Ignite Creation Date:
2025-12-18 @ 8:12 AM
Ignite Modification Date:
2025-12-23 @ 10:47 PM
Study NCT ID:
NCT04965324
Status:
None
Last Update Posted:
2021-07-23 00:00:00
First Post:
2021-07-07 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Depth of Anaesthesia and Long-term Survival: The Balanced Anaesthesia Follow-up Study
Sponsor:
None
Organization:
Study Overview
Official Title:
Depth of Anaesthesia and Long-term Survival in Elderly Surgical Patients: The Balanced Anaesthesia Study Long-term Follow-up Study
Status:
None
Status Verified Date:
2021-07
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:
BALANCEDLT
Brief Summary:
Anaesthetic depth and complications after major surgery: an international, randomised controlled trial - The BALANCED trial.
In this large, international, randomised controlled trial that enrolled patients aged 60 years and over with significant comorbidity and at increased risk of complications after major surgery, we found no evidence that light general anaesthesia (bispectral index 50) was superior to deep general anaesthesia (bispectral index 35) in reducing 1-year mortality. The BALANCED long term follow up study will look at whether depth of anesthesia affects long term (beyond 1 year) survival.
The primary hypothesis is that targetting BIS 50 will result in superior long term survival compared to targetting BIS 35.
The two secondary hypotheses are that BIS titration to BIS 50 will
1. reduce local cancer recurrence or metastatic spread and consequently improve long-term survival
2. reduce postoperative delirium and associated cognitive impairment and consequently improve long-term survival
Both these mechanisms would be expected to take longer to manifest as reduced survival than 1-year all-cause mortality primary outcome in the Balanced trial. Trials of cancer outcomes often use 5-year survival or similar timeframes to determine evidence of clinical benefit. A steeper cognitive trajectory due to intermediate outcomes such as delirium and cognitive impairment may take longer than 1 year to produce a clinically important difference in survival 30. The 10.6% relative risk reduction seen in the Balanced trial could translate to a statistically and clinically meaningful survival difference in this high-risk population. This population may have 5-year survival of \~80% translating to an absolute survival difference of \~2% potentially (if the \~10% RRR is maintained beyond 1 year). The alternative is that there is no long-term mortality difference which would provide continuing clinical guidance of the safety of current practice in patients who are not at high risk of delirium. This study could provide a rationale for trials in larger populations (such as the total Balanced trial population) or targeted subgroups such as cancer and delirium to provide further mechanistic insights.
Long-term survival is an important patient-centred outcome. The mechanisms described above may manifest in longer-term outcomes providing a clear rationale for the current trial.
In this large, international, randomised controlled trial that enrolled patients aged 60 years and over with significant comorbidity and at increased risk of complications after major surgery, we found no evidence that light general anaesthesia (bispectral index 50) was superior to deep general anaesthesia (bispectral index 35) in reducing 1-year mortality. The BALANCED long term follow up study will look at whether depth of anesthesia affects long term (beyond 1 year) survival.
The primary hypothesis is that targetting BIS 50 will result in superior long term survival compared to targetting BIS 35.
The two secondary hypotheses are that BIS titration to BIS 50 will
1. reduce local cancer recurrence or metastatic spread and consequently improve long-term survival
2. reduce postoperative delirium and associated cognitive impairment and consequently improve long-term survival
Both these mechanisms would be expected to take longer to manifest as reduced survival than 1-year all-cause mortality primary outcome in the Balanced trial. Trials of cancer outcomes often use 5-year survival or similar timeframes to determine evidence of clinical benefit. A steeper cognitive trajectory due to intermediate outcomes such as delirium and cognitive impairment may take longer than 1 year to produce a clinically important difference in survival 30. The 10.6% relative risk reduction seen in the Balanced trial could translate to a statistically and clinically meaningful survival difference in this high-risk population. This population may have 5-year survival of \~80% translating to an absolute survival difference of \~2% potentially (if the \~10% RRR is maintained beyond 1 year). The alternative is that there is no long-term mortality difference which would provide continuing clinical guidance of the safety of current practice in patients who are not at high risk of delirium. This study could provide a rationale for trials in larger populations (such as the total Balanced trial population) or targeted subgroups such as cancer and delirium to provide further mechanistic insights.
Long-term survival is an important patient-centred outcome. The mechanisms described above may manifest in longer-term outcomes providing a clear rationale for the current trial.
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?: