Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery
NCT Number: NCT06457100
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Chronic Rhinosinusitis|Enhanced Recovery After Surgery
Interventions: DRUG: Esmolol Injection|DRUG: Lidocaine IV
Sponsor: The Second People's Hospital of Huai'an
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-21
Completion Date: 2024-06-22
Locations: The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital, Huaian, China

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.

Primary Outcome Measures: The quality of recovery-15（QoR-15）, The QoR-15 scale is divided into five dimensions: physical comfort (5 items), self-care (2 items), psychological support (2 items), emotional state (4 items), and pain (2 items), with each item rated on a scale of 0-10, and the total score ranging from 0-150, with the higher the score the better the quality of recovery, and a score of 118 and above indicating surgery., Preoperative day、Postoperative day 1 、Postoperative day 2
Secondary Outcome Measures: surgical field quality score（SSMQ）, Surgical field quality was scored using the SSFQ scale, which can also be referred to as the Fromme Rating Scale, which consists of a scale of 1 to 5, corresponding to a score of 5 to 1. The higher the rating, the lower the score, and the worse the quality of the operative field., Immediately after surgery|Numeric rating scale（NRS）, NRS is a rating used to assess a patient's level of pain, which is assessed by the patient based on self-perception on a scale from 0 to 10. A score of 0 represents no pain and a score of 10 represents the most pain., 2 hours postoperative、4 hours postoperative、8 hours postoperative、24 hours postoperative、48 hours postoperative|Intraoperative propofol and remifentanil dosage, The dosage of propofol and remifentanil was adjusted according to the depth of anesthesia during the operation, and propofol was maintained at a rate of 5\~8 mg/kg/h, while remifentanil was maintained at 0.5\~1.5 ug/kg/min., intraoperative|incidence of adverse effects, the incidence of postoperative nausea, vomiting, and sore throat., Postoperative day 1 、Postoperative day 2|Intraoperative phenylephrine, atropine, nitroglycerin, ephedrine dosage, Vasoactive drugs may be administered at an appropriate depth of anesthesia. When the mean arterial blood pressure(MAP) was \>75 mmHg, 20 ug of nitroglycerin was given; when the MAP was less than 60 mmHg, 40 ug of phenylephrine was given preferentially, and 3 mg of ephedrine was given after the ineffective treatment; when the heart rate was less than 45 beats/minute, 0.5 mg of atropine was given., intraoperative|Heart rate（HR）, perioperative hemodynamic fluctuations, admission to operating room、before induction of anesthesia、before intubation、immediately after intubation、start of surgery、end of surgery、at extubation|Mean arterial blood pressure(MAP), perioperative hemodynamic fluctuations, admission to operating room、before induction of anesthesia、before intubation、immediately after intubation、start of surgery、end of surgery、at extubation