Viewing Study NCT06331663



Ignite Creation Date: 2024-05-06 @ 8:18 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06331663
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-26
First Post: 2024-03-19

Brief Title: SPI and Remifentanil in Skull Pin Fixation
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Overview

Official Title: To Explore the Optimal Dose of Remifentanil for Skull Pin Fixation Under Surgical Pleth Index Monitor in Intracranial Surgery
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
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 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 50-60 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 electroencephalography maintaining a value of 40-60 first start with remifentanil 50 ngml and use the up and down method as adjust 05 ngml of concentration of remifentanil each time Inadequate antinociception Surgical Pleth IndexSPI 80 and hyperdynamics the increased heart rate HR and mean blood pressure MBP above 20 of baseline or HR100bpm and arterial blood pressureABP180100mmHg is defined as failure therefore we increase remifentanil by 05 ngml otherwise the setting is considered successful without abovementioned situations

Data collection heart rate mean blood pressure Surgical Pleth Index bispectral Index pulse pressure variance systolic pressure variance concentrations of propofol and remifentanil 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?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None