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Study on the Median Effective Dose of a Propofol-Alfentanil-Lidocaine Mixture in Inhibiting Body Movement Responses During Ocular Regional Blockade

Study on the Median Effective Dose of a Propofol-Alfentanil-Lidocaine Mixture in Inhibiting Body Movement Responses During Ocular Regional Blockade

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095627
Enrollment
Unknown
Registered
2025-01-09
Start date
2025-01-25
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Body movement response during ocular regional blockade

Interventions

Propofol-alfentanil-lidocaine mixture group:MAC using a Propofol-Alfentanil-Lidocaine mixture

Sponsors

The Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 85 years old; 2.Selective ophthalmic day surgery; 3.Allocated to receive peribulbar/retrobulbar block under monitored anesthesia care(MAC); 4.The American Society of Anesthesiologists (ASA) physical status ?-?; 5.Agreed to sign the informed consent form for the trial;

Exclusion criteria

Exclusion criteria: 1.Uncontrolled malignant hypertension (>=180/110 mmHg); 2.Severe cardiac arrhythmias including sick sinus syndrome, second-degree and third-degree atrioventricular block, double-bundle branch block, and severe bradycardia (heart rate = 3); 8.Morbid obesity (BMI >=30 kg/m²); 9.History of allergy to study drugs; 10.Cognitive impairment precluding the ability to respond to study questionnaires; 11.Hearing impairment;

Design outcomes

Primary

MeasureTime frame
Ramsay score and motor response during ocular block after administration of propofol-alfentanil-lidocaine mixture for 1 minute;ED50;

Secondary

MeasureTime frame
Perioperative adverse events;Intraoperative sedation and analgesia index;Body movement responses;Numeric rating scale pain score;Time from PACU admission to achieving a modified Aldrete score >=9;Iowa Satisfaction with Anesthesia Scale (ISAS);Vital signs;

Countries

China

Contacts

Public ContactWang Yongyi

The Zhongshan Ophthalmic Center, Sun Yat-sen University

wyyshadow@163.com+86 20 66683245

Outcome results

None listed

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