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A randomized controlled clinical study on the efficacy and safety of ciprofol injection for inducing general anesthesia in patients with digestive tract tumor

A randomized controlled clinical study on the efficacy and safety of ciprofol injection for inducing general anesthesia in patients with digestive tract tumor

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048231
Enrollment
Unknown
Registered
2021-07-05
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

None listed

Interventions

Control group:propofol

Sponsors

Wuming Hospital Affiliated to Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years, gender is not limited; 2. American Anesthesiologist Classification (ASA) I-II; 3. Gastrointestinal tumor patients who require tracheal intubation and general anesthesia for elective surgery; 4. Vital signs: respiratory rate >=10 and =95% when breathing air; systolic blood pressure (SBP) >=90mmHg and =60mmHg and =55 and =18 and <=30kg/m^2; 5. Be able to understand the research process and methods, and voluntarily participate in this research.

Exclusion criteria

Exclusion criteria: 1. Those with contraindications to general anesthesia or those who have had a history of anesthesia accident in the past; 2. Known or suspected allergies or contraindications to propofol injection, cyclopofol injection excipients, benzodiazepines, opioids, muscle relaxants, etc.; 3. Combined with craniocerebral loss, intracranial hypertension, stroke, unstable angina, myocardial infarction; 4. Respiratory insufficiency, obstructive pulmonary disease, having a difficult airway, or being judged to have difficulty in endotracheal intubation (modified Markov score grade III or IV) 5. Uncontrolled diabetes or high blood pressure; 6. Severe liver dysfunction or severe renal insufficiency; 7. History of alcoholism or drug dependence; 8. Abuse or long-term use of narcotic, sedative, and analgesic drugs; 9. Those who have a history of mental illness in the past; 10. Those who have participated in any drug clinical trials within 1 month before screening; 11. Pregnant and lactating patients; fertile patients who are unwilling to use contraception throughout the trial period; subjects (including male subjects) who have a pregnancy plan within 1 month after the trial; 12. Patients who are considered by the investigator to have any other factors that are not suitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
Success rate of anesthesia induction;

Secondary

MeasureTime frame
Duration of successful anesthesia induction;Length of disappearance of eyelash reflex;Changes of BIS in EEG;Duration of operation, length of intubation (from the start of intubation to extubation), length of stay in PACU;Study drug and alternative drug use;Satisfaction evaluation of anesthesia induction physicians;Adverse events;Vital signs;Evaluation of injection pain;Intubation response;Incidence of intraoperative awareness;

Countries

China

Contacts

Public ContactChen Xiaoyun

Wuming Hospital Affiliated to Guangxi Medical University

260430941@qq.com+86 18810481573

Outcome results

None listed

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