A randomized, double-blind, placebo-controlled trial is currently underway to investigate the efficacy of dexmedetomidine nasal spray in reducing emergence agitation (EA) among adult patients undergoing ear, nose, and throat (ENT) surgery. The study, being conducted at the First Affiliated Hospital of Soochow University in China, aims to determine whether preoperative administration of dexmedetomidine can lead to a significant reduction in the incidence and severity of EA, a common post-anesthetic complication in ENT procedures.
Study Design and Objectives
The trial, registered at the Chinese Clinical Trial Registry (ChiCTR2400086731), involves 160 adult patients with ASA physical status I-III. Participants are randomly assigned to receive either 100 μg of dexmedetomidine nasal spray or a normal saline placebo approximately 30 minutes before anesthesia induction. The primary endpoint is the incidence of EA, defined as a Riker Sedation Agitation Scale (RSAS) score ≥5 from the discontinuation of sevoflurane until 5 minutes after tracheal extubation.
Secondary endpoints include the maximal RSAS score during emergence, the incidence of agitation in the post-anesthesia care unit (PACU), pain intensity, postoperative sleep disturbance, anxiety, and delirium within the first 24 hours postoperatively. Perioperative data such as hemodynamic parameters, depth of anesthesia, time to verbal response, and length of hospital stay will also be collected.
Methodology and Interventions
Patients receive standard anesthesia care, including intravenous dexamethasone, sufentanil, and propofol for induction, followed by sevoflurane and remifentanil for maintenance. Postoperative analgesia includes flurbiprofen axetil and sufentanil, with additional tramadol available upon request. Neuromuscular blockade is reversed with sugammadex. The emergence process is carefully monitored by investigators blinded to group allocation, with verbal stimuli used to arouse patients.
Expected Outcomes and Clinical Significance
The high incidence of EA in ENT surgery, ranging from 22% to 74%, can lead to complications such as postoperative bleeding, self-extubation, and increased healthcare costs. Dexmedetomidine, a selective α2 adrenergic agonist, has shown promise in preventing EA due to its sympatholytic, sedative, anxiolytic, and analgesic effects. Intranasal administration offers a non-invasive, convenient route with high bioavailability and patient acceptance.
Researchers hypothesize that preoperative dexmedetomidine nasal spray will reduce the incidence of EA and improve postoperative recovery. The study's findings could provide valuable insights into the use of dexmedetomidine nasal spray as a proactive measure to mitigate EA and enhance patient outcomes following ENT surgery. The results of the trial are expected by the end of 2024.
