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Randomized controlled clinical study on the efficacy and safety of HSK3486 in induction of general anesthesia in tumor patients

Randomized controlled clinical study on the efficacy and safety of HSK3486 in induction of general anesthesia in tumor patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066719
Enrollment
Unknown
Registered
2022-12-14
Start date
2022-11-09
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Thyroid cancer, breast cancer

Interventions

HSK3486:Cyclopofol induction, failed to add propofol
Propofol group:Propofol induction, failed to add propofol

Sponsors

Affiliated Cancer Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-70, gender unlimited; (2) American Society of Anesthesiologists (ASA) grade I-II; (3) patients with thyroid or breast tumors requiring tracheal intubation general anesthesia for elective surgery; (4) Body mass index (BMI) =18 and =30kg/m2; (5) Vital signs: respiratory rate =10 and =24 times/min; Blood oxygen saturation (SpO2) =95% when breathing air; Systolic blood pressure (SBP) =90mmHg and =160mmHg; Diastolic blood pressure (DBP) =60mmHg and =100mmHg; Heart rate =55 and =100 beats/min; (6) Be able to understand the research process and methods, and voluntarily participate in the research.

Exclusion criteria

Exclusion criteria: (1) Patients with contraindications to general anesthesia or with a history of anesthesia accidents; (2) Known or suspected allergic or contraindicated to propofol injection, HSK3486 excipients, benzodiazepines, opioids, muscle relaxants, etc.; (3) Patients complicated with craniocerebral loss, intracranial hypertension, stroke, unstable angina pectoris, myocardial infarction; (4) Respiratory insufficiency, obstructive pulmonary disease, presence of a difficult airway, or determination of difficulty intubating (modified Marschner score Level III or IV) (5) uncontrolled diabetes or hypertension; (6) severe liver dysfunction or severe renal insufficiency; (7) A history of alcoholism or drug dependence; (8) Abuse or long-term use of narcotic, sedative and analgesic drugs; (9) previous history of mental illness; (10) Participants in any drug clinical trials within 1 month before screening; (11) Pregnant and lactating women; Fertile women or men were reluctant to use contraception throughout the trial; Subjects (including male subjects) who plan to become pregnant within 1 month after the trial; (12) Subjects with any other factors deemed unsuitable by the investigator for participation in this study.

Design outcomes

Primary

MeasureTime frame
Success rate of induction of anesthesia;Heart rate;Brain dual-frequency index;

Secondary

MeasureTime frame
Evaluation of injection pain;The incidence was known intraoperatively;

Countries

china

Contacts

Public Contactshenglin pei

Affiliated Cancer Hospital of Guangxi Medical University

peishenglin@gxmu.edu.cn15278017977

Outcome results

None listed

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