Clinical trial NCT06457100: Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery
Official title: Comparison of the Effects of Perioperative Intravenous Infusions of Esmolol and Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery:A Randomized, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Rhinosinusitis
Enhanced Recovery After Surgery
Keywords: Esmolol
Lidocaine
Postoperative recovery
Functional endoscopic sinus surgery
Lead sponsor: The Second People's Hospital of Huai'an
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the esmolol group, 0.5 mg/kg esmolol was injected before the induction of anesthesia, and the injection was completed within 1 min, followed by continuous intravenous pumping of esmolol 50 ug/(kg-min) until the end of surgery.
Primary purpose: TREATMENT

Brief 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.

Detailed description: In recent years, the concept of enhanced recovery after surgery (ERAS) has been widely used in the perioperative period of different diseases, but it has been rarely reported in patients undergoing functional endoscopic sinus surgery (FESS).

Therefore, the aim of this article was to compare the effects of esmolol and lidocaine on the quality of postoperative recovery in patients undergoing FESS. patients were randomly divided into: Group E: intravenous esmolol (0.5mg/kg for 1 min, followed by 3.0 mg/kg/h); Group L: intravenous lidocaine( 2.0 mg/kg for 10 min, followed by 2 mg/kg/h). The quality of recovery-15 (QoR-15) score was observed and compared between the two groups. Other parameters compared were: intraoperative field conditions, hemodynamic data, propofol, opioid and vasoactive drug dosage, Numeric rating pain scale (NRS), awakening and incidence of adverse effects.

The inclusion criteria were: age between 18 and 65 years, American Society of Anesthesiologists (ASA) classification I-II, FESS under general anesthesia. unsigned informed consent; 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; those who were allergic to the drugs used in the experiment (such as esmolol or lidocaine) or experienced adverse drug reactions; pregnant and lactating women; those who had been taking long-term sedative or analgesic drugs, or who were chronically intoxicated; those with a history of psychiatric illnesses or those who had verbal communication disorders and were unable to comprehend the experimental content; and those who had a duration of surgery of more than 3 h; Patients who had a difficult airway during induction of anesthesia and required a change in routine intubation were excluded from this study.

Using a computer-generated randomization sequence and the sealed-envelope method, patients were randomly assigned to the esmolol and lidocaine groups in a 1:1 ratio. Patients, anesthesiologists, and investigators observing the results were unaware of the allocation of patient groups.

The patients were routinely fasted for 6 h and abstained from drinking for 2 h preoperatively. All patients were not anesthetized with premedication. After admission, patients were routinely administered oxygen by mask, peripheral venous access was opened and cardiac monitoring, including noninvasive blood pressure, pulse oximetry, electrocardiogram, body temperature and entropy index, was routinely performed. Both groups were routinely rapidly induced with midazolam 0.05 mg/kg, sufentanil 0.5 µg/kg, etomidate0.3 mg/kg, and rocuroniumbromide 0.6 mg/kg, respectively. Oxygen denitrification was administered for 3 min followed by endotracheal intubation and connection to a ventilator with pure oxygen of 1.0 L/min for respiratory control. Setting parameters: tidal volume 8～10 ml/kg, inspiratory ratio 1:2, control PETCO2 at 35～40 mmHg. Group E patients were pumped with saline for 10 min, followed by esmolol (0.5 mg/kg) for 1 min before the induction of anesthesia, and then continuous esmolol 3.0 mg/kg/h until the end of the surgery; Group L patients were pumped with lidocaine (2.0 mg/kg) for 10 min, followed by saline for 1 min before the induction of anesthesia , and then continuous lidocaine 3.0 mg/kg/h until the end of the operation. (both drugs were diluted to 20 ml with 0.9% saline). The appropriate depth of anesthesia (entropy index RE/SE 40-60) was maintained by adjusting the infusion rate of propofol and remifentanil. MAP was controlled at 60-75 mmHg, and vasoactive drugs (ephedrine, phenylephrine, and nitroglycerin) could be administered to regulate the blood pressure at the appropriate depth of anesthesia. After the operation, the patient was immediately transferred to the PACU. when the patient regained consciousness and could breathe on his own, the tracheal tube was removed. In the PACU, 30 mg of ketorolac tromethamine was administered intravenously to relieve analgesia if the patient's NRS score was ≥5 or if the patient required analgesia.

All scales were assessed by an independent anesthesiologist who was also unaware of the group assignment. The primary endpoint was QoR and was assessed at POD1 using the QoR-15 scale, a global measure of postoperative recovery. The QoR-15 scale consists of five dimensions, physical comfort, physical independence, emotional state, psychosocial support, and pain, with 15 items and a total score of 150 points. The higher the score, the better the quality of recovery. Secondary endpoints included: QoR-15 scores at preoperative (Preop) and POD2; NRS scores at 2 h, 4 h, 8 h, 24 h and 48 h postoperatively; MAP and HR at the time of patient admission, before induction, before intubation, immediately after intubation, 5 min after intubation, at the beginning of surgery, 5 min after the beginning of surgery, at the end of surgery, at the time of extubation, immediately after extubation, 5 min after extubation, and 30 min after extubation; the SF conditions (SSFQ is evaluated by the surgeon); intraoperative dosage of propofol, remifentanil, and vasoactive medications; the time to awakening and time to extubation (time from discontinuation to awakening and extubation); and the incidence of postoperative nausea, vomiting, and sore throat.

Eligibility criteria: 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

Primary outcomes:
measure: The quality of recovery-15（QoR-15）
timeFrame: Preoperative day、Postoperative day 1 、Postoperative day 2
Secondary outcomes:
measure: surgical field quality score（SSMQ）
timeFrame: Immediately after surgery
measure: Numeric rating scale（NRS）
timeFrame: 2 hours postoperative、4 hours postoperative、8 hours postoperative、24 hours postoperative、48 hours postoperative
measure: Intraoperative propofol and remifentanil dosage
timeFrame: intraoperative
measure: incidence of adverse effects
timeFrame: Postoperative day 1 、Postoperative day 2
measure: Intraoperative phenylephrine, atropine, nitroglycerin, ephedrine dosage
timeFrame: intraoperative
measure: Heart rate（HR）
timeFrame: admission to operating room、before induction of anesthesia、before intubation、immediately after intubation、start of surgery、end of surgery、at extubation
measure: Mean arterial blood pressure(MAP)
timeFrame: admission to operating room、before induction of anesthesia、before intubation、immediately after intubation、start of surgery、end of surgery、at extubation
Other outcomes:
Locations:
city: Huaian
country: China
facility: The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital
Study officials:
affiliation: The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital
name: Xie chenglan, PhD
role: STUDY_DIRECTOR
References:
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