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

NCT06457100 | Active Not Recruiting Phase 1

• 1 other identifier: CXie
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis; Enhanced Recovery After Surgery

Keywords

Esmolol; Lidocaine; Postoperative recovery; Functional endoscopic sinus surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• surgical field quality score（SSMQ）

  Immediately after surgery

• Numeric rating scale（NRS）

  2 hours postoperative、4 hours postoperative、8 hours postoperative、24 hours postoperative、48 hours postoperative

• Intraoperative propofol and remifentanil dosage

  intraoperative

• incidence of adverse effects

  Postoperative day 1 、Postoperative day 2

• Intraoperative phenylephrine, atropine, nitroglycerin, ephedrine dosage

  intraoperative

Study Arms (2)

Esmolol

EXPERIMENTAL

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.

Drug: Esmolol Injection

Lidocaine

ACTIVE COMPARATOR

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.

Drug: Lidocaine IV

Interventions

Esmolol Injection 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.

Esmolol

Lidocaine IV 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.

Lidocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• American Society of Anesthesiologists (ASA) classification I-II
• Functional endoscopic sinus surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second People's Hospital of Huai'an: lead

Study Sites (1)

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

Huaian, China

Location

Related Publications (8)

• 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.

  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.

  PMID: 30216240 BACKGROUND

• 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.

  PMID: 29028742 BACKGROUND

• 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.

  PMID: 30826743 BACKGROUND

• 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.

  PMID: 33141959 BACKGROUND

• 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.

  PMID: 30117019 BACKGROUND

• 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.

  PMID: 31684867 BACKGROUND

• 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.

  PMID: 33478255 BACKGROUND

MeSH Terms

Interventions

esmolol

Study Officials

• Xie chenglan, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization sequence was generated by a computer and handed over in sealed opaque sequentially numbered envelopes. The envelope was opened by anaesthetist not involved in the study and drugs were dispensed as per the allocation card. The configured drugs were then handed over to experienced anaesthetists who were not aware of the subgroups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 13, 2024
• Study Start: November 21, 2023
• Primary Completion: June 15, 2024
• Study Completion: June 22, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)