Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457100
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-03
Brief Title:
Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery
Sponsor:
The Second Peoples Hospital of Huaian
Organization:
The Second Peoples Hospital of Huaian
Study Overview
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 SurgeryA Randomized Non-inferiority Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 vomitingIn addition intravenous lidocaine infusion has been shown to improve the quality of early postoperative recovery and accelerate postoperative recovery in patients with FESSHowever 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 05mgkg for 1 min followed by 30 mgkgh Group L intravenous lidocaine 20 mgkg for 10 min followed by 2 mgkgh 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 11 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 005 mgkg sufentanil 05 µgkg etomidate03 mgkg and rocuroniumbromide 06 mgkg respectively Oxygen denitrification was administered for 3 min followed by endotracheal intubation and connection to a ventilator with pure oxygen of 10 Lmin for respiratory control Setting parameters tidal volume 810 mlkg inspiratory ratio 12 control PETCO2 at 3540 mmHg Group E patients were pumped with saline for 10 min followed by esmolol 05 mgkg for 1 min before the induction of anesthesia and then continuous esmolol 30 mgkgh until the end of the surgery Group L patients were pumped with lidocaine 20 mgkg for 10 min followed by saline for 1 min before the induction of anesthesia and then continuous lidocaine 30 mgkgh until the end of the operation both drugs were diluted to 20 ml with 09 saline The appropriate depth of anesthesia entropy index RESE 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 patients 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
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 05mgkg for 1 min followed by 30 mgkgh Group L intravenous lidocaine 20 mgkg for 10 min followed by 2 mgkgh 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 11 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 005 mgkg sufentanil 05 µgkg etomidate03 mgkg and rocuroniumbromide 06 mgkg respectively Oxygen denitrification was administered for 3 min followed by endotracheal intubation and connection to a ventilator with pure oxygen of 10 Lmin for respiratory control Setting parameters tidal volume 810 mlkg inspiratory ratio 12 control PETCO2 at 3540 mmHg Group E patients were pumped with saline for 10 min followed by esmolol 05 mgkg for 1 min before the induction of anesthesia and then continuous esmolol 30 mgkgh until the end of the surgery Group L patients were pumped with lidocaine 20 mgkg for 10 min followed by saline for 1 min before the induction of anesthesia and then continuous lidocaine 30 mgkgh until the end of the operation both drugs were diluted to 20 ml with 09 saline The appropriate depth of anesthesia entropy index RESE 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None