The Effect of Esketamine on Patients Undergoing Tumor Surgery

Not Applicable

• Conditions: Tumor Surgery
• Interventions: Drug: High-dose Esketamine hydrochloride+Hydromorphone; Drug: Low-dose Esketamine hydrochloride+Hydromorphone; Drug: Hydromorphone

• Registration Number: NCT04613869
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-15
• Status Verified: 2020-10
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-01
• Last Update Submitted: 2020-11-01
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03
• Primary Completion: 2021-08-15
• Study Completion: 2021-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 282

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose esketamine group	High-dose Esketamine hydrochloride+Hydromorphone	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
Low-dose esketamine group	Low-dose Esketamine hydrochloride+Hydromorphone	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
Control group	Hydromorphone	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.

Primary Outcome Measures

Name	Time	Method
Pain score	Within 72 hours after surgery	Visual analog scale
Incidence of moderate to severe pain	Within 72 hours after surgery	Visual analog score is 4 points or more

Secondary Outcome Measures

Name	Time	Method
Sleep condition	Within 72 hours after surgery	Sleep quality（Self-assessment by the patient, the score is 1-5 points, the higher the score, the better the sleep）
Chronic pain	One month after surgery	Chronic pain conversion rate（Follow-up one month after surgery, if there are still pain symptoms, it is chronic pain）
Postoperative analgesia	Within 48 hours after surgery	PCIA usage（ml）, PCIA compressions（frequency）, remedial analgesia measures（Name and dosage of intravenous analgesics）
Adverse reactions	Within 72 hours after surgery	Nausea, vomiting, lethargy, mental symptoms, etc.
Sedation	Within 48 hours after surgery	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）
Anxiety	Baseline (Before operation), 24 hours after operation, 72 hours after operation	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.）
Depression	Baseline (Before operation), 24 hours after operation, 72 hours after operation	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）

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department; 🇨🇳 Hangzhou, Zhejiang, China