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Efficacy and safety of ciprofol as an adjunctive sedative during spinal anesthesia

Efficacy and safety of ciprofol as an adjunctive sedative during spinal anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102635
Enrollment
Unknown
Registered
2025-05-16
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

None

Interventions

Ciprofol Group:A loading dose of 0.1 mg/kg of intravenous bolus injection was injected at a constant rate,followed by a pump of ciprofol at a starting rate of 0.3 mg/kg/h.
Propofol group:A loading dose of propofol injection was given at a constant intravenous bolus rate of 0.5 mg/kg, followed by a pump of propofol at a starting rate of 1.5 mg/kg/h.

Sponsors

Affiliated Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Gender is not limited, age 18>= and = 18 and = 60 and = 90 mmHg and = 60 mmHg and = 92%;

Exclusion criteria

Exclusion criteria: (1) Patients with contraindications to regional anesthesia, such as coagulation dysfunction; (2) Patients with a history of cardiovascular system, respiratory system, nervous system, gastrointestinal tract or a history of alcoholism and drug abuse three months before surgery; (3) Those who are allergic to propofol injection, excipients in cyclopofol injection and various anesthetic drugs; (4) Patients who use any drugs for hypnosis, anesthesia, analgesia, and muscle relaxant before surgery; (5) Patients with mental illness or inability to cooperate; (6) Patients who are judged to be unsuitable for inclusion for other reasons.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
Percentage of time to maintain MOAA/S 3-4 points, MOAA/S 1-2 points, and MOAA/S=5 points to the entire study dosing time;;The time from initiation of intravenous bolus loading dose to the first MOAA/S<4, and the proportion of subjects with MOAA/S<4 within 3 minutes;Proportion of subjects receiving salvage sedation;Patient's vital signs;The number of dose adjustments that occurred;Sedative medication use;The time from stopping the infusion of the investigational drug to reaching MOAA/S=5 points for the first time after surgery;Duration of stay in the recovery room;Recovery when leaving the room;

Countries

China

Contacts

Public ContactChen Mi

Affiliated Hospital of Guizhou Medical University

147459443@qq.com+86 139 8408 3222

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 23, 2026