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 range18 Years – 65 Years

SexALL

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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

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