The Effect of Esketamine on Patients Undergoing Tumor Surgery

Study Overview
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Brief Summary
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Although the acute and chronic postoperative pain of surgical patients has gradually been paid attention to, it has not yet been better resolved.and, the incidence of anxiety and depression in cancer patients is constantly increasing，The new analgesic anesthetic esketamine hydrochloride was launched in China last year，however, in the domestic and foreign literature, there are still few reports of esketamine hydrochloride in postoperative analgesia, and most of them are retrospective and small samples.This study aims to investigate whether esketamine has advantages over traditional opioids in terms of postoperative analgesia, anxiety and depression in cancer patients.

Official Title
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Effects of Esketamine on Postoperative Pain, Anxiety and Depression in Patients Undergoing Tumor Surgery

Conditions
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Tumor Surgery

Intervention / Treatment
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* Drug: High-dose Esketamine hydrochloride+Hydromorphone
* Drug: Low-dose Esketamine hydrochloride+Hydromorphone
* Drug: Hydromorphone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old; Patients undergoing elective tumor surgery Use intravenous analgesia pump (PCIA) after operation Exclusion Criteria: Patients with severe infection or respiratory system diseases; Severe arrhythmia, unstable angina or myocardial infarction, heart failure; Patients with severe diseases of liver, kidney, endocrine or immune system; ·Patients with fever before operation; One month before operation Patients receiving chemotherapy, radiotherapy or immunotherapy; Drug or alcohol dependence; Mental illness, disturbance of consciousness and communication difficulties or inability to understand the questionnaire or refusal to complete; Long-term use of antidepressant and anxiety drugs; High intracranial pressure High intraocular pressure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose esketamine group<br>After the operation, 5 mg esketamine was injected intravenously for postoperative analgesia. PCIA formula: hydromorphone 6mg + esketamine 45mg + tropisetron 10mg into 0.9% sodium chloride injection 100ml, the first dose is 20ug/kg , Background dose 2ug/kg/h, single dose 4ug/kg/time | Drug: High-dose Esketamine hydrochloride+Hydromorphone<br>* By adding different doses of esketamine to the postoperative analgesic pump, and the control group without adding this drug to observe the postoperative pain, anxiety and depression indicators of the surgical patients<br>|
| Experimental: Low-dose esketamine group<br>After the operation, esketamine 2.5mg was injected intravenously for postoperative analgesia. PCIA formula: hydromorphone 6mg + esketamine 22.5mg + tropisetron 10mg into 0.9% sodium chloride injection 100ml, the first dose is 20ug/ kg, background dose 2ug/kg/h, single dose 4ug/kg/time | Drug: Low-dose Esketamine hydrochloride+Hydromorphone<br>* By adding different doses of esketamine to the postoperative analgesic pump, and the control group without adding this drug to observe the postoperative pain, anxiety and depression indicators of the surgical patients<br>|
| Placebo Comparator: Control group<br>PCIA formula: 6mg of hydromorphone + 10mg of tropisetron into 100ml of 0.9% sodium chloride injection, the first dose is 20ug/kg, the background dose is 2ug/kg/h, and the single dose is 4ug/kg/time. | Drug: Hydromorphone<br>* No esketamine added<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of moderate to severe pain | Visual analog score is 4 points or more | Within 72 hours after surgery | 
| Pain score | Visual analog scale | Within 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions | Nausea, vomiting, lethargy, mental symptoms, etc. | Within 72 hours after surgery | 
| Postoperative analgesia | PCIA usage（ml）, PCIA compressions（frequency）, remedial analgesia measures（Name and dosage of intravenous analgesics） | Within 48 hours after surgery | 
| Sedation | Ramsay sedation score（The score is 1-6 points, the higher the score, the higher the degree of sedation, the ideal sedation score is 2 points） | Within 48 hours after surgery | 
| Anxiety | Hamilton Anxiety Scale（There are a total of 14 options. Each item is divided into 0-4 points according to the degree, and the score is 0-56 points. The total score is ≥29 points, which may be severe anxiety; ≥21 points, there must be obvious anxiety; ≥14 points, there must be Anxiety; more than 7 points, there may be anxiety; if less than 7, there are no anxiety symptoms.） | Baseline (Before operation), 24 hours after operation, 72 hours after operation | 
| Depression | Hamilton Depression Scale（There are a total of 17 options, and each item is divided into 0-4 points or 0-2 points according to the degree. The total score is less than 7 points: normal; the total score is 7 17 points: there may be depression; the total score is 17 24 points : There must be depression; total score> 24 points: severe depression） | Baseline (Before operation), 24 hours after operation, 72 hours after operation | 
| Sleep condition | Sleep quality（Self-assessment by the patient, the score is 1-5 points, the higher the score, the better the sleep） | Within 72 hours after surgery | 
| Chronic pain | Chronic pain conversion rate（Follow-up one month after surgery, if there are still pain symptoms, it is chronic pain） | One month after surgery |