Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583811
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Remifentanil and Remimazolam to Limit Patient Movement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Remifentanil and Remimazolam to Limit Patient Movement During Long-Eye Surgeries Under Local Anesthesia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Local anesthetics LA may be administered by injection retrobulbar peribulbar subconjunctival lid or facial block or by instillation topical anesthesia Considerable drawbacks of local anesthesia in these patients include the fact that a few patients can remain comfortable on an operating table for procedures that exceed two or three hours
Sedation may be helpful with LA to decrease the experience of discomfort movement and anxiety which may in turn positively influence hemodynamic parameters patient satisfaction and overall improve surgical safety Sedatives used in eye surgeries include benzodiazepines opioids alpha-adrenoceptor agonists and propofol
Sedation may be helpful with LA to decrease the experience of discomfort movement and anxiety which may in turn positively influence hemodynamic parameters patient satisfaction and overall improve surgical safety Sedatives used in eye surgeries include benzodiazepines opioids alpha-adrenoceptor agonists and propofol
Detailed Description:
Ophthalmic surgery is a precise surgical procedure that requires absolute immobilization Many ophthalmic procedures can be performed safely in an outpatient setting using local anesthesia
Propofol is currently the most commonly used intravenous anesthetic It has a rapid onset of action a short half-life and is associated with rapid recovery of cognitive ability However propofol can lead to injection pain propofol infusion syndrome and hemodynamic and respiratory depression Therefore there is a need for new anesthetic drugs with high efficacy and fewer side effects while providing stable and controllable anesthesia
Remifentanil is a short-acting esterase metabolized opioid with analgesic and sedative effects Its half-life is about 5-10 min so that it can be titrated closely in response to changes in intraoperative requirements and with a low risk of accumulation
Remimazolam is a novel ultrashort-acting benzodiazepine agonist that works on γ-aminobutyric acid type A GABA-A receptors to reduce neuronal excitation and thereby achieve hypoactivity and sedation in the body Remimazolam is metabolized by a nonspecific esterase and the metabolite has no pharmacological effect which allows prolonged infusion without accumulation
It provides rapid anesthesia and arousal while stabilizing hemodynamics and produces less depression of respiration making it more suitable for use in elderly and hemodynamically unstable patients
Propofol is currently the most commonly used intravenous anesthetic It has a rapid onset of action a short half-life and is associated with rapid recovery of cognitive ability However propofol can lead to injection pain propofol infusion syndrome and hemodynamic and respiratory depression Therefore there is a need for new anesthetic drugs with high efficacy and fewer side effects while providing stable and controllable anesthesia
Remifentanil is a short-acting esterase metabolized opioid with analgesic and sedative effects Its half-life is about 5-10 min so that it can be titrated closely in response to changes in intraoperative requirements and with a low risk of accumulation
Remimazolam is a novel ultrashort-acting benzodiazepine agonist that works on γ-aminobutyric acid type A GABA-A receptors to reduce neuronal excitation and thereby achieve hypoactivity and sedation in the body Remimazolam is metabolized by a nonspecific esterase and the metabolite has no pharmacological effect which allows prolonged infusion without accumulation
It provides rapid anesthesia and arousal while stabilizing hemodynamics and produces less depression of respiration making it more suitable for use in elderly and hemodynamically unstable patients
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