Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256354
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-02-05
Brief Title:
Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival in Older Patients Having Major Cancer Surgery A Multicenter Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Intraoperative hypothermia is common in patients having major surgery and the compliance with intraoperative temperature monitoring and management remains poor Studies suggest that intraoperative hypothermia is an important risk factor of postoperative delirium which is associated with worse early and long-term outcomes Furthermore perioperative hypothermia increases stress responses and provokes immune suppression which might promote cancer recurrence and metastasis In a recent trial targeted temperature management reduced intraoperative hypothermia and emergence delirium There was also a trend of reduced postoperative delirium although not statistically significant This trial is designed to test the hypothesis that intraoperative targeted temperature management may reduce postoperative delirium and improves progression-free survival in older patients recovering from major cancer surgery
Detailed Description:
Perioperative hypothermia results from anesthetic-impaired thermoregulatory responses combined with cool operating rooms and exposed body cavities Core temperatures 355C increases perioperative blood loss delays post anesthetic recovery and increases surgical wound infections
Despite guideline recommendations compliance with intraoperative temperature monitoring and management remains poor In a national survey published in 2017 intraoperative hypothermia core temperature 360C occurred in 44 of patients having elective surgery with general anesthesia According to a survey of anesthesiologists in six Asia-Pacific countries Singapore Malaysia Philippines Thailand India and South Korea only 67 of respondents measured temperature intraoperatively during general anesthesia and only 44 report intraoperative active warming and warming was ineffective in more than half of their patients Perioperative hypothermia thus remains common
The 5056-patient PROTECT trial showed that myocardial injury surgical site infections and blood loss were similar in patients randomized to intraoperative core temperatures of 355 or 37C However there are other important complications that may be caused by intraoperative hypothermia including delirium cancer recurrence shivering and thermal discomfort
Perioperative neurocognitive disorders NCDs especially postoperative delirium and postoperative cognitive dysfunction POCD are significant challenges to older patients scheduled for surgery Delirium is a syndrome of acutely occurring and fluctuating changes in attention level of consciousness and cognitive function Postoperative cognitive dysfunction refers to cognitive decline including the ability of study memory action and judgement detected from 30 days to 12 months after surgery
In patients aged 60 years or above the incidence of postoperative delirium is about 12-24 The incidence of POCD is about 7-12 at 3-month follow-up and is associated with delirium although the relationship is probably not causal Delirium and POCD are associated with worse perioperative outcomes including prolonged hospitalization increased complications and high mortality and worse long-term outcomes including shortened overall survival as well as increased dementia and lowered life quality
Postoperative delirium and POCD are multifactorial Predisposing factors include advanced age lower educational level cognitive impairment comorbidities eg cerebrovascular disease diabetes and kidney disease alcohol abuse and malnutrition Precipitating factors include deep anesthesia opioid use benzodiazepines intraoperative blood lossblood transfusion and severe pain Hypothermia may also increase the risk of delirium
Hypothermia provokes both autonomic and behavioral protective responses The first autonomic response is arterio-venous shunt constriction Thermoregulatory vasoconstriction occurs many times a day in a typical hospital environment It is highly effective but does not usually disturb people and is generally considered to be of little consequence Shivering is the other primary autonomic thermoregulatory defense against cold and has a triggering threshold about 1C below the core temperature that triggers vasoconstriction Unlike vasoconstriction shivering is uncomfortable for patients Furthermore it is accompanied by a tripling of catecholamine concentrations hypertension and tachycardia Behavioral thermoregulatory defenses are mediated by thermal comfort and provoke voluntary defensive measures such as putting on a sweater open windows etc Behavioral defenses include air conditioning and building shelters and are thus far stronger than autonomic responses Thermal comfort matters to patients and is thus worth evaluating
Despite advances in surgery and oncology postoperative survival decreases about 10 per year mainly due to cancer recurrence The development of cancer recurrence mainly depends on the balance between the invasive ability of residual cancer cells and the anti-cancer immune function Perioperative hypothermia increases stress responses and provokes immune suppression
The investigators therefore propose to determine whether intraoperative targeted temperature management decreases the incidence of delirium improves thermal comfort reduces postoperative shivering and improves long-term survival in older patients recovering from major cancer surgery Specifically the investigators will test the primary short-term hypothesis that perioperative normothermia core temperature near 368C reduces delirium over the initial 4 postoperative days Secondary short-term hypotheses are that perioperative normothermia improves thermal comfort reduces shivering and reduces delayed neurocognitive recovery The primary long-term hypothesis is that perioperative normothermia improves progression-free survival
Despite guideline recommendations compliance with intraoperative temperature monitoring and management remains poor In a national survey published in 2017 intraoperative hypothermia core temperature 360C occurred in 44 of patients having elective surgery with general anesthesia According to a survey of anesthesiologists in six Asia-Pacific countries Singapore Malaysia Philippines Thailand India and South Korea only 67 of respondents measured temperature intraoperatively during general anesthesia and only 44 report intraoperative active warming and warming was ineffective in more than half of their patients Perioperative hypothermia thus remains common
The 5056-patient PROTECT trial showed that myocardial injury surgical site infections and blood loss were similar in patients randomized to intraoperative core temperatures of 355 or 37C However there are other important complications that may be caused by intraoperative hypothermia including delirium cancer recurrence shivering and thermal discomfort
Perioperative neurocognitive disorders NCDs especially postoperative delirium and postoperative cognitive dysfunction POCD are significant challenges to older patients scheduled for surgery Delirium is a syndrome of acutely occurring and fluctuating changes in attention level of consciousness and cognitive function Postoperative cognitive dysfunction refers to cognitive decline including the ability of study memory action and judgement detected from 30 days to 12 months after surgery
In patients aged 60 years or above the incidence of postoperative delirium is about 12-24 The incidence of POCD is about 7-12 at 3-month follow-up and is associated with delirium although the relationship is probably not causal Delirium and POCD are associated with worse perioperative outcomes including prolonged hospitalization increased complications and high mortality and worse long-term outcomes including shortened overall survival as well as increased dementia and lowered life quality
Postoperative delirium and POCD are multifactorial Predisposing factors include advanced age lower educational level cognitive impairment comorbidities eg cerebrovascular disease diabetes and kidney disease alcohol abuse and malnutrition Precipitating factors include deep anesthesia opioid use benzodiazepines intraoperative blood lossblood transfusion and severe pain Hypothermia may also increase the risk of delirium
Hypothermia provokes both autonomic and behavioral protective responses The first autonomic response is arterio-venous shunt constriction Thermoregulatory vasoconstriction occurs many times a day in a typical hospital environment It is highly effective but does not usually disturb people and is generally considered to be of little consequence Shivering is the other primary autonomic thermoregulatory defense against cold and has a triggering threshold about 1C below the core temperature that triggers vasoconstriction Unlike vasoconstriction shivering is uncomfortable for patients Furthermore it is accompanied by a tripling of catecholamine concentrations hypertension and tachycardia Behavioral thermoregulatory defenses are mediated by thermal comfort and provoke voluntary defensive measures such as putting on a sweater open windows etc Behavioral defenses include air conditioning and building shelters and are thus far stronger than autonomic responses Thermal comfort matters to patients and is thus worth evaluating
Despite advances in surgery and oncology postoperative survival decreases about 10 per year mainly due to cancer recurrence The development of cancer recurrence mainly depends on the balance between the invasive ability of residual cancer cells and the anti-cancer immune function Perioperative hypothermia increases stress responses and provokes immune suppression
The investigators therefore propose to determine whether intraoperative targeted temperature management decreases the incidence of delirium improves thermal comfort reduces postoperative shivering and improves long-term survival in older patients recovering from major cancer surgery Specifically the investigators will test the primary short-term hypothesis that perioperative normothermia core temperature near 368C reduces delirium over the initial 4 postoperative days Secondary short-term hypotheses are that perioperative normothermia improves thermal comfort reduces shivering and reduces delayed neurocognitive recovery The primary long-term hypothesis is that perioperative normothermia improves progression-free survival
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