Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563297
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
To Explore the Optimal Dose of Alfentanil for Skull Pin Fixation in Intracranial Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
To Explore the Optimal Dose of Alfentanil for Skull Pin Fixation Under Surgical Pleth Index Monitor in Intracranial Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ngml 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 ngml and use the up and down method as adjust 25 ngml of concentration of alfentanil each time An SPI higher than 80 and hyperdynamics the increased HR and MBP up 20 of baseline or HR100bpm and ABP180100mmHg indicates insufficient analgesia therefore increase it by 25 ngml at the next patient an SPI lower than 80 and stable hemodynamics the changes of HR and MBP within 20 of baseline or HR50bpm and ABP9050mmHg indicates that analgesia is acceptable and the next patient will decrease it by 25 ngml 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 ABP9050 mmHg or bradycardia HR50 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None