Chronic RhinosinusitisPhase 1/2NCT06920576
Effects of Esketamine Versus Magnesium Sulfate on Emotional State and Postoperative Pain in Patients Undergoing Nasal Endoscopic Surgery
A Phase 1/2 study testing Esketamine, Magnesium sulfate and Saline 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.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Rhinosinusitis, Enhanced Recovery After Surgery
- What is being tested?
- Esketamine, Magnesium sulfate and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 20 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Patients scheduled for FESS under general anaesthesia and with a procedure duration of not less than 30 minutes.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital
Huaian
About this study
Official title: Effect of Perioperative Intravenous Infusion of Esketamine or Magnesium Sulphate on Emotional State and Postoperative Pain in Patients Undergoing Nasal Endoscopic Surgery: a Randomised, Controlled Trial
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.
Read the detailed description
The aim of this study was to investigate the effects of intravenous infusion of esketamine or magnesium sulphate on postoperative pain and quality of recovery in patients undergoing nasal endoscopic surgery.Patients were randomised into group S: intravenous infusion of esketamine (0.25 mg/kg over 10 minutes before induction, then 0.25 mg/kg/h); group L intravenous infusion of magnesium sulphate (30 mg/kg over 10 minutes before induction, then 30 mg/kg/h). The control group was pumped with an equal volume of saline over the same time period. Patients were randomly allocated to the esketamine group, magnesium sulphate group and control group in a 1:1 ratio using a computer generated random sequence and the sealed envelope method. Patients, anaesthetists and researchers observing the results were unaware of the allocation of patients to groups.The patients were routinely fasted for 6 h and abstained from drinking for 2 h preoperatively.The patient was admitted to the room with an open peripheral vein and a continuous infusion of sodium lactate Ringer's solution; cardiac monitoring, pulse rate were routinely performed,oxygen saturation (SpO2) and ECG.A temperature-controlled blanket was used intraoperatively to maintain normothermia. In all three groups, intravenous midazolam 0.05 mg/kg, propofol 1.5 mg/kg, rocuronium bromide 0.6 mg/kg, and sufentanil 0.5 μg/kg were injected.The patients in all three groups were induced with intravenous midazolam 0.05 mg/kg, propofol 1.5 mg/kg, rocuronium bromide 0.6 mg/kg, and sufentanil 0.5 μg/kg for routine fast-channel induction. During anaesthesia maintenance, remifentanil 0.1-0.5 ug/kg/min, sevoflurane (1%-3%) and propofol 4-12 mg/kg were continuously infused in all three groups.Sevoflurane (1%-3%), and Propofol 4-12 mg/kg/h were continuously infused in all three groups. All three groups of patients were connected to a ventilator with 2.0 L/min of pure oxygen for respiratory control, and the parameters were set as follows: tidal volume of 6-8 ml/kg, inspiratory/expiratory ratio of 1:2, and PETCO2 control of 35-40 mmHg. The appropriate depth of anaesthesia was maintained.Maintain appropriate anaesthesia depth (entropy index RE/SE 40～60).At the appropriate depth of anaesthesia, vasoactive drugs (ephedrine, phenylephrine, nitroglycerin) can be administered to regulate blood pressure. Immediately after the procedure, the patient is transferred to the PACU and the endotracheal tube is removed when the patient regains consciousness and can breathe spontaneously. In the PACU, pain severity was measured at fixed intervals on a 10-point numerical rating scale (VAS, 0-10), and postoperative VAS scores >3 were given intravenously with ketorolac aminotriol injection 30 mg for remedial analgesia.
- Being tested
- Esketamine, Magnesium sulfate, Saline
- Keywords
- Esketamine, magnesium sulfate, emotional state, Functional endoscopic sinus surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
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.
Magnesium sulfateDrug
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
SalineDrug
Pumping equal volumes of saline over the same time period
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Magnesium sulfate |
| Saline | Placebo comparator | Control (Group C) patients were pumped with equal volume of saline during the same time period. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2, 24, 48 and 72 hours postoperatively
Secondary outcomes (5)
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 4~12 mg/kg/h, while remifentanil was maintained at 0.5~1.5 ug/kg/min.
Measured: intraoperative
incidence of adverse effects
The incidence of perioperative hypotension, hypertension, bradycardia, and tachycardia; PONV; and adverse effects (headache, dizziness, nightmares, sleep disturbances, and mood disorders) was recorded;
Measured: Postoperative day 1 、Postoperative day 2
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
Heart rate（HR）
perioperative hemodynamic fluctuations
Measured: 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 hemodynamic fluctuations
Measured: Perioperative: entering the 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.
- First posted10 Apr 2025
- Study start1 Mar 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second People's Hospital of Huai'an
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenglan Xie, The Second People's Hospital of Huai'an
- Investigators
- Xie chenglan, PhD, Study director, The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920576
- Sponsor's protocol ID
- CLXie
- Status last verified
- Apr 2025
- First submitted
- 14 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38560523Hung 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.
PubMed 39064818Kilic 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.
PubMed 38108626Zhou 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.
PubMed 37414272Yan 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.
PubMed 37267129Xu 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.
PubMed 37267303
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Intravenous Infusion of Esketamine or Magnesium Sulphate on Emotional State and Postoperative Pain in Patients Undergoing Nasal Endoscopic Surgery: a Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT06920576
- Acronym / sponsor ID
- CLXie
- Keywords
- Esketamine, magnesium sulfate, emotional state, Functional endoscopic sinus surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (actual)
- Lead sponsor
- The Second People's Hospital of Huai'anUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study was to investigate the effects of intravenous infusion of esketamine or magnesium sulphate on postoperative pain and quality of recovery in patients undergoing nasal endoscopic surgery.Patients were randomised into group S: intravenous infusion of esketamine (0.25 mg/kg over 10 minutes before induction, then 0.25 mg/kg/h); group L intravenous infusion of magnesium sulphate (30 mg/kg over 10 minutes before induction, then 30 mg/kg/h). The control group was pumped with an equal volume of saline over the same time period. Patients were randomly allocated to the esketamine group, magnesium sulphate group and control group in a 1:1 ratio using a computer generated random sequence and the sealed envelope method. Patients, anaesthetists and researchers observing the results were unaware of the allocation of patients to groups.The patients were routinely fasted for 6 h and abstained from drinking for 2 h preoperatively.The patient was admitted to the room with an open peripheral vein and a continuous infusion of sodium lactate Ringer's solution; cardiac monitoring, pulse rate were routinely performed,oxygen saturation (SpO2) and ECG.A temperature-controlled blanket was used intraoperatively to maintain normothermia. In all three groups, intravenous midazolam 0.05 mg/kg, propofol 1.5 mg/kg, rocuronium bromide 0.6 mg/kg, and sufentanil 0.5 μg/kg were injected.The patients in all three groups were induced with intravenous midazolam 0.05 mg/kg, propofol 1.5 mg/kg, rocuronium bromide 0.6 mg/kg, and sufentanil 0.5 μg/kg for routine fast-channel induction. During anaesthesia maintenance, remifentanil 0.1-0.5 ug/kg/min, sevoflurane (1%-3%) and propofol 4-12 mg/kg were continuously infused in all three groups.Sevoflurane (1%-3%), and Propofol 4-12 mg/kg/h were continuously infused in all three groups. All three groups of patients were connected to a ventilator with 2.0 L/min of pure oxygen for respiratory control, and the parameters were set as follows: tidal volume of 6-8 ml/kg, inspiratory/expiratory ratio of 1:2, and PETCO2 control of 35-40 mmHg. The appropriate depth of anaesthesia was maintained.Maintain appropriate anaesthesia depth (entropy index RE/SE 40～60).At the appropriate depth of anaesthesia, vasoactive drugs (ephedrine, phenylephrine, nitroglycerin) can be administered to regulate blood pressure. Immediately after the procedure, the patient is transferred to the PACU and the endotracheal tube is removed when the patient regains consciousness and can breathe spontaneously. In the PACU, pain severity was measured at fixed intervals on a 10-point numerical rating scale (VAS, 0-10), and postoperative VAS scores >3 were given intravenously with ketorolac aminotriol injection 30 mg for remedial analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Esketamine | Experimental | Drug: EsketaminePatients 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. |
| Magnesium Sulfate | Experimental | Drug: Magnesium sulfatePatients 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. |
| Saline | Placebo comparator | Drug: SalineControl (Group C) patients were pumped with equal volume of saline during the same time period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineIntravenous 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. | Drug | Esketamine |
| Magnesium sulfateIntravenous 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 | Drug | Magnesium Sulfate |
| SalinePumping equal volumes of saline over the same time period | Drug | Saline |
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 3 (POD3)
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.
Self-Assessment Scale for Anxiety (SAS)
Time frame: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 3 (POD3)
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.
Depression Self-Rating Scale（SDS）
Time frame: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 3 (POD3)
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.
Pain visual analogue score (VAS)
Time frame: 2, 24, 48 and 72 hours postoperatively
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.
5 secondary outcomes
Intraoperative Propofol and Remifentanil Dosage
Time frame: intraoperative
incidence of adverse effects
Time frame: Postoperative day 1 、Postoperative day 2
Intraoperative phenylephrine, atropine, nitroglycerin, ephedrine dosage
Time frame: intraoperative
Heart rate（HR）
Time frame: 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)
Time frame: Perioperative: entering the operating room, before induction of anesthesia, before intubation, immediately after intubation, start of surgery, end of surgery, at extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Background: PubMed 38560523Xu 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.
- Background: PubMed 39064818Hung 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.
- Background: PubMed 38108626Kilic 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.
- Background: PubMed 37414272Zhou 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.
- Background: PubMed 37267129Yan 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.
- Background: PubMed 37267303Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xie chenglan, PhD study director
The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Esketamine, Magnesium sulfate and Saline 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 8 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: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hospital Anxiety and Depression Scale (time frame: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 3 (POD3)). The study lists 4 primary outcomes in all. 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 NCT06920576, which also lists 6 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 10 Apr 2025.