ANI and Remifentanil in Skull Pin Fixation.

NCT ID: NCT05125328

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-19
• Study Completion Date: 2023-06-13

Brief 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.

Conditions

Pain, Procedural

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

neurosurgery with fixation

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KMUHIRB-F(I)-20210156

Identifier Type: -

Identifier Source: org_study_id