ANI and Remifentanil in Skull Pin Fixation.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05125328

Collaborator

(none)

Enrollment

Arm

8.7

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Procedural	Drug: Remifentanil	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

To Explore the Optimal Dose of Remifentanil for Skull Pin Fixation in Intracranial Surgery.

Anticipated Study Start Date :

Nov 8, 2021

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: neurosurgery with fixation	Drug: 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.

Arm

Intervention/Treatment

Experimental: neurosurgery with fixation

Drug: 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kaohsiung Medical University Chung-Ho Memorial Hospital

ClinicalTrials.gov Identifier:

NCT05125328

Other Study ID Numbers:

KMUHIRB-F(I)-20210156

First Posted:

Nov 18, 2021

Last Update Posted:

Nov 18, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital

remifentanil

pain

analgesia nociception index

Additional relevant MeSH terms:

Pain, Procedural

Remifentanil

Study Results

No Results Posted as of Nov 18, 2021