Last reviewed · How we verify
NCT06563297
To Explore the Optimal Dose of Alfentanil for Skull Pin Fixation in Intracranial Surgery
Phase 4 trial testing Alfentanil in Procedural Pain in 40 participants. Not yet recruiting.
31 December 2024
Quick facts
| Lead sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 40 |
| Start date | 13 August 2024 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Alfentanil (ALFENTANIL) — full drug profile →
Conditions studied
- Procedural Pain — all drugs for Procedural Pain →
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Who can join
Adults 18 to 80, any sex, with Procedural Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06563297
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Alfentanil
Trials testing the same drug.
- NCT06414018 — Effect of Equivalent Dose of Alfentanil and Sufentanil in Bronchoscopic Treatment · NA · completed
- NCT06212622 — Is the Rate of Early Mobilisation in Hip Fracture Patients Using Alfentanil Better Than Standard Opioid Analgesia? · completed
- NCT03359395 — Pre-medication With Alfentanil vs Placebo During ECT · Phase 4 · completed
Other recruiting trials for Procedural Pain
Currently open trials in the same condition.
- NCT07512791 — Effect of Bagua Auriculotherapy on Pain in Patients Undergoing Hysteroscopy · NA · active not recruiting
- NCT07094451 — Virtual Reality for Pain Control in US-Guided Obstetric Needle Procedures · NA · recruiting
- NCT06913270 — Virtual Reality Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care · NA · recruiting
- NCT07440342 — TEAS for Sedation During ERCP: A Multicenter Trial · NA · recruiting
- NCT06346171 — VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain · NA · active not recruiting
Other Kaohsiung Medical University Chung-Ho Memorial Hospital trials
Trials by the same sponsor.
- NCT07342426 — High and Low Dose High-intensity Laser Therapy Lateral Epicondylitis · Phase 4 · recruiting
- NCT07346469 — Exploring the Effects of Magnesium Ions on Peripheral Neuropathy, Serum Magnesium Ion Concentration,Sleep Quality, and Q · NA · not yet recruiting
- NCT07154407 — AI-assisted Masticatory Muscle Training in Patients With Schizophrenia · NA · not yet recruiting
- NCT07154628 — Effect of Topical Lidocaine Spraying on the Vocal Cords Before Intubation During Robotic Surgery: a Randomized Controlle · Phase 4 · not yet recruiting
- NCT07126444 — Effects of an Exercise Snack Intervention on Employee Health and Work Performance · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06563297 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kaohsiung Medical University Chung-Ho Memorial Hospital
- Last refreshed: 20 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06563297.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing