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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05125328
Other study ID # KMUHIRB-F(I)-20210156
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 19, 2023
Est. completion date June 13, 2023

Study information

Verified date March 2024
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. According to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by electroencephalography, maintaining a value of 40-60), first start with remifentanil 6.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. An Analgesia Nociception Index(ANI) lower than 30 and hyperdynamics (the increased heart rate(HR) and mean blood pressure(MBP) up 20% of baseline or HR>100bpm and arterial blood pressure(ABP)>180/100mmHg) indicates insufficient analgesia, therefore increase it by 0.5 ng/ml; an ANI higher than 30 and stable hemodynamics (the changes of HR and MBP within 20% of baseline or HR<50bpm and ABP<90/50mmHg) indicates that analgesia is acceptable, and the next patient will decrease it by 0.5 ng/ml during skull pin fixation. Data collection: Heart Rate, Measure blood pressure, Analgesia Nociception Index, Bispectral index, concentrations of propofol and remifentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date June 13, 2023
Est. primary completion date June 13, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: 1. Must be at least 20 years old and less than 80 years old 2. With anesthesia risk grade below grade three (including grade three) (ASA I~III) 3. Patients who are expected to undergo intracranial surgery for skull pin fixation Exclusion Criteria: 1. Those with anesthesia risk classification ASA class IV or higher 2. Those who are allergic to opioid analgesics or propofol drugs 3. Emergency patients

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remifentanil
First start with remifentanil 6.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. An ANI lower than 30 and hyperdynamics (the increased heart rate and mean blood pressure up 20% of baseline or heart rate>100bpm and arterial blood pressure>180/100mmHg) indicates insufficient analgesia, therefore increase it by 0.5 ng/ml; an ANI higher than 30 and stable hemodynamics (the changes of HR and MBP within 20% of baseline or HR<50bpm and ABP<90/50mmHg) indicates that analgesia is acceptable, and the next patient will decrease it by 0.5 ng/ml during skull pin fixation.

Locations

Country Name City State
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 50% effect concentration of remifentanil 50% effect concentration of remifentanil will be recorded at 2 mins before fixation, during fixation, 5mins after fixation, and 15 mins after fixation. peri-fixation period
Primary 90% effect concentration of remifentanil 90% effect concentration of remifentanil will be recorded at 2 mins before fixation, during fixation, 5mins after fixation, and 15 mins after fixation. peri-fixation period
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