ANI and Remifentanil in Skull Pin Fixation.

Pain, Procedural Clinical Trial

Official title:

To Explore the Optimal Dose of Remifentanil for Skull Pin Fixation in Intracranial Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05125328
• Other study ID #: KMUHIRB-F(I)-20210156
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Pain, Procedural

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