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Half effective concentration (EC50), half effective dose (ED50), and 95% effective dose (ED95) of remifentanil for tracheal extubation during cochlear implantation in school-age children: a dose discovery study

Half effective concentration (EC50), half effective dose (ED50), and 95% effective dose (ED95) of remifentanil for tracheal extubation during cochlear implantation in school-age children: a dose discovery study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105996
Enrollment
Unknown
Registered
2025-07-15
Start date
2025-07-15
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Cochlear implantation surgery

Interventions

EC50 group:The initial target controlled infusion concentration of remifentanil is 2.0 ng/mL, and according to the sequential method, it is preset to be adjusted in a gradient of 0.2 ng/mL. Based on t
1: mild cough, only once, no agitation
2: moderate cough,>once, but lastingonce, but lasting<5s, with agitation but not affecting extubation
3: Persistent cough for more than 5 seconds, accompanied by head lifting, breath holding, cyanosis, etc. Once the MAP or HR exceeds 20% of the baseline value and/or moderate to severe coughing occurs,

Sponsors

Shandong Second Provincial General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Age 6-12 years old; (2) American Society of Anesthesiologists (ASA) grades I-II; (3) Selective cochlear implantation surgery for pedestrians, with a surgery time of 1-2 hours; (4) Plan to undergo general anesthesia; (5) Sign informed consent forms, conduct pain scoring education, and cooperate in data collection.

Exclusion criteria

Exclusion criteria: (1) The surgery time is greater than 2 hours; (2) Preoperative concomitant congenital cardiovascular disease; (3) Difficult airway assessment; (4) Suffering from severe heart disease; (5)BMI >= 30 kg/m^2; (6) History of chronic pain or opioid use; (7) Any other reasons that prevent cooperation with the study, such as congenital mental illness.

Design outcomes

Primary

MeasureTime frame
Heart rate;Mean arterial pressure;Depth of anesthesia;

Countries

China

Contacts

Public ContactJuan Zhao

Shandong Second Provincial General Hospital

15588837417@163.com+86 155 8883 7417

Outcome results

None listed

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