The Effect of Esketamine on Patients Undergoing Tumor Surgery

Tumor Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04613869
• Other study ID #: 2020-818
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: October 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 282
• Est. completion date: October 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tumor Surgery

Intervention

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
• 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
• Hydromorphone
No esketamine added

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of moderate to severe pain	Visual analog score is 4 points or more	Within 72 hours after surgery
Primary	Pain score	Visual analog scale	Within 72 hours after surgery
Secondary	Adverse reactions	Nausea, vomiting, lethargy, mental symptoms, etc.	Within 72 hours after surgery
Secondary	Postoperative analgesia	PCIA usage(ml), PCIA compressions(frequency), remedial analgesia measures(Name and dosage of intravenous analgesics)	Within 48 hours after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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