Tumor SurgeryNCT04613869
The Effect of Esketamine on Patients Undergoing Tumor Surgery
A study testing High-dose Esketamine hydrochloride+Hydromorphone, Low-dose Esketamine hydrochloride+Hydromorphone and Hydromorphone in people with Tumor Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tumor Surgery
- What is being tested?
- High-dose Esketamine hydrochloride+Hydromorphone, Low-dose Esketamine hydrochloride+Hydromorphone and Hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2020to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old;
- Patients undergoing elective tumor surgery
- Use intravenous analgesia pump (PCIA) after operation
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
About this study
Official title: 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.
- Conditions
- Tumor Surgery
- Being tested
- High-dose Esketamine hydrochloride+Hydromorphone, Low-dose Esketamine hydrochloride+Hydromorphone, Hydromorphone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose Esketamine hydrochloride+HydromorphoneDrug
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+HydromorphoneDrug
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
HydromorphoneDrug
No esketamine added
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate to severe pain
Visual analog score is 4 points or more
Measured: Within 72 hours after surgery
Pain score
Visual analog scale
Measured: Within 72 hours after surgery
Secondary outcomes (7)
Adverse reactions
Nausea, vomiting, lethargy, mental symptoms, etc.
Measured: Within 72 hours after surgery
Postoperative analgesia
PCIA usage（ml）, PCIA compressions（frequency）, remedial analgesia measures（Name and dosage of intravenous analgesics）
Measured: 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）
Measured: 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.）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start15 Aug 2020
- Primary completion15 Aug 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor SurgeryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Yan, Doctor, Study director, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613869
- Sponsor's protocol ID
- 2020-818
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Esketamine on Postoperative Pain, Anxiety and Depression in Patients Undergoing Tumor Surgery
- ClinicalTrials.gov ID
- NCT04613869
- Acronym / sponsor ID
- 2020-818
- Conditions
- Tumor Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose esketamine group | Experimental | Drug: High-dose Esketamine hydrochloride+HydromorphoneAfter 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 |
| Low-dose esketamine group | Experimental | Drug: Low-dose Esketamine hydrochloride+HydromorphoneAfter 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 |
| Control group | Placebo comparator | Drug: HydromorphonePCIA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old;
- Patients undergoing elective tumor surgery
- Use intravenous analgesia pump (PCIA) after operation
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose Esketamine hydrochloride+HydromorphoneBy 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 | Drug | High-dose esketamine group |
| Low-dose Esketamine hydrochloride+HydromorphoneBy 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 | Drug | Low-dose esketamine group |
| HydromorphoneNo esketamine added | Drug | Control group |
Primary outcome
Incidence of moderate to severe pain
Time frame: Within 72 hours after surgery
Visual analog score is 4 points or more
Pain score
Time frame: Within 72 hours after surgery
Visual analog scale
7 secondary outcomes
Adverse reactions
Time frame: Within 72 hours after surgery
Postoperative analgesia
Time frame: Within 48 hours after surgery
Sedation
Time frame: Within 48 hours after surgery
Anxiety
Time frame: Baseline (Before operation), 24 hours after operation, 72 hours after operation
Depression
Time frame: Baseline (Before operation), 24 hours after operation, 72 hours after operation
Sleep condition
Time frame: Within 72 hours after surgery
Chronic pain
Time frame: One month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Yan, Doctor study director
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose Esketamine hydrochloride+Hydromorphone, Low-dose Esketamine hydrochloride+Hydromorphone and Hydromorphone in people with Tumor Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of moderate to severe pain (time frame: Within 72 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.