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Dexmedetomidine versus midazolam on cough and recovery quality after partial and total laryngectomy - a randomized controlled trial.

ABSTRACT: BACKGROUND:During emergence from anesthesia after partial and total laryngectomy, excessive airway reflex and systemic hypertension may lead to subcutaneous emphysema, hemorrhage or pneumothorax. METHODS:American Society of Anesthesiologist physical status III and IV male adults undergoing elective laryngectomy were recruited and randomly allocated to receive either dexmedetomidine (group D) or midazolam (group M). The primary outcome was incidence and severity of cough. Pulse oximetry results (SpO2), heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) were also recorded. The visual analog scale and the Ramsay sedation scale were recorded at the points of wakefulness and departure from the post-anesthesia care unit (PACU). Rescue analgesia consumption, the time of spontaneous breath recovery, duration of the PACU stay, and the incidence of adverse effects were also recorded. RESULTS:The prevalence of no coughing was significantly higher in group D than in group M at the points of wakefulness and departure. HR, SBP, and DBP were significantly lower in group D compared with group M, and SpO2 was significantly higher in group D than in group M at the moment of laryngectomy. Pain scores were lower in group D than in group M. The Ramsay score at the point of wakefulness was higher in group D than in group M. There was no difference in time to spontaneous breathing recovery, duration of the PACU stay, and incidence of adverse effects. CONCLUSIONS:Compared with midazolam, dexmedetomidine is an effective alternative to attenuate coughing and hemodynamic changes with a low incidence of adverse events during emergence from anesthesia after partial and total laryngectomy. TRIAL REGISTRATION:NCT03918889 , registered at clinicaltrials.gov, date of registration: March 28, 2019.

SUBMITTER: Xu R

PROVIDER: S-EPMC7523379 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Dexmedetomidine versus midazolam on cough and recovery quality after partial and total laryngectomy - a randomized controlled trial.

Xu Rui R Zhu Yun Y Lu Yi Y Li Wenxian W Jia Jie J

BMC anesthesiology 20200928 1

<h4>Background</h4>During emergence from anesthesia after partial and total laryngectomy, excessive airway reflex and systemic hypertension may lead to subcutaneous emphysema, hemorrhage or pneumothorax.<h4>Methods</h4>American Society of Anesthesiologist physical status III and IV male adults undergoing elective laryngectomy were recruited and randomly allocated to receive either dexmedetomidine (group D) or midazolam (group M). The primary outcome was incidence and severity of cough. Pulse oxi ...[more]

PMID: 32988369

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Project description:Dexmedetomidine as a sole agent showed limited use for painful procedures due to its insufficient sedative/analgesic effect, pronounced hemodynamic instability and prolonged recovery. The aim of this study was to compare the effects of dexmedetomidine-ketamine (DK) versus dexmedetomidine-midazolam-fentanyl (DMF) combination on the quality of sedation/analgesia and recovery profiles for monitored anesthesia care (MAC).Fifty six patients undergoing chemoport insertion were randomly assigned to group DK or DMF. All patients received 1 μg.kg(-1) dexmedetomidine over 10 min followed by 0.2-1.0 μg.kg(-1)h(-1) in order to maintain 3 or 4 of modified Observer's Assessment of Analgesia and Sedation score checked every 3 min. At the start of dexmedetomidine infusion, patients in group DK or DMF received 0.5 mg.kg(-1) ketamine or 0.05 mg.kg(-1) midazolam + 0.5 μg.kg(-1) fentanyl intravenously, respectively. When required, rescue sedatives (0.5 mg.kg-1 of ketamine or 0.05 mg.kg-1 of midazolam) and analgesics (0.5 mg.kg-1 of ketamine or 0.5 μg.kg-1 of fentanyl) were given to the patients in DK or DMF group, respectively. The primary outcome of this study was the recovery parameters (time to spontaneous eye opening and the length of the recovery room stay). The secondary outcomes were parameters indicating quality of sedation/analgesia, cardiorespiratory variables, and satisfaction scores.There were no significant differences in the onset time, time to spontaneous eye opening, recovery room stay, the incidences of inadequate analgesia, hypotension and bradycardia between the two groups. Despite lower infusion rate of dexmedetomidine, more patients in the DMF group had bispectral index (BIS) < 60 than in the DK group and vice versa for need of rescue sedatives. The satisfaction scores of patients, surgeon, and anesthesiologist in the DMF group were significantly better than the DK group.The DK and DMF groups showed comparable recovery time, onset time, cardiorespiratory variables, and analgesia. However, the DMF group showed a better sedation quality and satisfaction scores despite the lower infusion rate of dexmedetomidine, and a higher incidence of BIS < 60 than the DK group.Clinical Trial Registry of Korea KCT0000951 , registered 12/12/2013.

Project description:Dexmedetomidine was shown in two European randomized double-blind double-dummy trials (PRODEX and MIDEX) to be non-inferior to propofol and midazolam in maintaining target sedation levels in mechanically ventilated intensive care unit (ICU) patients. Additionally, dexmedetomidine shortened the time to extubation versus both standard sedatives, suggesting that it may reduce ICU resource needs and thus lower ICU costs. Considering resource utilization data from these two trials, we performed a secondary, cost-minimization analysis assessing the economics of dexmedetomidine versus standard care sedation.The total ICU costs associated with each study sedative were calculated on the basis of total study sedative consumption and the number of days patients remained intubated, required non-invasive ventilation, or required ICU care without mechanical ventilation. The daily unit costs for these three consecutive ICU periods were set to decline toward discharge, reflecting the observed reduction in mean daily Therapeutic Intervention Scoring System (TISS) points between the periods. A number of additional sensitivity analyses were performed, including one in which the total ICU costs were based on the cumulative sum of daily TISS points over the ICU period, and two further scenarios, with declining direct variable daily costs only.Based on pooled data from both trials, sedation with dexmedetomidine resulted in lower total ICU costs than using the standard sedatives, with a difference of €2,656 in the median (interquartile range) total ICU costs-€11,864 (€7,070 to €23,457) versus €14,520 (€7,871 to €26,254)-and €1,649 in the mean total ICU costs. The median (mean) total ICU costs with dexmedetomidine compared with those of propofol or midazolam were €1,292 (€747) and €3,573 (€2,536) lower, respectively. The result was robust, indicating lower costs with dexmedetomidine in all sensitivity analyses, including those in which only direct variable ICU costs were considered. The likelihood of dexmedetomidine resulting in lower total ICU costs compared with pooled standard care was 91.0% (72.4% versus propofol and 98.0% versus midazolam).From an economic point of view, dexmedetomidine appears to be a preferable option compared with standard sedatives for providing light to moderate ICU sedation exceeding 24 hours. The savings potential results primarily from shorter time to extubation.ClinicalTrials.gov NCT00479661 (PRODEX), NCT00481312 (MIDEX).

Project description:BACKGROUND:To investigate the optimal dose of pretreated-dexmedetomidine in fentanyl-induced cough (FIC) suppression. METHODS:Patients 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. RESULTS:Totally 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). CONCLUSION:Pretreated dexmedetomidine 0.6 mcg/kg blous intravenous infusion over 10 mins could reduce FIC effectively without side effects. TRIAL REGISTRATION:This study was registered in ClinicalTrials.gov (NCT03126422), April 13, 2017.

Project description:BACKGROUND: In this study, we aim to gather information about the quality of life issues, functional outcomes and voice problems facing early glottic cancer patients treated with the surgical techniques such as laryngofissure cordectomy, fronto-lateral laryngectomy, or cricohyoidopexi. In particular, consistency of life and voice quality issues with the laryngeal tissue excised during surgery is examined. In addition, the effects of arytenoidectomy to the life and voice quality are also studied. METHODS: 29 male patients were enrolled voluntarily in the study. The average age was 53.9 years. Three out of 10 patients with laryngofissure cordectomy also had arytenoidectomy. 11 patients had fronto-lateral laryngectomy with Tucker reconstruction, two of which also had arytenoidectomy. There were eight patients with cricohyoidopexi and bilateral functional neck dissection. Three of these patients also had arytenoidectomy. In bilateral functional neck dissection cases, spinal accessory nerve was preserved and level V of the neck was not dissected. None of the patients had neither radiotherapy nor voice therapy. Cordectomy patients never had a temporary tracheotomy or were connected to a feeding tube. Data was collected for 13 months for the cordectomy group, 14 months for fronto-lateral laryngectomy and cricohyoidopexi groups on average post-operatively. Statistical analysis in this study was carried out using the one-way analysis of variance, and the Post-Hoc group comparisons were made after Bonferroni and Scheffe-procedures.In order to determine the effects of arytenoidectomy, a regression analysis is carried out to see if there are statistical differences in answers given to the survey questions among patients who were arytenoidectomized during their surgeries. RESULTS: There was a statistically significant difference between cordectomy and cricohyoidopexi group in answers to the University of Washington- Quality of Life- Revised survey part 1. (p = 0). A statistically significant difference was also established between cordectomy and fronto-lateral laryngectomy groups, as well as between cordectomy and cricohyoidopexi groups in answers to the University of Washington- Quality of Life- Revised survey part 2. (p = 0,036 and p = 0.009, respectively). Cricohyoidopexi group has given the lowest scores and the cordectomy group has given the highest scores in three survey questions representing the quality of life, performances and new voices. These ranges are also consistent with the laryngeal tissue excised during surgery (cricohyoidopexi > fronto-lateral laryngectomy > cordectomy). There was no statistically significant difference between groups in Performance Status Scale for Head and Neck cancer patients instrument. The difference between the Voice Handicap Index and Voice Handicap Index (functional); Voice Handicap Index (physical) and Voice Handicap Index (emotional) scores in three patient groups was not significant either. All of the patients evaluated that their new voices have similar functional, physical and emotional impact on their life. Decanulation and oral feeding times of cricohyoidopexi and fronto-lateral laryngectomy patients are found to be significantly longer than cordectomy patients. Lastly, the removal of arytenoid does not have any significant adverse effects on the quality of life, the functional outcomes, or the quality of voice. CONCLUSION: In the present study, all patients with early glottic cancer, treated with different surgical technics reported fairly good quality of life outcomes, functional results and voice qualities. This study also finds that the removal of arytenoid does not have any adverse effects on the quality of life and voice from the patients' point of view.

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Dexmedetomidine versus midazolam on cough and recovery quality after partial and total laryngectomy - a randomized controlled trial.

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Dexmedetomidine versus midazolam on cough and recovery quality after partial and total laryngectomy - a randomized controlled trial.

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