Introduction
Emergence agitation (EA) represents a temporary but distressing state that can occur during the recovery phase from general anesthesia, characterized by behaviors such as psychomotor agitation, overwhelming restlessness, hyperactivity, disorientation, and perceptual disturbances.1 Various factors have been identified as potential contributors to EA, including male gender, younger age, the type and duration of surgical procedures, the administration of benzodiazepines, and the level of postoperative pain experienced by patients.1,2 Specifically for individuals undergoing ear, nose, and throat (ENT) surgical interventions, the occurrence of EA can be alarmingly high, with reported incidences ranging from 22% to 74%.3–6 This phenomenon can result in significant clinical implications, including risks such as postoperative bleeding, unintended self-extubation, removal of critical catheters, and even patient injuries, along with soaring healthcare costs.7–9
Research indicates that the administration of α2 adrenoreceptor agonists, along with adjuncts such as magnesium sulfate, ketamine, and multimodal analgesia, may provide effective preventative measures against EA.1 Among these, dexmedetomidine stands out as a selective α2 agonist known for its sympatholytic, sedative, anxiolytic, and analgesic attributes. Continuous infusion of dexmedetomidine during the intraoperative period has demonstrated the ability to stabilize hemodynamic parameters and ensure a smoother emergence from anesthesia for patients undergoing nasal surgeries.10 The non-invasive nature of intranasal administration results in superior bioavailability while effectively bypassing the discomfort often associated with intravenous venipuncture.11 The use of dexmedetomidine through nasal spray has been noted for its simplicity and significant patient comfort levels.12 Both children and adults undergoing surgical procedures have reported safe and satisfactory sedation with intranasal dexmedetomidine.13–15 However, the efficacy of dexmedetomidine nasal spray in mitigating EA following ENT surgeries remains to be conclusively established.
In this randomized controlled trial, our objective is to investigate the impact of dexmedetomidine nasal spray on both the frequency and severity of EA in patients scheduled for ENT surgical procedures. Furthermore, we will assess postoperative pain levels, quality of sleep, levels of anxiety, and the incidence of delirium within the postoperative period across both study groups.
Methods
Ethics and Registration
The trial protocol received ethical approval from the Ethics Committee of The First Affiliated Hospital of Soochow University (Approval No. 2024–200) on June 12, 2024. Registration of this trial has been carried out with the Chinese Clinical Trial Registry (identifier: ChiCTR2400086731) on July 9, 2024. This study will adhere strictly to the principles outlined in the Declaration of Helsinki. Informed written consent will be obtained from all participating patients. The study protocol conforms to the guidelines set forth by the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (Table S1).16
Study Design and Status
This study is an investigator-initiated, single-center, randomized, double-blind, placebo-controlled trial designed with a parallel-group superiority approach. We anticipate enrolling a total of 160 adult patients who are preparing for ENT surgeries at the First Affiliated Hospital of Soochow University, located in Suzhou, China. The enrollment of the initial participant commenced on June 15, 2024, and recruitment efforts remain active as of this protocol’s submission. We aim to complete participant enrollment by the end of December 2024. Figure 1 visually depicts the study flowchart. Table 1 outlines the timeline for patient enrollment, the interventions administered, and the measurements to be collected in accordance with the SPIRIT guidelines.
Randomization and Blinding
The randomization sequence will be developed by an independent statistician using an online tool (https://www.sealedenvelope.com/randomisation/) applying a 1:1 ratio and block sizes of both 2 and 4. The allocation details will be secured in opaque envelopes to preserve confidentiality. A research nurse not involved in any subsequent study procedures will randomly assign patients either to the dexmedetomidine group or to a normal saline group. This nurse will also prepare identical nasal spray bottles containing either dexmedetomidine or a normal saline placebo. Both substances will appear as clear, colorless fluids, masking their true nature. All patients as well as researchers responsible for data collection and evaluation of outcomes will remain blind to the group assignments. The anesthesia team may be exposed to group identifiers during the anesthesia induction phase due to the sedative properties of dexmedetomidine; however, the core hypothesis of this study will remain undisclosed. Following surgery, two investigators unaware of the group allocations will supervise the emergence process and evaluate the presence of EA.
Study Interventions and Anesthesia
In the preoperative waiting area, patients will receive either 100 µg dexmedetomidine or normal saline via nasal spray approximately half an hour prior to anesthesia induction. Proper nostril cleaning and specific head tilting instructions will be given to the patients before the administration, which will involve two sprays into both nostrils within a two-minute timeframe. Heart rate and other vital signs will be closely monitored throughout the procedure using Bispectral Index (BIS; Medtronic, Minneapolis, MN, USA) monitors starting from the nasal spray administration until departure from the operating room.
Patients will undergo peripheral vein cannulation and standard monitoring including cuff blood pressure, electrocardiography, pulse oximetry, and end-tidal carbon dioxide during the operation. Anesthesia induction will consist of intravenous administration of dexamethasone (5 mg), sufentanil (0.2–0.4 µg/kg), and propofol (1.5–2 mg/kg). Following this, rocuronium (0.6–0.8 mg/kg) will be given to facilitate tracheal intubation. Anesthesia maintenance will be achieved through inhalation of 1–3% sevoflurane, keeping BIS values within the range of 40–60. Throughout the surgery, remifentanil will infuse at a rate of 0.05–0.2 µg/kg/min. Patients will also receive palonosetron (0.25 mg) for the prevention of postoperative nausea and vomiting. At the conclusion of surgery, sevoflurane and remifentanil will be discontinued, with postoperative analgesia being provided through intravenous flurbiprofen axetil (50 mg) and sufentanil (0.1 µg/kg). Additional analgesics like tramadol (50-100 mg) can be administered as needed.
All patients will receive sugammadex (2 mg/kg) to immediately reverse neuromuscular blockade following anesthesia completion. During the emergence phase, verbal stimuli will be utilized for arousal every 30 seconds. Patients will be prompted with “(Patient’s name), please open your eyes!” at a conversational volume, while avoiding any physical stimulation. Tracheal extubation will occur in the operating room. Post-extubation, patients will be moved to the post-anesthesia care unit (PACU) and monitored. A modified Aldrete score of 9 or higher will signify the readiness for discharge from the PACU to surgical wards.17
Primary Endpoint
The primary objective of this study is to evaluate the incidence of EA, defined as a Riker Sedation Agitation Scale (RSAS) score of 5 or higher from the cessation of sevoflurane until five minutes after tracheal extubation within the operating room.3 Two independent investigators, who remain blinded to group assignments, will verify the occurrence and severity of EA through consensus.
RSAS scores range from 1 to 7, capturing a spectrum from unarousable at score 1 to dangerous agitation at score 7.18
Secondary Endpoints
A range of secondary endpoints will be assessed, including: (1) the highest RSAS score recorded during emergence; (2) the occurrence of agitation within the PACU (indicated by RSAS scores ≥ 5); (3) pain intensity assessment both at rest and during coughing in the PACU, as well as at 24 hours postoperatively; (4) the presence of postoperative sleep disturbances on the first night following surgery; (5) the incidence of anxiety within 24 hours post-surgery; and (6) the evaluation of postoperative delirium within the initial 24 hours post-surgery.
Pain intensity will be measured using the numerical rating scale (NRS), extending from 0 (no pain) to 10 (worst pain imaginable). Quality of sleep will be assessed using the Athens Insomnia Scale, with scores ranging from 0 to 24. A score of 6 or higher indicates the presence of postoperative sleep disturbances.19 The Hospital Anxiety and Depression Scale-Anxiety subscale will evaluate anxiety with a score range of 0-21, with a score of 8 or above indicating significant anxiety.20 The occurrence of postoperative delirium will be monitored using the 3-Minute Diagnostic Confusion Assessment Method administered at designated times on postoperative day 1.21
Perioperative Non-Endpoint Data
Venipuncture pain experienced prior to anesthesia induction will be quantified via the NRS. Hemodynamic metrics including mean blood pressure and heart rate will be recorded at multiple time points: baseline, immediately preceding induction, post-tracheal intubation, after sevoflurane discontinuation, following verbal response, at extubation, and upon discharge from the operating room. Additionally, depth of anesthesia will be assessed through BIS values at those aforementioned time points. Other perioperative data will capture the time to verbal response, time to extubation, duration until operating room discharge, length of PACU stay, postoperative hospitalization duration, requirements for additional analgesics, occurrence of adverse events, and significant postoperative complications (Table S2). Satisfaction ratings will be collected at 48 hours post-surgery utilizing a 5-point Likert scale (1 being “very dissatisfied” and 5 being “very satisfied”).
Data Collection and Monitoring
The day prior to surgery, a dedicated research assistant will conduct screening for eligible participants and gather baseline data. Secondary perioperative non-endpoint data will be accessed through the electronic anesthesia monitoring system, in conjunction with ward visits or telephone follow-ups. The primary and secondary endpoint data will be collected by investigators who are blinded to group assignments. Comprehensive data will be systematically recorded in case report forms and subsequently entered into an electronic database, with oversight from the principal investigator. Upon completion of data gathering, the database will be locked. Anonymized datasets devoid of any personal patient identifiers will be forwarded to an independent statistician for analysis based on the predetermined statistical plan. An external data monitoring committee will ensure rigorous compliance throughout the data collection, registration, and analysis stages.
Sample Size Calculation
Existing literature highlights that the typical incidence of EA following ENT surgery stands at 55.4%.3,4 We hypothesize that the introduction of dexmedetomidine nasal spray could lower the incidence rate to approximately 33.2%. To adequately assess the differences between the groups, a requirement of 75 patients in each group is established based on an α significance level of 0.05 and a statistical power of 80%. Anticipating potential dropouts, we aim to enroll a total of 160 patients (80 per group). The statistical calculations were performed using PASS software (version 15.0.5, NCSS, LCC, Kaysville, UT, USA).
Statistical Analysis
Continuous variables will be characterized as means (with standard deviations) or medians (accompanied by interquartile ranges) depending on the distribution of the data. Categorical data will be presented as counts (%). Comparative analyses will utilize independent t tests, Mann–Whitney rank-sum tests, Chi-squared tests, or Fisher’s exact tests as appropriate. For the evaluation of the primary and secondary endpoints, differences between groups will be examined utilizing relative risk metrics and differences in means or medians, along with their corresponding 95% confidence intervals. Furthermore, a predefined subgroup analysis will scrutinize the primary endpoint according to gender (male, female), age brackets (≤30 years or >30 years), and surgical type (ear, nose, or throat). An interaction analysis will also be performed, and results from the subgroup analysis will be presented using a forest plot.
All statistical evaluations will be executed on a modified intention-to-treat principle, encompassing all patients who underwent randomization and possess outcome data. We expect that the incidence of missing data will be minimal; therefore, no imputation strategies will be applied. An independent statistician will conduct the analysis using SPSS software (version 25.0; IBM SPSS, Chicago, IL, USA). A two-sided P value will be used to assess significance.
Discussion
This randomized, double-blind, controlled trial will enroll 160 adult patients scheduled for ENT surgical procedures to comprehensively evaluate the effects of dexmedetomidine nasal spray compared to a normal saline placebo on the incidence and severity of EA. Moreover, postoperative assessments will encompass pain levels, sleep quality, anxiety experiences, and incidences of delirium within the first 24 hours post-surgery. Our principal hypothesis revolves around the expectation that preoperative dexmedetomidine nasal spray administration will significantly diminish EA occurrences in patients recovering from ENT surgeries. The execution of this trial, along with the subsequent reporting of findings, will conform to the Consolidated Standards of Reporting Trials guidelines.22
Postoperative sleep quality during the initial night and anxiety levels within the first 24 hours after surgery represent important secondary endpoints. Frequently, patients undergoing ENT surgeries face discomfort and heightened anxiety throughout the initial postoperative night, severely impacting sleep quality. If left unresolved, postoperative sleep disturbances may detrimentally affect cognitive functioning, delay recovery timelines, and even elevate cardiovascular risks.27 Notably, dexmedetomidine sets itself apart from conventional sedatives by inducing a sedative state that closely mirrors natural sleep while upholding respiratory stability.28
This study is not without its limitations. Firstly, it is confined to a single center, which may limit the applicability of findings to other healthcare settings. Additionally, the protocol specifies only a single intranasal dose of 100 μg of dexmedetomidine, and future investigations are required to elucidate the optimal dosing strategies for dexmedetomidine nasal sprays. Lastly, due to the heightened EA risk among ENT surgery patients, our trial exclusively includes this demographic; patients undergoing alternative surgeries might also yield favorable responses to dexmedetomidine nasal spray therapy, which remains to be clarified by forthcoming research.
In summary, this randomized clinical trial is meticulously designed to assess the specific effects of dexmedetomidine nasal spray on the prevalence of EA in adults undergoing ENT surgical operations. Our hypothesis posits that the use of intranasal dexmedetomidine will lead to significant reductions in EA rates, thereby enhancing the overall postoperative recovery trajectories following these critical ENT interventions.
Data Sharing Statement
Data will be made available on request.
Funding
This work will be supported by National Natural Science Foundation of China (82471290 to KP), Suzhou Medical Health Science and Technology Innovation Project (SKY2022136 to KP), Postgraduate Research & Practice Innovation Program of The First Affiliated Hospital of Soochow University (RSJCX202408 to MYZ), Key Medical Research Projects in Jiangsu Province (ZD2022021 to FHJ), and Suzhou Clinical Medical Center for Anesthesiology (Szlcyxzxj202102 to FHJ).
Disclosure
The authors have no conflicts of interest to declare in this work.
References
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9. Marcantonio ER. Delirium in hospitalized older adults. N Engl J Med. 2017;377(15):1456–1466. doi:10.1056/NEJMcp1605501
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11. Fortuna A, Alves G, Serralheiro A, Sousa J, Falcão A. Intranasal delivery of systemic-acting drugs: small-molecules and biomacromolecules. Eur J Pharm Biopharm. 2014;88(1):8–27. doi:10.1016/j.ejpb.2014.03.004
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13. Shen F, Zhang Q, Xu Y, et al. Effect of intranasal dexmedetomidine or midazolam for premedication on the occurrence of respiratory adverse events in children undergoing tonsillectomy and adenoidectomy: a randomized clinical trial. JAMA Network Open. 2022;5(8):e2225473. doi:10.1001/jamanetworkopen.2022.25473
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Introduction
Ah, emergence agitation (EA). It sounds like a modern art exhibit, doesn’t it? Well, it’s quite the opposite—a chaotic state of restlessness, confusion, and downright Bizarro World behavior that can occur after the blissful escape of general anesthesia. You know the one—like when you wake up from a nap and forget where you left your coffee. EA can have serious implications, especially for our friends in the ENT surgery wing, with incidence rates being as wild as 22% to 74%. Talk about a rollercoaster! Not only does it cause distress to patients, but it can lead to everything from self-extubation (which sounds about as fun as a root canal) to bruising hospital budgets with increased healthcare costs.
Researchers have thrown a spotlight on factors like male sex, younger age, and the use of certain medications that seem to lay the groundwork for EA to rear its ugly head. But fear not! They suggest treatments with α2 adrenoreceptor agonists and magnesium sulfate among others. Enter dexmedetomidine—a star player that promises stability and calm within the surgical storm.
Methods
Ethics and Registration
Now, before you think this is just a free-for-all experiment, hold your horses! Ethics committees are involved, and consent will be collected. The whole shebang is registered properly—thank goodness we’re not sprinting into the abyss without any paperwork in place. This isn’t your average dinner party; it’s surgery we’re talking about, and safety comes first!
Study Design and Status
This is a single-center, double-blind, randomized controlled trial. It sounds fancy, but really, it just means they’re taking surgery seriously with a hefty dose of scientific rigor. The plan is to enroll 160 adults undergoing ENT surgeries—so if you’re a curious cat, be ready to have your nose (or ears) probed. Recruitment is ongoing, and you know what they say: ‘Good things come to those who wait!’ But let’s hope it’s just dexmedetomidine they’re waiting for and not a sequel to Waiting for Godot.
Eligibility Criteria
Anyone 18 or older, healthy enough to qualify, and brave enough to go under the knife can join the fun. But if you’ve got a history of mental battles that could affect your emergence from anesthesia, you’re out. Sorry, no drama queens allowed!
Randomization and Blinding
The randomization sequences are more tightly secured than a magician’s tricks—sealed envelopes, independent statisticians, and a 1:1 ratio that makes your head spin faster than a night out at the pub. And, in case you’re betting on which group gets the dexmedetomidine, it’s a secret! Everyone involved will be blissfully unaware until the grand reveal post-surgery. Sounds thrilling, doesn’t it?
Study Interventions and Anesthesia
Patients will receive either the dexmedetomidine nasal spray or just saline—a little placebo magic to keep things interesting. Here’s the kicker: this is done while they’re seated, nostrils prepped and ready! And when it’s showtime in the operating room? They’ll be pampered with the finest anesthesia mix, designed to keep them stable and hopefully calm down any inward dragons that may arise.
Primary Endpoint
The aim is to see if dexmedetomidine nasal spray can keep EA at bay. They’ve got a scale for that (the Riker Sedation Agitation Scale) that’s like a mood ring for post-anesthesia patients, ranging from serene to a scene from Jaws. If they hit a score of 5 or higher, we’ve got agitation on our hands, which not even a caffeinated cup of tea can fix.
Secondary Endpoints
But wait, there’s more! The researchers are also tracking post-op pain levels, sleep quality (because nobody wants that early morning grumpiness at 2 AM), anxiety, and delirium. Get your sleep masks ready, folks—there are many layers to this surgical onion!
Data Collection and Monitoring
This process is as organized as a Tetris game—data will be meticulously collected and analyzed while ensuring the anonymity of our brave surgery volunteers. With high-tech monitoring and strict oversight, it promises to be a well oiled machine—unless someone steps on a Lego, and we all know how that goes!
Discussion
Your typical March Madness basketball team has nothing on the complexity of this trial. With 160 subjects and a grand prize of measurable post-operative relief, the stakes have never been higher! If dexmedetomidine nasal spray does deliver on its promises, expect to see fewer agitated patients and a return to regular programming (or sleep) shortly after surgery. However, don’t hold your breath—this is science, not magic!
In case you were wondering, yes, there are limitations. For starters, it’s a single-center trial, so don’t expect the whole world of surgical patients to benefit just yet. And only a specific group of surgery patients are included, which narrows our horizons for now. But hey, who doesn’t love a cliffhanger?
In wrapping it all up, this trial is expected to produce results that could redefine patient recovery paths post-ENT surgery. Keep your fingers crossed; we might just witness the dawn of a calmer, more peaceful emergence from anesthesia!
Data Sharing Statement
For those itching to dive into the nitty-gritty numbers, rest assured data will be made available upon request. Don’t forget your coffee, though—this is serious business!
Author Contributions
What do you get when you mix rigorous research with dedicated authors? A recipe for success—a smiling team that’s crafted this masterpiece with care. Kudos to them.
Funding
This work is receiving some hefty financial backing from various foundations across China. They mean business when it comes to funding research that could enhance surgical recovery protocols. Let’s just hope they’re not working off of Monopoly money!
Disclosure
No conflicts of interest are reported—a nice breath of fresh air amid potentially murky waters!
References
…[The extensive list of citations follows, providing depth and backing the claims made throughout the study. We owe so much to the previous literature that lays the foundation for today’s research efforts!]…
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