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

NCT ID: NCT06457100

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-21
• Study Completion Date: 2024-06-22

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.

Conditions

Chronic Rhinosinusitis; Enhanced Recovery After Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Esmolol

In the esmolol group, esmolol(2ml:0.2g) 0.5 mg/kg was given intravenously, pumped 1 min before induction of anesthesia, and then infused intravenously at 3.0 mg-kg-1 h-1 until the end of surgery.

Group Type: EXPERIMENTAL

Esmolol Injection

Intervention Type: DRUG

Before induction of anesthesia, 0.5 mg/kg of esmolol was pumped intravenously and infused within 1 minute, followed by a pumping rate of 3 mg/kg/h until the end of the procedure.

Lidocaine

In the lidocaine group, lidocaine(5ml:0.1g) 2.0 mg/kg was given intravenously, pumped 10 min before induction of anesthesia and then infused intravenously at 2.0 mg-kg-1 h-1 until the end of surgery.

Group Type: ACTIVE_COMPARATOR

Lidocaine IV

Intervention Type: DRUG

Before induction of anesthesia, 2 mg/kg of lidocaine was pumped intravenously and infused within 10 minute, followed by a pumping rate of 2 mg/kg/h until the end of the procedure.

Interventions

Esmolol Injection

Before induction of anesthesia, 0.5 mg/kg of esmolol was pumped intravenously and infused within 1 minute, followed by a pumping rate of 3 mg/kg/h until the end of the procedure.

Intervention Type: DRUG

Lidocaine IV

Before induction of anesthesia, 2 mg/kg of lidocaine was pumped intravenously and infused within 10 minute, followed by a pumping rate of 2 mg/kg/h until the end of the procedure.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second People's Hospital of Huai'an

OTHER

Sponsor Role: lead

Responsible Party

Chenglan Xie

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xie chenglan, PhD

Role: STUDY_DIRECTOR

The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital

Locations

The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital

Huaian, , China

Countries

China

References

Elaziz R A E A, Shaban S, Elaziz S A. Effects of Lidocaine Infusion on Quality of Recovery and Agitation after Functional Endoscopic Sinus Surgery: Randomized Controlled Study [J]. Open Journal of Anesthesiology, 2020, 10(12): 435-48.

Reference Type: BACKGROUND

Bahr MP, Williams BA. Esmolol, Antinociception, and Its Potential Opioid-Sparing Role in Routine Anesthesia Care. Reg Anesth Pain Med. 2018 Nov;43(8):815-818. doi: 10.1097/AAP.0000000000000873.

Reference Type: BACKGROUND

PMID: 30216240 (View on PubMed)

Gelineau AM, King MR, Ladha KS, Burns SM, Houle T, Anderson TA. Intraoperative Esmolol as an Adjunct for Perioperative Opioid and Postoperative Pain Reduction: A Systematic Review, Meta-analysis, and Meta-regression. Anesth Analg. 2018 Mar;126(3):1035-1049. doi: 10.1213/ANE.0000000000002469.

Reference Type: BACKGROUND

PMID: 29028742 (View on PubMed)

Nair A. Esmolol: an avoidable agent for intraoperative use as an antinociceptive. Reg Anesth Pain Med. 2019 Jun;44(6):683. doi: 10.1136/rapm-2019-100429. Epub 2019 Mar 2. No abstract available.

Reference Type: BACKGROUND

PMID: 30826743 (View on PubMed)

Foo I, Macfarlane AJR, Srivastava D, Bhaskar A, Barker H, Knaggs R, Eipe N, Smith AF. The use of intravenous lidocaine for postoperative pain and recovery: international consensus statement on efficacy and safety. Anaesthesia. 2021 Feb;76(2):238-250. doi: 10.1111/anae.15270. Epub 2020 Nov 3.

Reference Type: BACKGROUND

PMID: 33141959 (View on PubMed)

Beaussier M, Delbos A, Maurice-Szamburski A, Ecoffey C, Mercadal L. Perioperative Use of Intravenous Lidocaine. Drugs. 2018 Aug;78(12):1229-1246. doi: 10.1007/s40265-018-0955-x.

Reference Type: BACKGROUND

PMID: 30117019 (View on PubMed)

Bajracharya JL, Subedi A, Pokharel K, Bhattarai B. The effect of intraoperative lidocaine versus esmolol infusion on postoperative analgesia in laparoscopic cholecystectomy: a randomized clinical trial. BMC Anesthesiol. 2019 Nov 4;19(1):198. doi: 10.1186/s12871-019-0874-8.

Reference Type: BACKGROUND

PMID: 31684867 (View on PubMed)

Moffatt DC, McQuitty RA, Wright AE, Kamucheka TS, Haider AL, Chaaban MR. Evaluating the Role of Anesthesia on Intraoperative Blood Loss and Visibility during Endoscopic Sinus Surgery: A Meta-analysis. Am J Rhinol Allergy. 2021 Sep;35(5):674-684. doi: 10.1177/1945892421989155. Epub 2021 Jan 21.

Reference Type: BACKGROUND

PMID: 33478255 (View on PubMed)

Other Identifiers

CXie

Identifier Type: -

Identifier Source: org_study_id