Postoperative PainPhase 4NCT07063108
Efficacy and Safety of S-ketamine in Elderly Patients Undergoing Non-cardiac Surgery: a RCT（ESSENCE）
A Phase 4 study testing Esketamine hydrochloride and Saline in people with Postoperative Pain, run by Chinese PLA General Hospital.
Trial summary
This national, multi-center, randomized controlled study, through the study of intravenous injection of estaketamine in elderly patients undergoing surgery, is expected to explore whether estaketamine can improve the acute postoperative pain of elderly patients undergoing surgery and reduce the incidence of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Esketamine hydrochloride and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1) Aged > 65 years old, no gender limitation;
- 2) patients undergoing elective thoracic, abdominal and orthopedic surgery;
- 3) ASA score is Class I-Class ~III;
- 4) 18 kg/ m2<BMI<30kg/m2；
- 5) The operation time is estimated to be 2 h-4 h;
- 6) Know clearly and voluntarily participate in this study, and sign informed consent form by oneself.
Who cannot join
- 1) patients with severe chronic pain;
- 2) Anemia or thrombocytopenia, Hb < 90 g/L, PLT < 80 × 109/L;
- 3) Severe liver dysfunction, AST and/or ALT≥2.5×ULN, and TBIL ≥ 1.5 × ULN;
- 4) severe renal dysfunction, blood creatinine is greater than the upper limit of normal;
- 5) Severe cardiovascular history (such as myocardial ischemia, heart failure and arrhythmia); Angina pectoris (unstable angina pectoris) caused by insufficient blood supply to the coronary vessels of the heart, or myocardial infarction in the past 6 months; QT interval prolongation (≥460ms in males and ≥ 470 ms in females);
- 6) Patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive drugs (systolic blood pressure in sitting position during screening stage ≥180 mmHg, and/or diastolic blood pressure during screening stage ≥ 100 mmHg);
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- 7) Patients with craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident history and central nervous system disease history;
- 8) patients with glaucoma or serious increase in intraocular pressure risk;
- 9) patients with mental system diseases (schizophrenia, mania, bipolar disorder, mental disorder, etc.) and drug history and cognitive dysfunction; History of cognitive psychiatric disorders such as postoperative delirium; Pregnant or lactating women;
- 10) high risk surgery, is expected to enter the ICU after surgery;
- 11) to moxa ketamine hydrochloride and its drug components allergy or taboo;
- 12) Being a subject and having participated in clinical trials for other drugs in the past three months;
- 13) There is communication disorder;
- 14) Patients considered by the investigator to be ineligible for participation in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of S-ketamine Hydrochloride Injection in Elderly Patients Undergoing Elective Non-cardiac Surgery: a Multicenter, Randomized, Placebo Controlled Clinical Trials（ESSENCE）
This national, multi-center, randomized controlled study, through the study of intravenous injection of estaketamine in elderly patients undergoing surgery, is expected to explore whether estaketamine can improve the acute postoperative pain of elderly patients undergoing surgery and reduce the incidence of postoperative depression and delirium.
- Conditions
- Postoperative Pain
- Being tested
- Esketamine hydrochloride, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine hydrochlorideDrug
Intravenous infusion of esketamine: after induction, a single dose of 0.25 mg/kg before skin incision，and continuous 0.125 mg/kg/h until 30 min before surgery was stopped.
SalineDrug
after induction, a single intravenous infusion of an equal amount of 0.9% saline before skin incision, followed by a continuous infusion at the same rate as the test group until 30 min before surgical cessation.
| Study group | Role | What they receive |
|---|---|---|
| Test group (esketamine injection) | Experimental | Test group (esketamine injection group)： Intravenous infusion of esketamine: after induction, a single dose of 0.25 mg/kg before skin incision，and continuous 0.125 mg/kg/h until 30 min before surgery was stopped. Receives: Drug: Esketamine hydrochloride |
| Control group (placebo: saline) | Placebo comparator | Control group (placebo: saline): after induction, a single intravenous infusion of an equal amount of 0.9% saline before skin incision, followed by a continuous infusion at the same rate as the test group until 30 min before surgery was stopped. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS pain score at the 24th hour after operation.
NRS pain score at the 24th hour after operation.
Measured: 24th hour after operation
Secondary outcomes (7)
NRS pain scores at the 2nd hour, 48th hour and 72nd hour after operation.
NRS pain scores at the 2nd hour, 48th hour and 72nd hour after operation.
Measured: the 2nd hour, 48th hour and 72nd hour after operation.
The evaluation of APS-POQ-R questionnaire at 24 hours, 48 hours and 72 hours after operation.
The evaluation of APS-POQ-R questionnaire at 24 hours, 48 hours and 72 hours after operation.
Measured: 24 hours, 48 hours and 72 hours after operation.
The consumption of anesthetic and analgesic drugs during and within 72 hours after operation.
Measured: during and within 72 hours after operation.
The scores of Montgomery Depression Scale at 24th hour, 48th hour and 72nd hour after operation.
Measured: 24th hour, 48th hour and 72nd hour after operation.
The score of GAD-7 anxiety scale 72 hours after operation. The incidence of delirium within 72 hours after operation
Measured: 72 hours after operation
The incidence of delirium within 72 hours after operation
Measured: 72 hours after operation
The incidence of adverse events during and within 72 hours after operation.
Measured: 72 hours after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063108
- Sponsor's protocol ID
- 2022-698
- Status last verified
- Jul 2025
- First submitted
- 27 Nov 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of S-ketamine Hydrochloride Injection in Elderly Patients Undergoing Elective Non-cardiac Surgery: a Multicenter, Randomized, Placebo Controlled Clinical Trials（ESSENCE）
- ClinicalTrials.gov ID
- NCT07063108
- Acronym / sponsor ID
- 2022-698
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jul 2025 (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.
This national, multi-center, randomized controlled study, through the study of intravenous injection of estaketamine in elderly patients undergoing surgery, is expected to explore whether estaketamine can improve the acute postoperative pain of elderly patients undergoing surgery and reduce the incidence of postoperative depression and delirium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group (esketamine injection) | Experimental | Drug: Esketamine hydrochlorideTest group (esketamine injection group)： Intravenous infusion of esketamine: after induction, a single dose of 0.25 mg/kg before skin incision，and continuous 0.125 mg/kg/h until 30 min before surgery was stopped. |
| Control group (placebo: saline) | Placebo comparator | Drug: SalineControl group (placebo: saline): after induction, a single intravenous infusion of an equal amount of 0.9% saline before skin incision, followed by a continuous infusion at the same rate as the test group until 30 min before surgery was stopped. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 1) Aged > 65 years old, no gender limitation;
- 2) patients undergoing elective thoracic, abdominal and orthopedic surgery;
- 3) ASA score is Class I-Class ~III;
- 4) 18 kg/ m2<BMI<30kg/m2；
- 5) The operation time is estimated to be 2 h-4 h;
Key exclusion criteria (14 listed)
- 1) patients with severe chronic pain;
- 2) Anemia or thrombocytopenia, Hb < 90 g/L, PLT < 80 × 109/L;
- 3) Severe liver dysfunction, AST and/or ALT≥2.5×ULN, and TBIL ≥ 1.5 × ULN;
- 4) severe renal dysfunction, blood creatinine is greater than the upper limit of normal;
- 5) Severe cardiovascular history (such as myocardial ischemia, heart failure and arrhythmia); Angina pectoris (unstable angina pectoris) caused by insufficient blood supply to the coronary vessels of the heart, or myocardial infarction in the past 6 months; QT interval prolongation (≥460ms in males and ≥ 470 ms in females);
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 |
|---|---|---|
| Esketamine hydrochlorideIntravenous infusion of esketamine: after induction, a single dose of 0.25 mg/kg before skin incision，and continuous 0.125 mg/kg/h until 30 min before surgery was stopped. | Drug | Test group (esketamine injection) |
| Salineafter induction, a single intravenous infusion of an equal amount of 0.9% saline before skin incision, followed by a continuous infusion at the same rate as the test group until 30 min before surgical cessation. | Drug | Control group (placebo: saline) |
Primary outcome
NRS pain score at the 24th hour after operation.
Time frame: 24th hour after operation
NRS pain score at the 24th hour after operation.
7 secondary outcomes
NRS pain scores at the 2nd hour, 48th hour and 72nd hour after operation.
Time frame: the 2nd hour, 48th hour and 72nd hour after operation.
The evaluation of APS-POQ-R questionnaire at 24 hours, 48 hours and 72 hours after operation.
Time frame: 24 hours, 48 hours and 72 hours after operation.
The consumption of anesthetic and analgesic drugs during and within 72 hours after operation.
Time frame: during and within 72 hours after operation.
The scores of Montgomery Depression Scale at 24th hour, 48th hour and 72nd hour after operation.
Time frame: 24th hour, 48th hour and 72nd hour after operation.
The score of GAD-7 anxiety scale 72 hours after operation. The incidence of delirium within 72 hours after operation
Time frame: 72 hours after operation
The incidence of delirium within 72 hours after operation
Time frame: 72 hours after operation
The incidence of adverse events during and within 72 hours after operation.
Time frame: 72 hours after operation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine hydrochloride and Saline in people with Postoperative Pain, run by Chinese PLA General Hospital.
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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoying Zhang (+8613021919086, zxystudy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS pain score at the 24th hour after operation. (time frame: 24th hour after operation). 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 14 Jul 2025.