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Pharmacokinetics study of esketamine hydrochloride injection

Pharmacokinetics and safety of esketamine in patients undergoing painless gastroscopy: a randomized, open-label clinical study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023687
Enrollment
Unknown
Registered
2019-06-07
Start date
2017-06-16
Completion date
Unknown
Last updated
2019-06-11

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

Conditions

Anesthesia, analgesia

Interventions

esketamine group:esketamine 0.5mg/kg
ketamine group:ketamine 1mg/kg

Sponsors

Guo ping Yang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
23 Years to 58 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years old, male:female=1:1; 2. Patients who receive conventional gastroscope treatment; 3. The ASA score is grade I to II; 4. The subject's body mass index (BMI) is between 19.0 and 30.0 kg/m2, including the boundary value; 5. The characteristics, significance, possible benefits, potential risks and discomforts of the trial have been thoroughly understood before the trial, and they have voluntarily participated in this clinical trial, able to communicate well with the researchers, comply with the requirements of the entire study, and signed a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with general anesthesia contraindications; 2. Patients who are allergic to belladonna alkaloids in patients allergic to ketamine hydrochloride, lidocaine hydrochloride, espermone hydrochloride, propofol, opioids, tropisetron hydrochloride, and neostigmine; 3. complex endoscopic techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, or endoscopic muscle dissection) are required; 4. Patients who are scheduled for tracheal intubation; 5. Patients suspected of having gastroduodenal outflow obstruction with retention of contents; 6. Patients suspected of having upper gastrointestinal bleeding; 7. Suffering from severe respiratory disease (obstructive sleep apnea syndrome, open mouth disorder, restricted neck or jaw movement, morbid obesity, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, etc.) patient; 8. The results of vital signs examination, 12-lead ECG and clinical laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function) before screening are judged by the clinician as abnormal and clinically significant; 9. Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), and Treponema pallidum antibody (anti-TP) positive; 10. Abnormal lipid metabolism, including: primary hyperlipidemia, diabetic hyperlipidemia, and pancreatitis; 11. Patients who are judged to have difficulty in respiratory management (modified Markov score is grade IV); 12. pregnant or lactating women, who have a positive pregnancy test during the screening period; 13. craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, history of cerebrovascular accidents, and patients with a history of central nervous system disease; 14. Patients with a history of hyperthyroidism; 15. elevated intraocular pressure (such as glaucoma) or puncture eye damage; 16. Patients with mental illness (schizophrenia, mania, bipolar abnormalities, insanity, etc.) with history and drug history and cognitive dysfunction; 17. Patients with a history of asthma; 18. Those who smoked within 3 months before the test (more than 10 cigarettes or equivalent of tobacco per day in the first month before the test) and cannot quit during the study.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters;

Countries

China

Contacts

Public ContactGuo ping Yang

Third Xiangya Hospital, Central South University

ygp9880@163.com+86 0731-89918665

Outcome results

None listed

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