SPI and Remifentanil in Skull Pin Fixation

March 19, 2024 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

To Explore the Optimal Dose of Remifentanil for Skull Pin Fixation Under Surgical Pleth Index Monitor in Intracranial Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arms
Neurosurgery with fixation
Drug: Remifentanil
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
50% effect concentration of remifentanil
Time Frame: peri-fixation period
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
Time Frame: peri-fixation period
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

June 20, 2024

Study Completion (Estimated)

June 20, 2024

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-F(II)-20240055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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