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Chronic RhinosinusitisPhase 1/2NCT06457100

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

A Phase 1/2 study testing Esmolol Injection and Lidocaine IV in people with Chronic Rhinosinusitis and Enhanced Recovery After Surgery, run by The Second People's Hospital of Huai'an at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Esmolol Injection and Lidocaine IV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
21 Nov 2023to 22 Jun 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site
  • The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital

    Huaian

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Esmolol Injection, Lidocaine IV
Keywords
Esmolol, Lidocaine, Postoperative recovery, Functional endoscopic sinus surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Esmolol InjectionDrug

    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 IVDrug

    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.

Study groups in NCT06457100
Study groupRoleWhat they receive
EsmololExperimentalIn 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.
Receives: Drug: Esmolol Injection
LidocaineActive comparatorIn 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.
Receives: Drug: Lidocaine IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Preoperative day、Postoperative day 1 、Postoperative day 2

Secondary outcomes (7)
  1. 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.

    Measured: Immediately after surgery

  2. 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.

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

  3. 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.

    Measured: intraoperative

  4. incidence of adverse effects

    the incidence of postoperative nausea, vomiting, and sore throat.

    Measured: Postoperative day 1 、Postoperative day 2

  5. 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.

    Measured: intraoperative

  6. Heart rate(HR)

    perioperative hemodynamic fluctuations

    Measured: admission to operating room、before induction of anesthesia、before intubation、immediately after intubation、start of surgery、end of surgery、at extubation

  7. Mean arterial blood pressure(MAP)

    perioperative hemodynamic fluctuations

    Measured: admission to operating room、before induction of anesthesia、before intubation、immediately after intubation、start of surgery、end of surgery、at extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start21 Nov 2023
  3. Primary completion15 Jun 2024 (estimated)
  4. Study completion22 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06457100
Sponsor's protocol ID
CXie
Status last verified
Jun 2024
First submitted
3 Jun 2024
Last updated
13 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • 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.

    PubMed 30216240
  • 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.

    PubMed 29028742
  • 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.

    PubMed 30826743
  • 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.

    PubMed 33141959
  • 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.

    PubMed 30117019
  • 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.

    PubMed 31684867
  • 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.

    PubMed 33478255

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Esmolol Injection and Lidocaine IV in people with Chronic Rhinosinusitis and Enhanced Recovery After Surgery, run by The Second People's Hospital of Huai'an at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The quality of recovery-15(QoR-15) (time frame: Preoperative day、Postoperative day 1 、Postoperative day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06457100, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.

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