ANI and Remifentanil in Skull Pin Fixation.

Phase 4

Completed

• Conditions: Pain, Procedural
• Interventions: Drug: Remifentanil

• Registration Number: NCT05125328
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-11-07
• Study First Posted: 2021-11-18
• Study Start: 2023-04-19
• Primary Completion: 2023-06-13
• Study Completion: 2023-06-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neurosurgery with fixation	Remifentanil	-

Primary Outcome Measures

Name	Time	Method
50% effect concentration of remifentanil	peri-fixation period	50% effect concentration of remifentanil will be recorded at 2 mins before fixation, during fixation, 5mins after fixation, and 15 mins after fixation.
90% effect concentration of remifentanil	peri-fixation period	90% effect concentration of remifentanil will be recorded at 2 mins before fixation, during fixation, 5mins after fixation, and 15 mins after fixation.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan