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Accuracy and Safety of Target-Controlled Infusion of Propofol in Spinal Surgery: A Prospective Randomized Controlled Study

Accuracy and Safety of Target-Controlled Infusion of Propofol in Spinal Surgery: A Prospective Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113303
Enrollment
Unknown
Registered
2025-11-27
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Spinal deformity, Degenerative spinal disease

Interventions

Low-concentration Ciprofol Group:During anesthesia induction, the target-controlled infusion (TCI) pump was set to an initial ciprofol effect-site concentration (Ce) of 0.9 µg/mL. After loss of consci
High-concentration Ciprofol Group:During anesthesia induction, the initial ciprofol effect-site concentration (Ce) was set at 1.2 µg/mL. For maintenance, the Ce recorded at loss of consciousness plus
Propofol Control Group:During anesthesia induction, the initial propofol effect-site concentration (Ce) was set at 4 µg/mL using the Schnider model. For maintenance, the Ce recorded at loss of conscio

Sponsors

The Third Affiliated Hospital of Sun Yet-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective spinal surgery; 2. Aged between 18 and 65 years; 3. Classified as ASA physical status I–III; 4. Undergoing general anesthesia with endotracheal intubation, with an expected surgery duration >180 minutes; 5. Intraoperative neurophysiological monitoring required.

Exclusion criteria

Exclusion criteria: 1. BMI 35 kg/m²; 2. Patients assessed to have a difficult airway; 3. Patients with preoperative motor weakness in the upper or lower limbs; 4. Known allergy to any study drug; 5. Critically ill status (NYHA functional class > III or LVEF = IV; or expected survival < 24 hours); 6. Acute alcohol intoxication, seizure disorders, or severe psychiatric illness; 7. Acute angle-closure glaucoma; 8. Emergency surgery or repeated surgery within a short interval.

Design outcomes

Primary

MeasureTime frame
Effect-site concentration (Ce) of the target-controlled drug;Bispectral Index;

Countries

China

Contacts

Public ContactGuoliang Sun

The Third Affiliated Hospital of Sun Yet-sen University

13632436003@163.com+86 136 3243 6003

Outcome results

None listed

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