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Determination of 90% effective concentration of remifentanil with ciprofol and propofol to inhibit tracheal intubation response based on biased coin design

Determination of 90% effective concentration of remifentanil with ciprofol and propofol to inhibit tracheal intubation response based on biased coin design

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078275
Enrollment
Unknown
Registered
2023-12-03
Start date
2023-12-03
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

surgery

Interventions

one:The binary endpoint evaluation and dose allocation principles based on biased coin design,adjusting the target effect site concentration (Ce) of remifentanil with ciprofol
two:The binary endpoint evaluation and dose allocation principles based on k-in-a-row design,adjusting the target effect site concentration (Ce) of remifentanil
three:The binary endpoint evaluation and dose allocation principles based on biased coin design,adjusting the target effect site concentration (Ce) of remifentanil with propofol
four:The binary endpoint evaluation and dose allocation principles based on k-in-a-row design,adjusting the target effect site concentration (Ce) of remifentanil with propofol

Sponsors

The Affiliated Heping Hospital of Changzhi Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Surgical operations; 2. Age 18-65 years old; 3. The American anesthesiologist association (ASA) is graded I-II; 4. Body mass index (body mass index, BMI) 18 ~ 28kg/m2.

Exclusion criteria

Exclusion criteria: 1.Allergies or contraindications to opioids, ciprofol,propofol and their components; 2. Use of other sedatives such as ciprofol or propofol or midazolam within 24 hours before surgery; 3.Patients with severe central nervous system, respiratory or circulatory system diseases; respiratory diseases,difficult airway,Liver dysfunction,renal dysfunction,mental disorders , long-term use of psychotropic drugs, and cognitive dysfunction,long-term use of psychotropic or sedative-hypnotic drugs,drug abuse and drinking; 4.Patients with Allen test positive,Hypertension, Hemodynamic instability (systolic blood pressure [SBP] 180 mmHg, diastolic blood pressure DBP > 110 mmHg, peripheral blood oxygen saturation [SpO2] < 90%); 5.Participation in other clinical studies within recent one month.

Design outcomes

Primary

MeasureTime frame
The 90% effective concentration of remifentanil to inhibit tracheal intubation response for adult surgical patients(EC90);

Secondary

MeasureTime frame
Anesthesia depth index (AI);Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) score ;Systolic blood pressure, mean arterial pressure, and heart rate;

Countries

China

Contacts

Public ContactJiaNing Guo

The Affiliated Heping Hospital of Changzhi Medical College

gjn7520526@icloud.com+86 155 1363 1541

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026