The Effect of Esketamine on Patients Undergoing Tumor Surgery

Zhejiang University

Status: Unknown

Conditions: Tumor Surgery

Treatments: Drug: Low-dose Esketamine hydrochloride+Hydromorphone; Drug: Hydromorphone; Drug: High-dose Esketamine hydrochloride+Hydromorphone

Study type: Interventional

Funder types: Other

Identifiers

NCT04613869

2020-818

Details and patient eligibility

About

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.

Enrollment: 282 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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282 participants in 3 patient groups, including a placebo group

High-dose esketamine group

Experimental group

Description:

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

Treatment:

Drug: High-dose Esketamine hydrochloride+Hydromorphone

Low-dose esketamine group

Experimental group

Description:

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

Treatment:

Drug: Low-dose Esketamine hydrochloride+Hydromorphone

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Hydromorphone