The Effect of Esketamine on Patients Undergoing Tumor Surgery

NCT04613869 | Unknown DMC

• 1 other identifier: 2020-818
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Adverse reactions

  Within 72 hours after surgery

• Postoperative analgesia

  Within 48 hours after surgery

• Sedation

  Within 48 hours after surgery

• Anxiety

  Baseline (Before operation), 24 hours after operation, 72 hours after operation

• Depression

  Baseline (Before operation), 24 hours after operation, 72 hours after operation

Study Arms (3)

High-dose esketamine group

EXPERIMENTAL

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

Low-dose esketamine group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

High-dose Esketamine hydrochloride+Hydromorphone 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

High-dose esketamine group

Low-dose Esketamine hydrochloride+Hydromorphone 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

Hydromorphone DRUG

No esketamine added

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old;
• Patients undergoing elective tumor surgery
• Use intravenous analgesia pump (PCIA) after operation

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Hydromorphone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Min Yan, Doctor

  Zhejiang University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 3, 2020
• Study Start: August 15, 2020
• Primary Completion: August 15, 2021
• Study Completion: October 15, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)