ANI and Remifentanil in Skull Pin Fixation.

NCT05125328 | Completed Phase 4

• 1 other identifier: KMUHIRB-F(I)-20210156
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

remifentanil; pain; analgesia nociception index

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

neurosurgery with fixation

EXPERIMENTAL

Drug: Remifentanil

Interventions

Remifentanil 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.

neurosurgery with fixation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 20 years old and less than 80 years old
• With anesthesia risk grade below grade three (including grade three) (ASA I\~III)
• Patients who are expected to undergo intracranial surgery for skull pin fixation

You may not qualify if:

• Those with anesthesia risk classification ASA class IV or higher
• Those who are allergic to opioid analgesics or propofol drugs
• Emergency patients

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Pain, Procedural; Pain

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 18, 2021
• Study Start: April 19, 2023
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

TW (1)