Skip to content

Safety and Efficacy of Application of Sub-Anesthesia Doses of Esketamine Combined With Propofol in Painless Gastrointestinal Endoscopy: a Double-Blind, Randomized, Controlled Study

Safety and Efficacy of Application of Sub-Anesthesia Doses of Esketamine Combined With Propofol in Painless Gastrointestinal Endoscopy: a Double-Blind, Randomized, Controlled Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039750
Enrollment
Unknown
Registered
2020-11-07
Start date
2020-11-10
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

Painless Gastrointestinal Endoscopy

Interventions

Group P:propofol+saline
Group PK1:propofol+Esketamine 0.05mg/kg
Group PK2:propofol+Esketamine 0.1mg/kg
Group PK3:propofol+Esketamine 0.2mg/kg

Sponsors

The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 60 years; 2. BMI18kg/m^2-30 kg/m^2; 3. ASA class for I-II; 4. Planing to receive gastrointestinal endoscopy; 5. The patient or family member fully understood the purpose and significance of this experiment, volunteered to participate in this clinical trial, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Diabetic patients (random blood glucose in the screening period is greater than 11.1 mmlol/L) hypertension patients (blood pressure is higher than 160mmHg) or hypotention (Systolic pressure is less than 90 mmHg); 2. There was a history of myocardial infarction and unstable angina in 6 months; 3. There was a history of bradycardia (heart rate 50 times per minute or less), III degree atrioventricular block (use of pacemaker patients), and other serious arrhythmia; 4. Patients with severe snoring ,sleep apnea syndrome or other serious respiratory disease; 5. Abnormal liver function, ALT or AST > 2 times normal value upper limit;Total bilirubin > 1.5 times normal value upper limit; 6. Renal function abnormality, blood creatinine (cr) and/or urea nitrogen (BUN) > 1.5 times normal value upper limit;Dialysis patients; 7. Neurological dysfunction,mental disorders or cognitive dysfunction; 8. There was a history of psycho-drug abuse and drug abuse; 9. Patients who are allergic to the drugs used in this study or in the range of drug contraindications; 10. Participate in other drug clinical trials within 3 months; 11. The investigators determined that the patients were not eligible for other conditions in the clinical trial.

Design outcomes

Primary

MeasureTime frame
propofol consumption per minute;

Secondary

MeasureTime frame
Blood Pressure;Heart Rate;SPO2;Procedure time;induction time;awakening time;Time to ambulate;incidence of bucking or coughing;incidence of body movement;Incidence of injection pain;

Countries

China

Contacts

Public ContactYalan Li

The First Affiliated Hospital of Jinan University

744897863@qq.com+86 13500013993

Outcome results

None listed

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