SPI and Remifentanil in Skull Pin Fixation

NCT06331663 | Unknown Phase 4

• 1 other identifier: KMUHIRB-F(II)-20240055
• 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 5.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. Inadequate antinociception (Surgical Pleth Index(SPI) \> 80 and hyperdynamics (the increased heart rate (HR) and mean blood pressure (MBP) above 20% of baseline or HR\>100bpm and arterial blood pressure(ABP)\>180/100mmHg)) is defined as failure, therefore we increase remifentanil by 0.5 ng/ml; otherwise, the setting is considered successful without abovementioned situations. Data collection: heart rate, mean blood pressure, Surgical Pleth Index, bispectral Index, pulse pressure variance, systolic pressure variance, 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, surgical pleth 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, 5 mins 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, 5 mins after fixation, and 15 mins after fixation.

  peri-fixation period

Study Arms (1)

Arms

EXPERIMENTAL

Neurosurgery with fixation

Drug: Remifentanil

Interventions

Remifentanil DRUG

first start with remifentanil 5.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. Inadequate antinociception (Surgical Pleth Index(SPI) \> 80 and hyperdynamics (the increased heart rate (HR) and mean blood pressure (MBP) above 20% of baseline or HR\>100bpm and arterial blood pressure(ABP)\>180/100mmHg)) is defined as failure, therefore we increase remifentanil by 0.5 ng/ml; otherwise, the setting is considered successful without abovementioned situations.

Arms

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: March 19, 2024
• First Posted: March 26, 2024
• Study Start: April 1, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-01

Locations

TW (1)