Active — Not RecruitingPhase 1/2

Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery

China60 participantsStarted 2023-11-21

Plain-language summary

Functional endoscopic sinus surgery (FESS) is one of the effective modalities for the treatment of chronic sinusitis, with the advantages of deep approach, light trauma, and less pain. However, because the operation area involves the nose, eyes and cranial region, the surrounding tissue structure is complex and rich in blood vessels and nerves, and the use of epinephrine, intraoperative tissue damage, nerve stimulation, and postoperative inflammation, edema, hemorrhage, and nasal cavity stuffing can cause patients' stress reaction and postoperative pain, resulting in patients' anxiety, depression, and sleep disorders, which can reduce the quality of early postoperative recovery, and affect the patients' rapid postoperative recovery. Esmolol is a selective β1-adrenergic receptor blocker with fast onset of action and short duration of action, which has the ability to reduce heart rate, blood pressure and myocardial protection. In recent years, several studies have found that esmolol not only reduces perianesthesia stress, but also reduces postoperative pain, decreases intraoperative and postoperative opioid requirements, and reduces the incidence of postoperative nausea and vomiting.In addition, intravenous lidocaine infusion has been shown to improve the quality of early postoperative recovery and accelerate postoperative recovery in patients with FESS.However, the dose of the drug administered is unclear and the range of safe infusion doses is narrow, requiring plasma concentration monitoring to prevent toxic reactions to local anesthetics. Its clinical application may lead to prolonged sinus bradycardia, increasing the cardiovascular risk of patients. Therefore, this study was designed to characterize the FESS procedure with the aim of determining that esmolol is not inferior to lidocaine in FESS in terms of the quality of postoperative recovery and is more advantageous in terms of controlling hemorrhage, guaranteeing a clear operative field, and the safety of the medication.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 65 years * American Society of Anesthesiologists (ASA) classification I-II * Functional endoscopic sinus surgery under general anesthesia Exclusion Criteria: * Major organ disease (such as cardiac, cerebral, pulmonary, hepatic, and renal disease) * Bradycardia and atrioventricular block * Bronchial asthma or history of bronchial asthma * Patients with uncontrolled hypertension or hyperthyroidism * Patients with diabetes mellitus or hearing impairment * Patients who were allergic to the drugs used in the experiment (such as esmolol or lidocaine) or experienced adverse drug reactions * Pregnant and lactating women * Patients who had been taking long-term sedative or analgesic drugs, or who were chronically intoxicated * Patients with a history of psychiatric illnesses or those who had verbal communication disorders and were unable to comprehend the experimental content * Patients who had a duration of surgery of more than 3 hours * Patients who had a difficult airway during induction of anesthesia and required a change in routine intubation were excluded from this study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The quality of recovery-15（QoR-15）

Timeframe: Preoperative day、Postoperative day 1 、Postoperative day 2

Trial details

NCT IDNCT06457100

SponsorThe Second People's Hospital of Huai'an

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-15

View on ClinicalTrials.gov More Chronic Rhinosinusitis trials