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Effectiveness and Safety of Cyclopropylphenol vs Propofol for Induction and Maintenance of General Anesthesia in Patients with Thoracolumbar Fractures

Effectiveness and Safety of Cyclopropylphenol for the Induction and Maintenance of General Anesthesia in Patients with Thoracolumbar Fractures

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096445
Enrollment
Unknown
Registered
2025-01-23
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Thoracolumbar Fractures

Interventions

Cyclopropylphenol Group:After the start of induction, the study drug cyclopofol 0.4mg.kg-1 was injected intravenously for a bolus time of 30s. When the patient loses consciousness (LoC), that is, the
Propofol Group:After the start of induction, the study drug propofol 2.0 mg.kg-1 was injected intravenously for a bolus time of 30s. When the patient lost consciousness (LoC), that is, the eyelash ref

Sponsors

Mindong Hospital Affiliated to Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients with thoracic and lumbar vertebra fractures who need to undergo elective surgery for endotracheal intubation; (2) Age 18-65 years old; (3) American Anesthesiologist Classification (ASA) Class I-III; (4) Body mass index (BMI): 18.5-30kg/m^2; (5) Be able to understand the process and methods of this study, and voluntarily participate in this study.

Exclusion criteria

Exclusion criteria: (1) Subjects who explicitly refuse to participate in this study; (2) Those with contraindications to general anesthesia or a history of previous anesthesia accidents; (3) Those who are known or suspected to be allergic or have contraindications to the excipients of propofol injection, cyclopropylphenol injection, benzodiazepines, opioids, muscle relaxants, etc.; (4) Using beta-blockers, anxiolytics, antidepressants; (5) Those suspected of abusing narcotic analgesics or sedatives, as well as alcoholics; (6) Those with a history of severe heart, brain, lung, liver, kidney or metabolic diseases, neuromuscular system diseases (such as myasthenia gravis), or mental illnesses; (7) Uncontrolled diabetes, preoperative systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg, preoperative systolic blood pressure 100 beats/min, or having severe arrhythmia; (9) Having a history of acute respiratory tract infection within 2 weeks and not being cured, having respiratory insufficiency, obstructive pulmonary diseases, having a difficult airway or being judged as having difficult endotracheal intubation (modified Mallampati score of grade III or IV); (10) Those who have participated in any drug clinical trials within 1 month before screening; (11) Pregnant and lactating women; Women or men with fertility who are unwilling to use contraception throughout the trial period; Subjects (including male subjects) who have pregnancy plans within 1 month after the trial; (12) Subjects who are considered by the researchers to have any other factors that are not suitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
Incidence of intraoperative hypotension;

Secondary

MeasureTime frame
Injection pain;Pulse oxygen saturation;Breathe;Heart rate;Time from induction of anesthesia to LoC;The time from the end of maintenance drug administration to eye - opening.;The time from the end of maintenance drug administration to extubation.;The time from the end of maintenance drug administration to leaving the operating room.;Total operation time ;The induction and maintenance doses of cyclopropylphenol/propofol during the operation;The total dose of remifentanil.;The dosage of vasoactive drugs.;The usage situation of rescue medications during the maintenance period.;Modified Observer's Assessment of Alertness/Sedation;Visual Analogue Scale;

Countries

China

Contacts

Public ContactDigui Weng

Mindong Hospital Affiliated to Fujian Medical University

wdgmdyy813@163.com+86 137 0693 0791

Outcome results

None listed

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