Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165971
Status:
COMPLETED
Last Update Posted:
2007-04-17
First Post:
2005-09-09
Brief Title:
Recovery From General Anesthesia
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Recovery From General Anesthesia
Status:
COMPLETED
Status Verified Date:
2007-04
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:
General anesthesia allows people to have surgery without experiencing the procedure or pain To remain unconscious the depth of sleep must be monitored Various monitors have been developed one of which is BIS short for bispectral index BIS monitors the level of sleep during anesthesia and improves patient recovery because the amount of sleep drugs can be fine-tuned to the individual Patients who need a lot to stay asleep get more and those who need less get less As a result patients tend to wake up faster with BIS monitoring as compared to standard practice not using BIS Little is known about the long-term effects of BIS monitoring This study investigates whether BIS monitoring during anesthesia improves long-term outcome well after surgery is over The hypothesis is that it does Two groups of patients are compared one in which BIS monitoring was used and one in which it was not Groups are compared on tests of memory concentration and mental well-being to see if one does and feels better than the other The investigators also take blood samples to see how well patients bodies deal with the surgery The investigators expect the BIS monitoring group to do better
Detailed Description:
Monitoring the effect of sedative drugs used to anesthetize people during surgery is complex Technological advances that focus on brain activity electroencephalogram EEG recently yielded promising parameters such as the bispectral index BIS BIS is a scale from 100 awake to 0 complete cortical EEG suppression and values between 45 and 60 are recommended for surgical anesthesia Compared to standard practice the use of BIS speeds emergence and early recovery from anesthesia while reducing anesthetic drug use Little is known about the long-term effects of BIS monitoring but it is not unlikely that early improvements in clinical outcome persist over time Studies have associated first-year postoperative mortality to prolonged periods of too deep surgical anesthesia as defined by BIS levels below 45 BIS monitoring could thus serve an important function in enhancing patient management and care Prospective randomized controlled clinical trials of BIS monitoring and its long-term effects are lacking however
The primary goal of this study is to assess whether monitoring of sedation level during general anesthesia using BIS enhances long-term recovery Two outcome domains are of interest Cognitive function attention vigilance and memory and immune system responses inflammation The former is measured using a computerized test battery while blood samples cytokines and TNF-a levels address the latter Patients are randomly assigned to one of two monitoring groups While BIS is recorded in both the values are not available to guide drug dosing in the standard practice group ie blinded In this group parameters such as changes in respiration heart beat and blood pressure guide the amount of drugs being administered In the other group BIS readings are available and used to titrate drugs to values between 50 and 60 target 55 The anesthetic protocol is similar for both Recovery is assessed repeatedly in all patients at various intervals after surgery 6 hrs 1st and 2nd day and 1 month follow-up In this way we intend to capture outcome-variation over time
The primary goal of this study is to assess whether monitoring of sedation level during general anesthesia using BIS enhances long-term recovery Two outcome domains are of interest Cognitive function attention vigilance and memory and immune system responses inflammation The former is measured using a computerized test battery while blood samples cytokines and TNF-a levels address the latter Patients are randomly assigned to one of two monitoring groups While BIS is recorded in both the values are not available to guide drug dosing in the standard practice group ie blinded In this group parameters such as changes in respiration heart beat and blood pressure guide the amount of drugs being administered In the other group BIS readings are available and used to titrate drugs to values between 50 and 60 target 55 The anesthetic protocol is similar for both Recovery is assessed repeatedly in all patients at various intervals after surgery 6 hrs 1st and 2nd day and 1 month follow-up In this way we intend to capture outcome-variation over time
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19907000 | None | None | None |