The Effect of Esketamine on Patients Undergoing Tumor Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Tumor Surgery
• Intervention / Treatment: Drug: High-dose Esketamine hydrochloride+Hydromorphone; Drug: Low-dose Esketamine hydrochloride+Hydromorphone; Drug: Hydromorphone

• Study Type: Interventional
• Enrollment (Anticipated): 282
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University anesthesiology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: 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
EXPERIMENTAL: 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	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
PLACEBO_COMPARATOR: 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.	Drug: Hydromorphone; No esketamine added

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2020
• Primary Completion (ANTICIPATED): August 15, 2021
• Study Completion (ANTICIPATED): October 15, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (ACTUAL): November 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Antidepressive Agents; Esketamine; Hydromorphone
• Other Study ID Numbers: 2020-818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No