Effects of Esketamine Versus Magnesium Sulfate on Emotional State and Postoperative Pain in Patients Undergoing Nasal Endoscopic Surgery

NCT06920576 | Active Not Recruiting Phase 1

• 1 other identifier: CLXie
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Functional endoscopic sinus surgery (FESS) is one of the effective modalities for the treatment of Functional endoscopic sinus surgery (FESS) is one of the effective ways to treat chronic sinusitis, which has the advantages of deep approach, light trauma and less pain. However, the operation area involves the nose, eyes and skull. However, because the operation area involves the nose, eyes and skull, the surrounding tissue structure is complex and rich in blood vessels and nerves, and the use of epinephrine, tissue damage, nerve irritation and other problems during the operation are all related to the treatment of chronic rhinosinusitis.However, because the operation area involves the nose, eyes and skull, the surrounding tissue structure is complex and rich in blood vessels and nerves, and the use of epinephrine, intraoperative tissue damage, nerve stimulation, postoperative inflammation, oedema, bleeding, nasal tamponade can cause stress reactions and The use of adrenaline, intraoperative tissue damage, nerve stimulation, postoperative inflammation, oedema, bleeding, and nasal tamponade can all cause stress reactions and postoperative pain in patients, resulting in anxiety, depression, and sleep disorders, thus reducing the quality of early postoperative recovery and affecting This reduces the quality of early postoperative recovery and affects the rapid recovery of patients. As an NMDA receptor antagonist, esketamine has a strong analgesic effect, fast onset of action and rapid metabolism. As an NMDA receptor antagonist, esketamine has a strong analgesic effect, fast onset of action and fast metabolism, which can effectively alleviate postoperative pain, reduce the need for analgesic drugs, prolong the duration of analgesia, reduce the use of opioids and prevent pain hypersensitivity and preventing nociceptive allergy. In addition, esketamine has been proved to be effective in improving depression and anxiety, as well as sleep disorders. In addition, esketamine has been shown to be effective in improving depression and anxiety and in improving sleep disorders. Based on the action of NMDA receptor antagonists, magnesium sulphate reduces opioid consumption and decreases postoperative pain scores, without increasing opioid use. Postoperative pain scores, without increasing the risk of opioid side effects, significantly enhancing perioperative analgesia and reducing the need for analgesia 24 hours after surgery. Magnesium sulphate can reduce opioid consumption and postoperative pain scores without increasing the risk of opioid side effects, significantly enhancing perioperative analgesia and reducing the need for analgesia 24 hours after surgery. At present, few studies and experiences have been reported on the use of esketamine and magnesium sulphate in ERAS in otorhinolaryngology, head and neck surgery. At present, there are few studies and experiences on the use of esketamine and magnesium sulfate in ERAS in otolaryngology, head and neck surgery. The aim of this study was to investigate the effects of intravenous infusion of esketamine or magnesium sulfate on postoperative pain and emotional state in patients undergoing nasal endoscopy. The aim of this study was to investigate the effects of intravenous infusion of esketamine or magnesium sulfate on postoperative pain, emotional state and quality of recovery in patients undergoing nasal endoscopy.

Conditions

Chronic Rhinosinusitis; Enhanced Recovery After Surgery

Keywords

Esketamine; magnesium sulfate; emotional state; Functional endoscopic sinus surgery

Outcome Measures

Primary Outcomes (4)

• Hospital Anxiety and Depression Scale

  The HAD scale consists of 14 items divided into two subscales, anxiety and depression, each subscale contains 7 items, each item is rated on a scale of 0-3, and the total score for anxiety and depression is 0-21.A score of \>7 on the HAD scale can be used as a differentiating value for anxiety and/or depression, with scores of 8-10 as mild anxiety and/or depression, 11-14 as moderate anxiety and/or depression, and 15- 21 are classified as severe anxiety and/or depression.

  Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 3 (POD3)

• Self-Assessment Scale for Anxiety (SAS)

  The SAS was developed by Zung WW in 1971 to rate patients' subjective feelings of anxiety and changes in treatment.The SAS has 20 items, which are rated on a 4-point scale of 1-4 according to the frequency of symptoms, with 5 reverse scores. The total score was summed to obtain the crude score, and then the crude score was multiplied by 1.25 and the whole number portion was taken to obtain the standard score. The SAS cut-off value was 50 points according to the Chinese normative criteria, with 50-59 points for mild anxiety, 60-69 points for moderate anxiety, and higher than 69 points for severe anxiety.

  Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 3 (POD3)

• Depression Self-Rating Scale（SDS）

  The SDS was developed by Zung WW in 1965 to visualise patients' subjective feelings of depression and changes in treatment. The scale is similar to the SAS, with 20 items reflecting an individual's subjective feelings of depression, and is rated on a 4-point scale of 1-4, including 10 reverse scores. The SDS scores were summed to obtain a total crude score, and the standard score was obtained by multiplying the crude score by 1.25 and taking the integer part. The SDS cut-off value according to the Chinese normative scale was 53, with mild depression ranging from 53-62, moderate depression from 63-72, and severe depression above 73.

  Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 3 (POD3)

• Pain visual analogue score (VAS)

  The visual analogue scale (VAS) is used for pain assessment. It is widely used in Chinese clinics, and the basic method is to use a 10-cm-long travelling scale with 10 scales on one side and '0' and '10' scores at both ends, with 0 indicating no pain and 10 representing the most severe pain that is difficult to tolerate. 0 is no pain, 1-3 is mild pain; 4-6 is moderate pain, which affects sleep and is still tolerable; 7-10 is severe pain, which is intolerable and affects sleep and appetite.

  2, 24, 48 and 72 hours postoperatively

Secondary Outcomes (5)

• Intraoperative Propofol and Remifentanil Dosage

  intraoperative

• incidence of adverse effects

  Postoperative day 1 、Postoperative day 2

• Intraoperative phenylephrine, atropine, nitroglycerin, ephedrine dosage

  intraoperative

• Heart rate（HR）

  Perioperative:entering the operating room, before induction of anesthesia, before intubation, immediately after intubation, start of surgery, end of surgery, at extubation

• Mean arterial blood pressure(MAP)

  Perioperative: entering the operating room, before induction of anesthesia, before intubation, immediately after intubation, start of surgery, end of surgery, at extubation

Study Arms (3)

Esketamine

EXPERIMENTAL

Patients were given intravenous esketamine 0.25 mg/kg 10 min before induction of anaesthesia, followed by continuous pumping at 0.25 mg/(kg-h) until the end of the operation.

Drug: Esketamine

Magnesium Sulfate

EXPERIMENTAL

Patients in the magnesium sulphate group (Group L) were injected with 30 mg/kg of magnesium sulphate intravenously 10 min before the induction of anaesthesia, followed by continuous pumping at 30 mg/(kg-h) until the end of the operation.

Drug: Magnesium sulfate

Saline

PLACEBO COMPARATOR

Control (Group C) patients were pumped with equal volume of saline during the same time period.

Drug: Saline

Interventions

Esketamine DRUG

Intravenous esketamine 0.25 mg/kg was administered 10 min before induction of anaesthesia, followed by continuous pumping at 0.25 mg/(kg-h) until the end of the operation.

Esketamine

Magnesium sulfate DRUG

Intravenous magnesium sulphate 30 mg/kg was administered within 10 min before induction of anaesthesia, followed by continuous pumping at 30 mg/(kg-h) until the end of the operation

Magnesium Sulfate

Saline DRUG

Pumping equal volumes of saline over the same time period

Saline

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
• Patients scheduled for FESS under general anaesthesia and with a procedure duration of not less than 30 minutes.

You may not qualify if:

• Patients with hypersensitivity to esketamine, magnesium sulphate and other anaesthetic drugs;
• Combined vital organ insufficiency;
• Pregnant and lactating women;
• Those with a history of substance abuse;
• Patients who are unable to understand the study or who are mentally ill;
• Uncontrolled diabetes mellitus, hypertension, hyperthyroidism;
• Failure to understand or cooperate with HADS, SAS, SDS questionnaires, or the Pain Assessment Scale (VAS);
• Those who do not sign the informed consent form.

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 (6)

• Xu H, Hao C, Wang X, Du J, Zhang T, Zhang X. Effect of Intraoperative infusion Magnesium Sulfate Infusion on Postoperative Quality of Recovery in Patients Undergoing Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial. Drug Des Devel Ther. 2024 Mar 25;18:919-929. doi: 10.2147/DDDT.S444896. eCollection 2024.

  PMID: 38560523 BACKGROUND

• Hung KC, Chang LC, Ho CN, Hsu CW, Wu JY, Lin YT, Chen IW. Influence of Intravenous Magnesium Sulfate Infusion on the Subjective Postoperative Quality of Recovery: A Meta-Analysis of Randomized Controlled Trials. Nutrients. 2024 Jul 22;16(14):2375. doi: 10.3390/nu16142375.

  PMID: 39064818 BACKGROUND

• Kilic K, Sakat MS, Sahin A, Ahiskalioglu EO, Altunok H. Efficacy of intravenous magnesium sulfate infusion on postoperative pain and quality of recovery for septorhinoplasty: a randomized controlled study. Acta Otolaryngol. 2023 Nov-Dec;143(11-12):979-983. doi: 10.1080/00016489.2023.2289584. Epub 2024 Jan 26.

  PMID: 38108626 BACKGROUND

• Zhou Y, Lan X, Wang C, Zhang F, Liu H, Fu L, Li W, Ye Y, Hu Z, Chao Z, Ning Y. Effect of Repeated Intravenous Esketamine on Adolescents With Major Depressive Disorder and Suicidal Ideation: A Randomized Active-Placebo-Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2024 May;63(5):507-518. doi: 10.1016/j.jaac.2023.05.031. Epub 2023 Jul 4.

  PMID: 37414272 BACKGROUND

• Yan H, Chen W, Chen Y, Gao H, Fan Y, Feng M, Wang X, Tang H, Yin J, Qian Y, Ding M, Cang J, Miao C, Wang H. Opioid-Free Versus Opioid-Based Anesthesia on Postoperative Pain After Thoracoscopic Surgery: The Use of Intravenous and Epidural Esketamine. Anesth Analg. 2023 Aug 1;137(2):399-408. doi: 10.1213/ANE.0000000000006547. Epub 2023 Jul 14.

  PMID: 37267129 BACKGROUND

• Xu Y, He L, Liu S, Zhang C, Ai Y. Intraoperative intravenous low-dose esketamine improves quality of early recovery after laparoscopic radical resection of colorectal cancer: A prospective, randomized controlled trial. PLoS One. 2023 Jun 2;18(6):e0286590. doi: 10.1371/journal.pone.0286590. eCollection 2023.

  PMID: 37267303 BACKGROUND

MeSH Terms

Interventions

Esketamine; Magnesium Sulfate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

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

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 10, 2025
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 20, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)