Dexmedetomidine Nasal Spray on Emergence Agitation After Ear, Nose, and Throat Surgery: Protocol for a Randomized, Double-Blind, Controlled Trial

Background: Emergence agitation (EA) is a state of psychomotor hyperactivity following general anesthesia and is associated with postoperative complications. Patients undergoing ear, nose, and throat (ENT) surgery are at a high risk for EA. We aim to assess whether preoperative dexmedetomidine nasal spray reduces the occurrence of EA for patients undergoing ENT surgery.

Methods: This is a protocol for a randomized, double-blind, controlled trial that will include 160 adults scheduled for ENT surgery. Patients will be randomly assigned, in a 1:1 ratio, to receive dexmedetomidine nasal spray (100 μg) or a same volume of normal saline approximately 30 min before general anesthesia induction. The primary endpoint is the incidence of EA, defined as a Riker sedation agitation scale (RSAS) score ≥5 from discontinuation of sevoflurane until 5 min after tracheal extubation. Secondary endpoints include (1) the maximal RSAS score during emergence; (2) the incidence of agitation in the postoperative care unit (PACU); (3) pain at rest and while coughing in the PACU and at 24 h postoperatively; (4) postoperative sleep disturbance on the first night after surgery; (5) anxiety within 24 h postoperatively; and (6) postoperative delirium during the first 24 h after surgery. All analyses will be performed on a modified intention-to-treat basis. For the primary endpoint, subgroup analysis will be conducted on sex, age, and type of surgery.

Discussion: We expect that preoperative dexmedetomidine nasal spray would reduce the incidence of EA after ENT surgery. Our results offer clinical evidence for improving anesthetic care for patients undergoing ENT surgery.

Trial registration: Chinese Clinical Trial Registry (Identifier: ChiCTR2400086731).