Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03950557
Other study ID # FLUO
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date December 31, 2020

Study information

Verified date May 2019
Source University of Padua
Contact Federico Linassi, MD
Phone 049 8754256
Email federico.linassi@studenti.unipd.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aim of this trial is to define if Post-Operative Cognitive Dysfunction and Delirium, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative neuromonitoring values.


Description:

Post-Operative Cognitive Dysfunction and Emergence Delirium has not been yet investigated after general anaesthesia with Targeted-Controlled-Infusion (TCI), daily used in the investigator's Hospital to anesthetize patients undergoing spinal surgery. Aim of this trial is to define if neurocognitive tests (Pfeiffer test, Montreal Cognitive Assessment, Trail Making Test A and B, Digit Span Test, Confusion Assessment Method) before and after surgery relate to concentrations at effector's site (Ec) of propofol and remifentanil TCI, the values of Bispectral Index, blood pressure values and usage of drugs to increase arterial blood pressure.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion

- Surgical duration > 60 minutes

Exclusion Criteria:

- Neurological pathologies

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Padua Maran Eleonora

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Post-Operative Cognitive Dysfunction in spinal-surgery patients detected with Montreal Cognitive Assessment test Discover incidence of Post-Operative Cognitive decline analyzing changes in Post-Operative Cognitive Dysfunction changes between Pre-operative Montreal Cognitive Assessment test score and post-operative Montreal Cognitive Assessment test score Patients will be subjected to Montreael Cognitive Assessment (MOCA) test one day before surgery and 1 day after surgery. This test has a score ranging from 1 (minimum) to 30 (maximum). Better neurocognitve outcome with higher scores)
Primary Incidence of Post-Operative Cognitive Dysfunction in spinal-surgery patients detected with Trail Making Test A and B Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Trail Making Test A and B test score and post-operative Trail Making Test A and B test score Patients will be subjected to Trail Making Test (TMT) A and B one day before surgery and 1day after surgery. These tests will be evaluated in seconds required to be completed (better neurocognitive outcome with fewer seconds required)
Primary Incidence of Post-Operative Cognitive Dysfunction in spinal-surgery patients detected with Digit Span Test Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Digit Span Test score and post-operative Digit Span Test test score Patients will be subjected to DST one day before surgery and 1 day after surgery. Better neurocognitve outcome with higher scores
Primary Incidence of Emergence Delirium in spinal-surgery patients Discover Emergence Delirium analyzing Post-operative Confusion Assessment Method (CAM) delivered 15 minutes after the awakening of patients Patients will be subjected to CAM 15 minutes after the awakening after general anesthesia
Primary Incidence of Emergence Delirium in spinal-surgery patients Discover Emergence Delirium analyzing Post-operative Confusion Assessment Method (CAM) delivered 60 minutes after the awakening of patients Patients will be subjected to CAM 60 minutes after the awakening after general anesthesia
See also
  Status Clinical Trial Phase
Completed NCT03787849 - Epigenetics in PostOperative Pediatric Emergence Delirium N/A
Completed NCT03788564 - The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation
Recruiting NCT01221025 - Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain Phase 4
Not yet recruiting NCT06035757 - The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery Phase 4
Not yet recruiting NCT04291820 - Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence N/A
Completed NCT05124067 - Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children Phase 1
Recruiting NCT05091242 - The PREVENT AGITATION Trial II - Children ≤1 Year Phase 2/Phase 3
Completed NCT03330236 - EEG - Guided Anesthetic Care and Postoperative Delirium N/A
Completed NCT04531020 - Incidence of Emergence Delirium in the PACU
Completed NCT05105178 - Verbal Stimulation of Orientation on Emergence Agitation N/A
Completed NCT03285243 - Effect of Monochromatic Light on Incidence of Emergence Delirium in Children N/A
Recruiting NCT04621305 - Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia Phase 4
Completed NCT01096797 - Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children Phase 4
Recruiting NCT03330613 - Emergence Delirium and Recovery Time in Children N/A
Completed NCT05872087 - Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries Phase 1
Recruiting NCT06326983 - Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery N/A
Not yet recruiting NCT06387953 - Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy N/A
Not yet recruiting NCT06406257 - Temperature Management on Postoperative Delirium N/A
Not yet recruiting NCT05883280 - The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery N/A
Not yet recruiting NCT05821972 - Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate Phase 4