Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480539
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-11
Brief Title:
The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients DEXSLEEP Study
Sponsor:
Ziekenhuis Oost-Limburg
Organization:
Ziekenhuis Oost-Limburg
Study Overview
Official Title:
The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients DEXSLEEP Study
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:
DEXSLEEP
Brief Summary:
In the aftermath of major surgery many patients suffer from pain fatigue reduced general well-being and cognitive dysfunction Another common concern after major surgery is sleep impairment and there is little known about its effect on postoperative morbidity especially postoperative fatigue and muscle function
Dexmedetomidine has been shown to possibly improve postoperative sleep quality in critically ill patients However whether the administration of dexmedetomidine translates into reduced postoperative fatigue andor weakness and improved enhanced recovery after surgery by improving sleep is currently unknown
The DEXSLEEP study will evaluate the effect of nocturnal administration of dexmedetomidine as compared to placebo ie no dexmedetomidine on postoperative quality of recovery postoperative fatigue and muscle weakness
Dexmedetomidine has been shown to possibly improve postoperative sleep quality in critically ill patients However whether the administration of dexmedetomidine translates into reduced postoperative fatigue andor weakness and improved enhanced recovery after surgery by improving sleep is currently unknown
The DEXSLEEP study will evaluate the effect of nocturnal administration of dexmedetomidine as compared to placebo ie no dexmedetomidine on postoperative quality of recovery postoperative fatigue and muscle weakness
Detailed Description:
Due to the increase in life expectancy in the developing world the number of elderly patients undergoing major surgery is expected to increase in the coming years These elderly patients even healthy older adults have a reduced physiologic reserve such that organ systems may be compromised during and after surgical stress placing them at greater risk of morbidity and mortality after surgery
A common concern after surgery is sleep impairment Patients often develop significant sleep disturbances after major surgery and particular elderly patients are more prone to develop sleep disturbances when compared to younger patients Sleep plays an essential role in the homeostasis of multiple organ systems and cognitive function A good night sleep is deemed essential for a good functional recovery Taking this into account it seems logical that postoperative sleep disturbances could be a contributing factor to postoperative fatigue which is reported by patients as one of the most distressing symptoms after surgery and is thought to be the chief contributor to delayed recovery after surgery
The endocrinological surgical response probably plays an essential role in postoperative sleep disturbances experienced by surgical patients by causing neuroinflammation Keeping this in mind dexmedetomidine might be an interesting pharmacological intervention since it has the ability to attenuate several factors that contribute to postoperative sleep disturbances including the endocrinological surgical stress response However whether the nocturnal administration of dexmedetomidine translates into improved postoperative sleep quality after elective major surgery subsequently reduced postoperative fatigue and muscle weakness and improved enhanced recovery after surgery by improving sleep is currently unknown
Therefore the main objective of this prospective clinical trial is to evaluate the effect of nocturnal dexmedetomidine on early postoperative outcomes ie quality of recovery in elderly patients 60 years or older undergoing major surgery
A common concern after surgery is sleep impairment Patients often develop significant sleep disturbances after major surgery and particular elderly patients are more prone to develop sleep disturbances when compared to younger patients Sleep plays an essential role in the homeostasis of multiple organ systems and cognitive function A good night sleep is deemed essential for a good functional recovery Taking this into account it seems logical that postoperative sleep disturbances could be a contributing factor to postoperative fatigue which is reported by patients as one of the most distressing symptoms after surgery and is thought to be the chief contributor to delayed recovery after surgery
The endocrinological surgical response probably plays an essential role in postoperative sleep disturbances experienced by surgical patients by causing neuroinflammation Keeping this in mind dexmedetomidine might be an interesting pharmacological intervention since it has the ability to attenuate several factors that contribute to postoperative sleep disturbances including the endocrinological surgical stress response However whether the nocturnal administration of dexmedetomidine translates into improved postoperative sleep quality after elective major surgery subsequently reduced postoperative fatigue and muscle weakness and improved enhanced recovery after surgery by improving sleep is currently unknown
Therefore the main objective of this prospective clinical trial is to evaluate the effect of nocturnal dexmedetomidine on early postoperative outcomes ie quality of recovery in elderly patients 60 years or older undergoing major surgery
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?:
False
Is an FDA AA801 Violation?:
None