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Application of Conscious Sedation for Gastroscopy: a Randomized Controlled Trial

Application of Conscious Sedation for Gastroscopy: a Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053142
Enrollment
Unknown
Registered
2021-11-13
Start date
2021-11-22
Completion date
Unknown
Last updated
2022-09-20

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

Conditions

Painless gastroscopy in patients at high risk of aspiration

Interventions

O group:Intravenous injection oxycodone
N group:Inject normal saline

Sponsors

The Third Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 80 years, ASA grade I-III, 18 <= BMI <= 30; 2.Patients requiring gastroscopy and at high risk of vomiting and aspiration; 3.Be conscious, able to understand and sign informed consent voluntarily; 4.Gastroscopy should be completed within 10 minutes.

Exclusion criteria

Exclusion criteria: 1.Severe hepatic and renal insufficiency; 2.Patients requiring endoscopic treatment; 3.No sedation, hypnosis, anesthesia, analgesia, muscle relaxation or other drugs were used 1 month before surgery; 4.Central nervous system diseases; Mental system diseases (schizophrenia, mania, insanity, etc.) and long-term use of sedatives or analgesics; 5.Patients with a history of craniocerebral injury and/or cerebrovascular accident; There may be intracranial hypertension and cerebral aneurysm; 6.Associated with infectious heart diseases such as myocarditis or endocarditis; Sepsis; 7.Heart failure (NYHA grade III-IV); Unstable angina pectoris; Myocardial infarction occurred within 6 months prior to screening; Resting ecg heart rate = 450ms, female >= 470ms; 8.Patients with various types of shock; 9.Other circumstances deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
The success rate of endoscopy was checked by gastroscopy;

Secondary

MeasureTime frame
Number of gastroscopic intakes;Operation time;Behavioral pain scale score;Total consumption of propofol;Satisfaction scores of patients and endoscopist;Postoperative departure time;Perioperative vital signs;

Countries

China

Contacts

Public ContactChang Huan

The Third Xiangya Hospital, Central South University

64811362@qq.com+86 15973180730

Outcome results

None listed

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