Skip to content

Safety and efficacy evaluation of S(+)-ketamine for Postoperative acute pain in adults in perioperative settings: a multicenter, randomized, open-label, active controlled pragmatic clinical trial (SAFE-SK-A)

Safety and efficacy evaluation of S(+)-ketamine for Postoperative acute pain in adults in perioperative settings: a multicenter, randomized, open-label, active controlled pragmatic clinical trial (SAFE-SK-A)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052593
Enrollment
Unknown
Registered
2021-11-01
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute postoperative pain

Interventions

experimental group:Esketamine injection was used in the perioperative period
control group:Esketamine hydrochloride injection was not used during perioperative period

Sponsors

The General Hospital of the People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. Plan to carry out selective general anesthesia, lower gastrointestinal surgery, gynecological surgery, urological surgery, thoracic surgery, orthopedic limb surgery, orthopedic spine surgery or surface surgery (thyroid or breast surgery), head and neck surgery; 3. ASA score I-III; 4. Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. Expected hospital stay < 48h; 2. Patients who are expected to enter ICU after surgery; 3. Patients who are expected to return to the ward with a tracheal tube after the operation; 4. Those who are known to be allergic to the active ingredients or excipients of esketamine hydrochloride injection; 5. Patients with severe disturbance of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, mental confusion, etc.) and cognitive dysfunction; 6. A history of severe cardiovascular disease (congestive heart failure, severe angina pectoris, or unstable angina or myocardial infarction occurred within 6 months); 7. Patients during pregnancy or lactation; 8. Patients with MMSE score <18 points; 9. Patients who have any of the following contraindications for esketamine injection: (1) Patients who are at serious risk of increased blood pressure or intracranial pressure; (2) Patients with high intraocular pressure (glaucoma) or penetrating eye trauma; (3) Poorly controlled or untreated hypertensive patients (arterial hypertension, resting systolic blood pressure exceeding 180 mmHg, or resting diastolic blood pressure exceeding 100 mmHg); (4) Patients with untreated or undertreated hyperthyroidism (hyperthyroidism).

Design outcomes

Primary

MeasureTime frame
Vital signs and physical examination;Pain assessment;Depression/anxiety assessment;Delirium assessment;Cognitive function assessment;laboratory examination;

Countries

China

Contacts

Public ContactLi Mingqiang

Xiangyang Central Hospital

limq06@126.com+86 13986344849

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026