Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369103
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-08
Brief Title:
The Sedative Effects of Dexmedetomidine VS Propofol During Peribulbar Anesthesia in Patients Undergoing Vitrectomy Surgery
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
Comparison of the Sedative Effects of Dexmedetomidine and Propofol During Peribulbar Anaesthesia in Patients Undergoing Vitrectomy Surgery A Prospective Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The aim of the work to compare the Sedative Effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery on hemodynamic respiratory parameters recovery profile analgesic effects post-operative cognitive function patients satisfaction and adverse events
Detailed Description:
In ocular surgery local anesthesia or regional anesthesia is generally preferred over general anesthesia because of quicker patient rehabilitation and the avoidance of possible complications from general anesthesia However even with these anesthesia techniques pain fear and anxiety are major predictors of lower patient satisfaction
Vitrectomy surgery is one of the most common outpatient ophthalmic surgeries It can be performed with peribulbar anesthesia and intravenous IV sedation support allowing the procedure to be completed in most patients without the need for general anesthesia Vitrectomy surgery is a painful and lengthy procedure therefore sedation is applied to reduce patient agitation ensuring both surgical comfort and hemodynamic stability However various complications can arise during the perioperative period depending on the sedation agent used
Intravenous sedation is frequently used during ophthalmic regional anesthesia There is no ideal drug for sedation or analgesia Various drugs either alone or in combination have been used with different methods of administration The preferred sedative agent for ophthalmic surgeries performed under local anesthesia should have rapid onset but a short duration of action to ensure rapid recovery It should be non-accumulating non-toxic and have a favorable therapeutic index with minimal side effects Unfortunately no drug is presently available that fulfils all these criteria The available sedative drugs are benzodiazepines intravenous anaesthetic induction agents eg propofol opiates and α-adrenoreceptor agonists such as dexmedetomidine or clonidine
Among anesthetic agents Dexmedetomidine is a strong selective α2-adrenergic agonist with sympatholytic anxiolytic analgesic and dose-dependent sedativehypnotic properties without causing respiratory depression
Moreover the use of dexmedetomidine reduces anesthetic and opioid requirements and also psychomotor function to be reserved
Dexmedetomidine is the preferred agent for sedation in retinal surgery because of its ability to maintain hemodynamic and respiratory stability
On the other hand Propofol is an important intravenous anesthetic agent that has been extensively used as a sedative agent for ophthalmic procedures due to its favorable pharmacokinetic properties Propofol has short duration of action no cumulative effect unique recovery profile as well as rapid emergence and anti-emetic properties Respiratory depression and reduced blood pressure are major side effects of propofol However it has been suggested that propofol may still be safely administered if given at a lower dose Other side effects of propofol include pain on injection increased oculocardiac reflex anaphylaxis and patient movement
Despite many benefits propofol sedation has been involved in producing the photic sneezing reflex induced by periocular injections of anesthetics
Unexpected or sudden sneezing during injection can be a dangerous side effect in periocular injection in which abrupt head movement may cause globe injury
Vitrectomy surgery is one of the most common outpatient ophthalmic surgeries It can be performed with peribulbar anesthesia and intravenous IV sedation support allowing the procedure to be completed in most patients without the need for general anesthesia Vitrectomy surgery is a painful and lengthy procedure therefore sedation is applied to reduce patient agitation ensuring both surgical comfort and hemodynamic stability However various complications can arise during the perioperative period depending on the sedation agent used
Intravenous sedation is frequently used during ophthalmic regional anesthesia There is no ideal drug for sedation or analgesia Various drugs either alone or in combination have been used with different methods of administration The preferred sedative agent for ophthalmic surgeries performed under local anesthesia should have rapid onset but a short duration of action to ensure rapid recovery It should be non-accumulating non-toxic and have a favorable therapeutic index with minimal side effects Unfortunately no drug is presently available that fulfils all these criteria The available sedative drugs are benzodiazepines intravenous anaesthetic induction agents eg propofol opiates and α-adrenoreceptor agonists such as dexmedetomidine or clonidine
Among anesthetic agents Dexmedetomidine is a strong selective α2-adrenergic agonist with sympatholytic anxiolytic analgesic and dose-dependent sedativehypnotic properties without causing respiratory depression
Moreover the use of dexmedetomidine reduces anesthetic and opioid requirements and also psychomotor function to be reserved
Dexmedetomidine is the preferred agent for sedation in retinal surgery because of its ability to maintain hemodynamic and respiratory stability
On the other hand Propofol is an important intravenous anesthetic agent that has been extensively used as a sedative agent for ophthalmic procedures due to its favorable pharmacokinetic properties Propofol has short duration of action no cumulative effect unique recovery profile as well as rapid emergence and anti-emetic properties Respiratory depression and reduced blood pressure are major side effects of propofol However it has been suggested that propofol may still be safely administered if given at a lower dose Other side effects of propofol include pain on injection increased oculocardiac reflex anaphylaxis and patient movement
Despite many benefits propofol sedation has been involved in producing the photic sneezing reflex induced by periocular injections of anesthetics
Unexpected or sudden sneezing during injection can be a dangerous side effect in periocular injection in which abrupt head movement may cause globe injury
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