A Phase 4 interventional study of Alfentanil in Procedural Pain, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Phase 4, Interventional, and Prevention
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.
242 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 40 is below the median of 83 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 288 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
Neurosurgery with fixation
Drug: Alfentanil
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.
50% effect concentration of alfentanil
50% effect concentration of alfentanil will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.
Time frame: peri-fixation period
95% effect concentration of alfentanil
95% effect concentration of alfentanil will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.
Time frame: peri-fixation period
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2024; primary completion for Dec 2024, 4 months later.
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This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alfentanil
Kaohsiung Medical University Chung-Ho Memorial Hospital →