[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07709390":3,"trial-entities:NCT07709390":90,"trial-summary:NCT07709390":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":43,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":63,"locations":66,"central_contacts":84,"overall_officials":87,"references":88,"see_also_links":89},"NCT07709390","STUDY20260673","ENDOTRACHEAL Tube LIDOCAINE","Application of a 5% Lidocaine Ointment to Endotracheal Tubes to Reduce Emergence Bucking: a Randomized Double-Blind Prospective Trial.","NOT_YET_RECRUITING","2029-01-31","2026-07","2026-07-16","2026-06-26","Ohio State University","OTHER",null,"This prospective, randomized, double-blind, two-arm clinical trial will evaluate whether applying 5% lidocaine ointment to endotracheal tubes before intubation reduces airway irritation compared with standard water-based lubricant in adult patients undergoing general anesthesia. The primary objective is to determine whether lidocaine ointment decreases the incidence of coughing or bucking during emergence and extubation. Secondary objectives include evaluating the incidence and severity of postoperative sore throat and hoarseness, as well as intraoperative opioid requirements. Additional demographic and procedural data will be collected to characterize the study population and adjust for potential confounders. The study hypothesis is that 5% lidocaine ointment will reduce emergence coughing and improve postoperative airway comfort without increasing adverse outcomes.","Emergence coughing or bucking is a common complication of general anesthesia with endotracheal intubation and may result in clinically significant increases in hemodynamic stress, airway irritation, postoperative discomfort, and potential complications. Although multiple pharmacologic strategies have been evaluated to reduce emergence coughing, the effectiveness of topical lidocaine preparations applied to the endotracheal tube remains uncertain.\n\nThis prospective, randomized, double-blind, two-arm clinical trial will evaluate whether applying 5% lidocaine ointment to the external surface of the endotracheal tube before intubation reduces coughing or bucking during emergence from general anesthesia compared with standard water-based endotracheal tube lubricant.\n\nAdult patients undergoing elective surgical procedures requiring general anesthesia with oral endotracheal intubation will be randomized to receive either 5% lidocaine ointment or standard water-based lubricant applied to the external surface of the endotracheal tube immediately prior to intubation. The study will use standardized anesthetic management, double-blinding procedures, and consistent outcome assessment methods.\n\nThe primary outcome is the incidence of coughing or bucking during emergence from anesthesia, assessed from the time anesthetic agents are reduced for extubation until removal of the endotracheal tube. Secondary outcomes include the incidence and severity of postoperative sore throat and hoarseness at defined postoperative time points, as well as total intraoperative opioid administration converted to morphine milligram equivalents.\n\nAdditional demographic and procedural information, including age, sex, body mass index, American Society of Anesthesiologists physical status, airway assessment characteristics, duration of intubation, and surgical procedure type, will be collected to describe the study population and evaluate potential factors associated with outcomes.\n\nThe study aims to determine whether 5% lidocaine ointment provides a clinically useful strategy for reducing emergence-related airway irritation and improving postoperative airway comfort compared with standard endotracheal tube lubrication.",[19],"Emergency Coughing",[],"INTERVENTIONAL","PREVENTION",[24],"EARLY_PHASE1",{"count":26,"type":27},212,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","5% Lidocaine Ointment","A 5% lidocaine ointment will be applied as a thin, uniform layer to the external surface of the endotracheal tube immediately before endotracheal intubation. The ointment will be applied once according to the study protocol before induction of general anesthesia.",[31],{"type":14,"name":35,"description":36,"armGroupLabels":37},"Water-Based Lubricant","Institutional standard water-based endotracheal tube lubricant will be applied to the external surface of the endotracheal tube immediately before endotracheal intubation according to routine clinical practice before induction of general anesthesia.",[35],[39],{"measure":40,"description":41,"timeFrame":42},"Incidence of Coughing or Bucking During Emergence from General Anesthesia","The incidence of coughing or bucking occurring during emergence from anesthesia, defined as any cough or bucking movement from the time anesthetic agents are reduced for extubation until removal of the endotracheal tube. The outcome will be assessed by direct observation and recorded as the presence or absence of coughing\u002Fbucking and the number of bucking episodes using a standardized assessment.","From initiation of emergence from anesthesia until endotracheal tube removal, assessed during the extubation period (approximately 5-30 minutes after anesthetic reduction).",[44,48,51],{"measure":45,"description":46,"timeFrame":47},"Incidence and Severity of Postoperative Sore Throat","Incidence and severity of postoperative sore throat will be assessed using a patient-reported 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Moderate or severe sore throat will be considered clinically significant for analysis.","2 hours and 24 (±3) hours after extubation.",{"measure":49,"description":50,"timeFrame":47},"Incidence and Severity of Postoperative Hoarseness","Incidence and severity of postoperative hoarseness will be assessed using a patient-reported 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Moderate or severe hoarseness will be considered clinically significant for analysis.",{"measure":52,"description":53,"timeFrame":54},"Total Intraoperative Opioid Use","Total opioid administration from induction of anesthesia until extubation, converted to morphine milligram equivalents (MME) for analysis.","From induction of anesthesia until endotracheal tube removal during the intraoperative period.","ALL","18 Years","90 Years",false,{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"Inclusion Criteria:\n\nAdults aged 18 years and older, with an upper age limit of 90 years, scheduled for surgery requiring general anesthesia with an oral endotracheal tube.\n\nPatients undergoing general surgical procedures, including but not limited to abdominal surgeries (e.g., hernia repairs, cholecystectomy, appendectomy, bowel surgery), non-cervical spinal surgeries, craniotomies, orthopedic procedures, urologic procedures, and other procedures meeting the inclusion criteria.\n\nAmerican Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV. Patients able to provide informed consent.\n\nExclusion Criteria:\n\nAge younger than 18 years or older than 90 years. Patients undergoing procedures requiring a specialized airway device instead of a standard oral endotracheal tube (e.g., laryngeal mask airway, double-lumen endobronchial tube).\n\nPatients with known hypersensitivity or allergy to amide local anesthetics. Patients with pre-existing sore throat, upper respiratory infection, or active cough at baseline.\n\nPatients requiring postoperative mechanical ventilation or critically ill patients requiring intensive care.\n\nPatients unable to adequately report outcomes or participate in follow-up assessments.\n\nCurrent smokers. Pregnant women. Prisoners.",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":81},"The Ohio State University Wexner Medical Center","Columbus","Ohio","43201","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Ling-Qun Hu, MD","CONTACT","614-293-3559","lingqun.hu@osumc.edu",{"name":80,"role":76},"Ling-Qun Hu",{"lat":82,"lon":83},39.96118,-82.99879,[85],{"name":75,"role":76,"phone":86,"email":78},"6142933559",[],[],[],{"nct_id":4,"conditions":91,"biomarkers":92},[19],[],{"nct_id":4,"found":94,"summary":95,"prompt_version":105},true,{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is a randomized, double-blind study with two groups, involving 212 participants. You would be randomly assigned to receive either the lidocaine ointment or the standard lubricant.","completed","Lidocaine Ointment for Reducing Coughing After Anesthesia","This study is testing if applying 5% lidocaine ointment to an endotracheal tube (breathing tube) before surgery can reduce coughing or bucking (a forceful cough) when you wake up from general anesthesia. The study compares this to using a standard water-based lubricant. We are looking for adults aged 18 to 90 who are having surgery that requires a breathing tube. The main goal is to see if the lidocaine ointment lowers the number of people who cough or buck as they are waking up and the breathing tube is removed. This study is currently unclear on its recruitment status and aims to enroll 212 participants.","The main outcome of coughing or bucking will be assessed from when you start waking up until the breathing tube is removed, which is typically about 5-30 minutes after the anesthetic is reduced.",105,"Not specified in the trial record.","Not stated in the trial record.",[31,35],"v2"]