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Clinical Trial Summary

Background: During emergence from anesthesia for partial and total laryngectomy, severe airway reflex and systemic hypertension during recovery may lead to pneumoderm, hemorrhage, pneumomediastinum or pneumothorax. Dexmedetomidine is a selective α2-adrenoreceptor agonist that has sedative, analgesic, and sympatholytic properties. It has been reported dexmedetomidine can attenuate coughing reflex and prevent emergence agitation without delaying recovery and respiratory depression from general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine compared with midazolam on cough suppression and recovery quality during emergence from general anesthesia after partial and total laryngectomy.

Methods American Society of Anesthesiologists physical status I-II male adults undergoing elective laryngectomy under sevoflurane anesthesia were recruiting and randomly allocated to receive either dexmedetomidine(Group D, n = 60) infusion at 0.5 µg•kg−1 for 10 min before tracheotomy, then adjusted to 0.3µg•kg−1•h−1 or midazolam (Group M, n = 60) infusion at 0.05 mg•kg−1 ten minutes before tracheotomy, then adjusted to 0.02mg•kg−1•h−1. The primary outcome measure was the incidence and severity of cough. Hemodynamics, pain intensity [Visual Analogue Scale (VAS)] and Ramsay sedation scale (RSS) were also evaluated at awake, patients returning to ward from post anesthesia care unit (PACU),2h after surgery. postoperative sufentanil consumption, recovery time and the incidence of concerning adverse effects were recorded.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT03918889
Study type Interventional
Source Eye & ENT Hospital of Fudan University
Contact
Status Enrolling by invitation
Phase N/A
Start date May 1, 2019
Completion date December 1, 2020

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