alone in attenuating cough after thyroidectomy. <b>Methods:</b> One hundred sixty-nine patients und ...[more]

PMID: 30911271

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Project description:BackgroundTo investigate the optimal dose of pretreated-dexmedetomidine in fentanyl-induced cough (FIC) suppression.MethodsPatients of 180 undergoing elective surgery with general anesthesia, aged 18-65 years, BMI 18.5-30 kg/m2, ASA I or II, were equally randomized into four groups (n = 45) to receive intravenous pretreatment of dexmedetomidine with 0 (group 1), 0.3 (group 2), 0.6 (group 3) and 0.9 (group 4) mcg/kg over 10 mins, respectively. After the pretreatment, all patients were given a 5-s intravenous injection of fentanyl 4 mcg/kg. The symptoms of irritating cough including the severity and onset time were recorded for 1 min after fentanyl injection. General anesthesia induction was completed with midazolam, propofol and cisatracurium, then endotracheal tube or laryngeal mask was inserted and connected to an anesthesia machine. MAP, HR and SpO2 at the beginning of pretreatment (T0), 3 min (T1), 6 min (T2), 9 min (T3) and 12 min (T4) after the beginning of pretreatment were recorded. Side effects of dexmedetomidine, such as bradycardia, hypertension, hypotension, and respiratory depression were also recorded during the course.ResultsTotally 168 patients completed the study. The incidences of cough were 52.4, 42.9, 11.9, and 14.3% in groups 1, 2, 3, and 4, respectively, with no significant differences between groups 1 and 2 (P > 0.05) and between groups 3 and 4 (P > 0.05). The incidence and severity of cough in groups 3 and 4 were significantly lower than those in groups 1 and 2 (P < 0.05). Compared to T0, HR at T2 (P < 0.05), T3 (P < 0.01), and T4 (P < 0.01) decreased significantly and MAP at T4 decreased significantly (P < 0.05) in group 4. Bradycardia occurred in 1 case and respiratory depression occurred in 1 case in group 4. Compared to group 1, the onset time of cough in the other 3 groups were delayed significantly (P < 0.05).ConclusionPretreated dexmedetomidine 0.6 mcg/kg blous intravenous infusion over 10 mins could reduce FIC effectively without side effects.Trial registrationThis study was registered in ClinicalTrials.gov (NCT03126422), April 13, 2017.

Project description:Only limited information exists on the pharmacokinetics of prolonged (> 24 hours) and high-dose dexmedetomidine infusions in critically ill patients. The aim of this study was to characterize the pharmacokinetics of long dexmedetomidine infusions and to assess the dose linearity of high doses. Additionally, we wanted to quantify for the first time in humans the concentrations of H-3, a practically inactive metabolite of dexmedetomidine.Thirteen intensive care patients with mean age of 57 years and Simplified Acute Physiology Score (SAPS) II score of 45 were included in the study. Dexmedetomidine infusion was commenced by using a constant infusion rate for the first 12 hours. After the first 12 hours, the infusion rate of dexmedetomidine was titrated between 0.1 and 2.5 ?g/kg/h by using predefined dose levels to maintain sedation in the range of 0 to -3 on the Richmond Agitation-Sedation Scale. Dexmedetomidine was continued as long as required to a maximum of 14 days. Plasma dexmedetomidine and H-3 metabolite concentrations were measured, and pharmacokinetic variables were calculated with standard noncompartmental methods. Safety and tolerability were assessed by adverse events, cardiovascular signs, and laboratory tests.The following geometric mean values (coefficient of variation) were calculated: length of infusion, 92 hours (117%); dexmedetomidine clearance, 39.7 L/h (41%); elimination half-life, 3.7 hours (38%); and volume of distribution during the elimination phase, 223 L (35%). Altogether, 116 steady-state concentrations were found in 12 subjects. The geometric mean value for clearance at steady state was 53.1 L/h (55%). A statistically significant linear relation (r2 = 0.95; P < 0.001) was found between the areas under the dexmedetomidine plasma concentration-time curves and cumulative doses of dexmedetomidine. The elimination half-life of H-3 was 9.1 hours (37%). The ratio of AUC0-? of H-3 metabolite to that of dexmedetomidine was 1.47 (105%), ranging from 0.29 to 4.4. The ratio was not statistically significantly related to the total dose of dexmedetomidine or the duration of the infusion.The results suggest linear pharmacokinetics of dexmedetomidine up to the dose of 2.5 ?g/kg/h. Despite the high dose and prolonged infusions, safety findings were as expected for dexmedetomidine and the patient population.ClinicalTrials.gov: NCT00747721.

Project description:Background and objectives: Flexible bronchoscopy has been widely used for diagnosis and intervention, while various drugs are used for sedation during bronchoscopy. We examined two regular standardized sedation options (with or without dexmedetomidine) regularly used in our regional hospital. The aim was to assess the efficacy and safety of dexmedetomidine on conscious sedation under bronchoscopy. Materials and Methods: A retrospective chart review was conducted from April 2017 to March 2018. All patients undergoing flexible bronchoscopy with moderate sedation were enrolled. Patients having received dexmedetomidine-propofol-fentanyl were defined as group D, and those having received midazolam-propofol-fentanyl were defined as group M. The primary outcome was a safety profile during the procedure, including the incidence of procedural interference by patient cough or movement, transient hypoxemia, and hypotension. The secondary outcome was measured by the recovery profile (awake and ambulation time). Results: Thirty-five patients in group D and thirty-three in group M were collected in this retrospective study. All patients underwent the procedure successfully. Group D showed higher safety with fewer procedural interference incidences by cough or body movement than Group M (3.3% versus 36.3%, p < 0.001) and minor respiratory adverse effects. Patients in group D showed faster recovery in a shorter ambulation time than group M (24.9 ± 9.7 versus 31.5 ± 11.9, p = 0.02). In group D, bronchoscopist satisfaction to sedation was higher than group M (p = 0.01). More transient bradycardia episodes were noted in patients receiving dexmedetomidine (p < 0.05), but all recovered without atropine intervention. Overall post-procedural adverse events and satisfaction were comparable in the two groups. Conclusions: The co-administration of dexmedetomidine met the safety and recovery demands of flexible bronchoscopy. Compared to the conventional midazolam-propofol-fentanyl regimen, the application of dexmedetomidine improved sedative effectiveness with less procedural interruptions, shorter time to ambulation and higher bronchoscopist satisfaction.

Dataset Information

Efficacy of Single-Dose Dexmedetomidine Combined with Low-Dose Remifentanil Infusion for Cough Suppression Compared to High-Dose Remifentanil Infusion: A Randomized, Controlled, Non-Inferiority Trial.

Publications

Efficacy of Single-Dose Dexmedetomidine Combined with Low-Dose Remifentanil Infusion for Cough Suppression Compared to High-Dose Remifentanil Infusion: A Randomized, Controlled, Non-Inferiority Trial.

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