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The Effect of Esketamine on Patients Undergoing Tumor Surgery

NCT ID: NCT04613869

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2021-10-15

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.

Detailed Description

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Conditions

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Tumor Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High-dose esketamine group

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

Group Type EXPERIMENTAL

High-dose Esketamine hydrochloride+Hydromorphone

Intervention Type DRUG

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

Low-dose esketamine group

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

Group Type EXPERIMENTAL

Low-dose Esketamine hydrochloride+Hydromorphone

Intervention Type DRUG

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

Control group

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.

Group Type PLACEBO_COMPARATOR

Hydromorphone

Intervention Type DRUG

No esketamine added

Interventions

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High-dose Esketamine hydrochloride+Hydromorphone

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

Intervention Type DRUG

Low-dose Esketamine hydrochloride+Hydromorphone

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

Intervention Type DRUG

Hydromorphone

No esketamine added

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Yan, Doctor

Role: STUDY_DIRECTOR

Zhejiang University

Locations

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The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2020-818

Identifier Type: -

Identifier Source: org_study_id