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Single center randomized controlled study on the safety and effectiveness of disodium propofol for painless gastroscopy

Single center randomized controlled study on the safety and effectiveness of disodium propofol for painless gastroscopy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073221
Enrollment
Unknown
Registered
2023-07-04
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-10

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 1:Propofol disodium phosphate 6.5mg/kg
Group 2:Propofol disodium phosphate 10mg/kg
Group 3:Propofol disodium phosphate 12.5mg/kg
Group 4:Propofol disodium phosphate 15mg/kg
Group 5:Propofol disodium phosphate 18mg/kg

Sponsors

Weifang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients who intend to undergo gastrointestinal endoscopy; (2) 18-65 years old, no gender limit; (3) Body mass index (BMI) 18.5~30kg/m2; (4) The American Association of Anesthesiologists (ASA) graded ?~?. (5) Inspection time within 30min

Exclusion criteria

Exclusion criteria: (1) Patients who refuse to participate in the trial (2) Those with a history of serious heart, brain, lung, liver, kidney and metabolic diseases; (3) Those who have a history of abnormal surgical anesthesia recovery; (4) ECG prompt: heart rate 180mmHg and (or) diastolic blood pressure >110mmHg, or hypotension patients <90/60mmHg; (7) Those with neuromuscular system disease or mental illness; (8) Anemia patients; (9) Suspected of abusing narcotic analgesics or tranquilizers; (10) Those who predict that a difficult airway may or have occurred; (11) Those who are known to have a history of drug allergy, allergic diseases, or allergic constitutions; (12) Those who do not cooperate and cannot communicate

Design outcomes

Primary

MeasureTime frame
Patient Vital Signs:Blood pressure (BP), heart rate (HR), pulse oxygen saturation (SpO2), respiratory rate (RR);Patient sedation success rate;Intraoperative adverse reactions: body movements, hypotension, hypoxia, respiratory depression, apnoea, choking, abnormal sensations, pruritus, painful injections;Post-operative adverse effects: vertigo, nausea and vomiting;

Secondary

MeasureTime frame
Patient's basic information;Time from the start of anaesthesia to the start of the examination;Time for the eyelash reflex to disappear;Surgery time;Wake up time;

Countries

China

Contacts

Public ContactJi Fanceng

Weifang People's Hospital

jifanceng@163.com+86 135 6369 8838

Outcome results

None listed

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