Effects of Different Drugs for Glottic Atomization on Postoperative Sore Throat After Thyroid Surgery
Evaluation of the Efficacy of Different Drugs Nebulized at the Glottis on Postoperative Sore Throat in Thyroid Surgery With Nerve Monitoring: a Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Postoperative sore throat is a common complication of thyroidectomy under general anesthesia. Multiple factors such as the special surgical position for thyroidectomy and the physical and electrical stimulation from nerve-monitoring endotracheal tubes can aggravate mucosal injury and inflammatory response at the glottis, increase the incidence of postoperative sore throat, and may also be accompanied by adverse reactions such as cough, hoarseness and dysphagia. These issues significantly reduce patients' postoperative comfort and hinder the process of enhanced postoperative recovery. As a non-invasive local drug administration method, glottic nebulization can act directly on the damaged mucous membrane of the pharynx and larynx, increase the local drug concentration, and exhibit significant advantages in alleviating pharyngolaryngeal inflammation and pain. Budesonide combined with lidocaine has potential preventive and therapeutic effects on postoperative sore throat, yet its efficacy and clinical application value in glottic nebulization for thyroidectomy with nerve monitoring have not been systematically verified.
This study aims to systematically evaluate the preventive and therapeutic efficacy of glottic nebulization with budesonide combined with lidocaine versus normal saline after tracheal intubation on postoperative sore throat in patients undergoing thyroidectomy with nerve monitoring, and to clarify the impact of nebulization with different drugs on the incidence of postoperative sore throat. Meanwhile, it analyzes the improvement effect of nebulization with different drugs on the four-point scale scores and NRS scores of sore throat at immediate extubation, 12 hours and 24 hours after surgery, and explores its regulatory effect on the severity and duration of sore throat. In addition, this study will observe the impacts of different drug nebulization regimens on the occurrence of related adverse reactions such as cough, hoarseness and dysphagia in patients after surgery, as well as indicators including blood-stained endotracheal tube at extubation, operation duration and postoperative intubation time. It comprehensively compares the efficacy and safety of the two nebulization regimens, so as to provide scientific and reliable evidence-based medical evidence for the clinical formulation of individualized preventive and therapeutic regimens for postoperative sore throat in thyroidectomy with nerve monitoring, further optimize the perioperative management strategy for such surgeries, and improve patients' postoperative comfort and the level of enhanced postoperative recovery.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Shandong
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Jinan, Shandong, China, 250000
- Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants have a full understanding of the purpose and significance of this trial, voluntarily participate in the trial, and sign the informed consent form;
- Undergoing thyroidectomy with nerve monitoring under general anesthesia (with successful tracheal intubation at the first attempt);
- Aged 18 to 60 years, regardless of gender;
- Body mass index (BMI) ranging from 18 kg/m² to 30 kg/m²;
- Surgical duration of 1 to 4 hours;
- American Society of Anesthesiologists (ASA) physical status classification Grade I-II;
- No contraindications to the study drugs.
Exclusion Criteria:
- Current smokers or patients with pre-operative sore throat;
- A recent history of upper or lower respiratory tract infection;
- Patients who refuse to participate in this study;
- Complicated with significant hepatic, renal or other organ dysfunction;
- Pregnancy or lactation period;
- Patients with a Mallampati classification of Grade Ⅲ or above (Mallampati classification >2);
- Nasogastric tube required during surgery;
- Reoperative thyroidectomy;
- Pre-operative administration of non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics;
- Patients with chronic pharyngitis or gastroesophageal reflux disease (GERD);
- More than two attempts of tracheal intubation by an experienced anesthesiologist;
- Patients with a known allergy to the study drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: intervention group
Upon arrival in the operating room, routine monitoring was performed on the participants, including electrocardiogram (ECG), pulse oxygen saturation (SpO₂), non-invasive blood pressure (NIBP), and skin temperature, together with bispectral index (BIS) monitoring for anesthetic depth. Anesthesia induction was conducted with midazolam 0.03 mg/kg, sufentanil 0.4 μg/kg, etomidate 0.4 mg/kg, and atracurium 0.6 mg/kg. After pre-oxygenation via face mask, tracheal intubation was performed, and the patient was connected to the anesthesia machine. Then, 1 mL budesonide plus 4 mL lidocaine was administered by nebulization at the glottis. Anesthesia maintenance was achieved with target-controlled infusion of propofol at 0.5-2 μg/mL and remifentanil at 0.2-0.3 μg/kg/min, maintaining the BIS value between 40 and 60. |
Following anesthesia induction, tracheal intubation was performed. The patients received continuous nebulization of 1 mg (2 mL) budesonide combined with 4 mL of 2% lidocaine at the glottis. The control group received 5 mL of normal saline via nebulization at the glottis. |
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Placebo Comparator: control group
Upon arrival in the operating room, routine monitoring was performed on the participants, including electrocardiogram (ECG), pulse oxygen saturation (SpO₂), non-invasive blood pressure (NIBP), skin temperature, and bispectral index (BIS) monitoring for anesthetic depth. Anesthesia induction was conducted with midazolam 0.03 mg/kg, sufentanil 0.4 μg/kg, etomidate 0.4 mg/kg, and atracurium 0.6 mg/kg. After pre-oxygenation via face mask, tracheal intubation was performed, and the participants were connected to the anesthesia machine. 5 mL of normal saline was administered by nebulization at the glottis. Anesthesia maintenance was achieved with target-controlled infusion of propofol at 0.5-2 μg/mL and remifentanil at 0.2-0.3 μg/kg/min, maintaining the BIS value between 40 and 60. |
After anesthesia induction, tracheal intubation was performed, and the patient received continuous nebulization of 5 mL normal saline at the glottis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The incidence of postoperative sore throat
Time Frame: within the first 24 postoperative hours
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Postoperative sore throat (POST) is one of the common complications following general anesthesia with endotracheal intubation, with a reported incidence of 30% to 70%.
Severe POST, accompanied by cough, hoarseness, dysphagia, and other symptoms, significantly reduces patients' postoperative comfort and satisfaction, and is detrimental to rapid postoperative recovery.
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within the first 24 postoperative hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Four-point scale score for postoperative sore throat
Time Frame: immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively
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The 4-point pain scale is a simple tool for assessing pain intensity using a 0-3 scale: 0 = no pain,
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immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively
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Patients' postoperative NRS scores
Time Frame: immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively
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The NRS is an 11-point numerical pain assessment scale that uses 11 numbers ranging from 0 to 10 to represent the intensity of pain from no pain to the most severe pain.
Patients select the corresponding number based on their own pain perception to quantify pain intensity, making it one of the most commonly used tools for perioperative and postoperative pain evaluation.
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immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively
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The Anesthesia duration time
Time Frame: From anesthesia induction to departure from the operating room
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The time from the completion of anesthesia induction with tracheal intubation to the end of surgery and departure from the operating room.
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From anesthesia induction to departure from the operating room
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Postoperative tracheal catheterization time
Time Frame: end of surgery and admission to the post-anesthesia care unit (PACU) until successful extubation of the endotracheal tube,
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Refers to the time interval from the end of surgery and admission to the post-anesthesia care unit (PACU) until successful extubation of the endotracheal tube, usually measured in minutes.
It is an important indicator for evaluating airway management, postoperative recovery, and extubation safety.
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end of surgery and admission to the post-anesthesia care unit (PACU) until successful extubation of the endotracheal tube,
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The number of cases with postoperative cough, hoarseness and difficulty in swallowing.
Time Frame: From immediately after extubation to 24 hours postoperatively
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From immediately after extubation to 24 hours postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liang Guo, Qianfoshan Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QianfoshanH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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