Efcacy and safety of esketamine combined with propofol in painless gastroscopy

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300070635

Enrollment

Unknown

Registered

2023-04-19

Start date

2023-04-19

Completion date

Unknown

Last updated

2023-06-04

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

Conditions

painless gastroscopy

Interventions

Part 1: esketamine+propofol:Esketamine was administered sequentially by a up-and-down method with an initial dose of 0.2mg/kg and propofol 1.5mg/kg

Part 2: esketamine+propofol

sufentanil+propofol:esketamine(ED95 from part 1)+propofol(1.5mg/kg)

Part 2: sufentanil+propofol:sufentanil 0.1µg/kg+propofol 1.5mg/kg

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)American Society of Anesthesiologists, ASA graded I-III;(2)Aged 18-65 years old;(3)BMI<30 kg/m2

Exclusion criteria

Exclusion criteria: (1) Allergic history of propofol, esketamine or allergic to narcotic drugs; (2) Patients with a history of serious heart, lung, brain, liver or kidney disease; (3) Patients with hypertension, glaucoma or elevated intracranial pressure; (4) Patients with central nervous system disease, history of mental illness, mental illness or preoperative cognitive dysfunction; (5) Long-term use of sedative hypnotic drugs or sedative analgesic drugs; (6) Patients with difficult airway, COPD, acute upper respiratory tract infection, asthma attack or acute severe laryngeal disease (7) Refuse to sign the informed consent.

Design outcomes

Primary

Measure	Time frame
Part One: Negative/Positive reactions;Part 2: Cardiopulmonary Adverse Events (hypoxemia, respiratory depression and suspension, arrhythmias, bradycardia and tachycardia);	—

Secondary

Measure	Time frame
Part 1: Blood pressure, heart rate, pulse oxygen saturation; The occurrence of hypoxemia, hypotension, bradycardia, respiratory depression, postoperative dizziness, psycho-related symptoms and dreaming; Total dosage of propofol, gastroscopy time, anesthesia recovery time and sleep satisfaction;Part 2: Record the total amount of propofol, gastroscopy time, anesthesia induction time, anesthesia recovery time, sleep satisfaction, postoperative dizziness, mental symptoms and dreams;	—

Measure

Time frame

Part 1: Blood pressure, heart rate, pulse oxygen saturation; The occurrence of hypoxemia, hypotension, bradycardia, respiratory depression, postoperative dizziness, psycho-related symptoms and dreaming; Total dosage of propofol, gastroscopy time, anesthesia recovery time and sleep satisfaction;Part 2: Record the total amount of propofol, gastroscopy time, anesthesia induction time, anesthesia recovery time, sleep satisfaction, postoperative dizziness, mental symptoms and dreams;

—

Countries

China

Contacts

Public ContactHai-Xia Wang

Beijing Friendship Hospital, Capital Medical University

wanghaixia1221@126.com+86 18801239620

Outcome results

None listed

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