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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06563297
Enrollment
40
Registered
2024-08-20
Start date
2024-08-13
Completion date
2024-12-31
Last updated
2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural Pain

Keywords

alfentanil, pain, surgical pleth index

Brief summary

Forty patients were enrolled, and all patients used total intravenous anesthesia (alfentanil-propofol based TIVA) as anesthesia induction and maintenance. According to our experience, patients who underwent intracranial surgery for skull pin fixation used alfentanil 100 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 EEG, maintaining a value of 40-60), first start with alfentanil 100 ng/ml, and use the up and down method as adjust 25 ng/ml of concentration of alfentanil each time. An SPI higher than 80 and hyperdynamics (the increased HR and MBP up 20% of baseline or HR\>100bpm and ABP\>180/100mmHg) indicates insufficient analgesia, therefore increase it by 25 ng/ml at the next patient; an SPI lower than 80 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 25 ng/ml during skull pin fixation. If the analgesia is inadequate, increase alfentanil concentration will be prescribed. On the other hand, if analgesia is adequate, however hyperdynamics was noted, beta blocker or calcium channel blocker will be prescribed. If hypotension (ABP\<90/50 mmHg) or bradycardia (HR\<50 bpm) occur, we first stop alfentanil infusion and treated with ephedrine or atropine, respectively. Data collection: HR, MBP, SPI, BIS, systolic pressure variation (SPV), pulse pressure variation (PPV) , concentrations of propofol and alfentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed.

Interventions

DRUGAlfentanil

We first start with alfentanil 100 ng/ml, and use the up and down method as adjust 25 ng/ml of concentration of alfentanil each time. An SPI higher than 80 and hyperdynamics (the increased HR and MBP up 20% of baseline or HR\>100bpm and ABP\>180/100mmHg) indicates insufficient analgesia, therefore increase it by 25 ng/ml at the next patient; an SPI lower than 80 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 25 ng/ml during skull pin fixation. If the analgesia is inadequate, increase alfentanil concentration will be prescribed. On the other hand, if analgesia is adequate, however hyperdynamics was noted, beta blocker or calcium channel blocker will be prescribed. If hypotension (ABP\<90/50 mmHg) or bradycardia (HR\<50 bpm) occur, we first stop alfentanil infusion and treated with ephedrine or atropine, respectively.

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Must be at least 18 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 alfentanil or propofol drugs * Emergency patients

Design outcomes

Primary

MeasureTime frameDescription
50% effect concentration of alfentanilperi-fixation period50% effect concentration of alfentanil will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.
95% effect concentration of alfentanilperi-fixation period95% effect concentration of alfentanil will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026