Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414395
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-09
Brief Title:
The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures A Randomized Control Study
Sponsor:
Theodor Bilharz Research Institute
Organization:
Theodor Bilharz Research Institute
Study Overview
Official Title:
The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures A Randomized Control Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Propofol is currently the most common drug used but has drawbacks like narrow therapeutic window and potential complications
Dexmedetomidine is an attractive alternative due to its unique properties like minimal respiratory depression
Studies are ongoing to find the optimal use of dexmedetomidine for these procedures A combination of propofol and dexmedetomidine might be ideal but the best balance between the two drugs needs further investigation
Dexmedetomidine is an attractive alternative due to its unique properties like minimal respiratory depression
Studies are ongoing to find the optimal use of dexmedetomidine for these procedures A combination of propofol and dexmedetomidine might be ideal but the best balance between the two drugs needs further investigation
Detailed Description:
Advanced upper gastrointestinal tract procedures such as Endoscopic retrograde cholangiopancreatography ERCP Endoscopic ultrasound EUS are very important diagnostic and therapeutic procedures for the diagnosis management of many pancreatobiliary pathologies whether benign or malignant 1-4 These procedures require moderate-deep sedation with the patient lying in the lateral or semi-prone position to provide the operator easier access insertion while permitting fluoroscopic visualisation 1-4
Propofol sedation is currently the most popular drug used for advanced endoscopic procedures because of its shorter half-life which results in a shorter recovery time than conventional sedation benzodiazepine or opioid 5 Propofol was administered initially by intermittent boluses but later on was superseded by continuous infusion guided by clinical scoring eg Ramsey sedation score 6 by target-controlled infusion TCI 7 or more recently by bispectral index BIS monitoring 8
Propofol however has a narrow therapeutic window that may cause fluctuation of the level of sedation from moderately deep sedation to near general anesthesia Not only that but also propofol sedation is associated with many other complications including apnoea airway obstruction desaturation hypotension bradycardia gagging restlessness regurgitation vomiting delayed recovery 9
Dexmedetomidine a highly specific potent and selective α2-adrenoceptor agonist was originally introduced as a sedative for critically ill mechanically ventilated patients 9 In addition to sedation it has a group of unique properties in the form of analgesia reduction of sympathetic tone and attenuation of the neuroendocrine and hemodynamic responses to anesthesia and surgery with minimal respiratory depression making it an attractive agent for perioperative sedation especially in remote areas outside the operating theatres 610
The quest to replace propofol coupled with the unique sedo-analgesic properties of dexmedetomidine resulted in the interest in the use of dexmedetomidine for providing sedation for advanced endoscopic procedure 610
In 2021 Srivastava et al 6 studied the effects dexmedetomidine as a sole sedative agent in the form of a loading dose of 1 µgkg-1 followed by 05 µgkg-1hr-1 continuous infusion They reported that although this dexmedetomidine regimen produced adequate sedation in many patients yet it was associated with a relatively high sedation failure rate requiring rescue propofol boluses 6 Moreover dexmedetomidine was associated with bradycardia hypotension 6711
It was 2013 When Wang et al 12 examined the propofol sparing effect of various dexmedetomidine loading doses ranging between 025 1 µgkg-1 followed by a fixed infusion of 05 µgkg-1hr-1 and reported a dose dependent reduction of propofol requirements for induction of sedation 12 However they did not investigate the impact of these dexmedetomidine doses on the total propofol consumption for the whole procedure the incidence of adverse events or the recovery profile of such a combination in the context of sedation for advanced endoscopic procedures Thus the sweet spot 13 where there is a maximal synergism between propofol and dexmedetomidine is still to be identified
Propofol sedation is currently the most popular drug used for advanced endoscopic procedures because of its shorter half-life which results in a shorter recovery time than conventional sedation benzodiazepine or opioid 5 Propofol was administered initially by intermittent boluses but later on was superseded by continuous infusion guided by clinical scoring eg Ramsey sedation score 6 by target-controlled infusion TCI 7 or more recently by bispectral index BIS monitoring 8
Propofol however has a narrow therapeutic window that may cause fluctuation of the level of sedation from moderately deep sedation to near general anesthesia Not only that but also propofol sedation is associated with many other complications including apnoea airway obstruction desaturation hypotension bradycardia gagging restlessness regurgitation vomiting delayed recovery 9
Dexmedetomidine a highly specific potent and selective α2-adrenoceptor agonist was originally introduced as a sedative for critically ill mechanically ventilated patients 9 In addition to sedation it has a group of unique properties in the form of analgesia reduction of sympathetic tone and attenuation of the neuroendocrine and hemodynamic responses to anesthesia and surgery with minimal respiratory depression making it an attractive agent for perioperative sedation especially in remote areas outside the operating theatres 610
The quest to replace propofol coupled with the unique sedo-analgesic properties of dexmedetomidine resulted in the interest in the use of dexmedetomidine for providing sedation for advanced endoscopic procedure 610
In 2021 Srivastava et al 6 studied the effects dexmedetomidine as a sole sedative agent in the form of a loading dose of 1 µgkg-1 followed by 05 µgkg-1hr-1 continuous infusion They reported that although this dexmedetomidine regimen produced adequate sedation in many patients yet it was associated with a relatively high sedation failure rate requiring rescue propofol boluses 6 Moreover dexmedetomidine was associated with bradycardia hypotension 6711
It was 2013 When Wang et al 12 examined the propofol sparing effect of various dexmedetomidine loading doses ranging between 025 1 µgkg-1 followed by a fixed infusion of 05 µgkg-1hr-1 and reported a dose dependent reduction of propofol requirements for induction of sedation 12 However they did not investigate the impact of these dexmedetomidine doses on the total propofol consumption for the whole procedure the incidence of adverse events or the recovery profile of such a combination in the context of sedation for advanced endoscopic procedures Thus the sweet spot 13 where there is a maximal synergism between propofol and dexmedetomidine is still to be identified
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None