Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501352
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2023-01-10
Brief Title:
Comparative Study Between Dexmedetomidine Neostigmine as an Adjuvant to Local Anesthetic Mixture in Peribulbar Block in Vitreoretinal Surgeries
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Comparative Study Between Dexmedetomidine Neostigmine as an Adjuvant to Local Anesthetic Mixture in Peribulbar Block in Vitreoretinal Surgeries
Status:
COMPLETED
Status Verified Date:
2024-07
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 majority of patients undergoing ophthalmic surgeries are elderly with multiple chronic diseases with increased risk of morbidity and mortality under general anesthesia
Peribulbar anesthesia is widely practiced now as a first-choice local block for ophthalmic surgeries
Dexmedetomidine is a highly selective alpha-2 adrenoceptor It increases central and peripheral nerve blockade and when added to local anesthetic as an adjuvant it will provide better anesthetic quality as well as prolongation of postoperative analgesia
Neostigmine is a parasympathomimetic drug that increase the level of acetylecholine at peripheral muscarinic receptors present in the peripheral nerve endings
Many researches examined the analgesic effects of peripherally administered neostigmine as in intravenous regional anesthesia reporting that addition of neostigmine to the local anesthetic solution accelerated the onset of anesthesia
prolong duration
Peribulbar anesthesia is widely practiced now as a first-choice local block for ophthalmic surgeries
Dexmedetomidine is a highly selective alpha-2 adrenoceptor It increases central and peripheral nerve blockade and when added to local anesthetic as an adjuvant it will provide better anesthetic quality as well as prolongation of postoperative analgesia
Neostigmine is a parasympathomimetic drug that increase the level of acetylecholine at peripheral muscarinic receptors present in the peripheral nerve endings
Many researches examined the analgesic effects of peripherally administered neostigmine as in intravenous regional anesthesia reporting that addition of neostigmine to the local anesthetic solution accelerated the onset of anesthesia
prolong duration
Detailed Description:
81 participants divided into three groups 27 patient in each group with inclusion criteria
Patients aged from 21 to 60 years
Patients ASA I to II undergoing Vitreoretinal Surgeries
Patient with axial globe length below 26 mm
Patients consented with Local anesthesia
The three groups
group I will receive Peribulbar anesthesia block via 25G needle is inserted transcutaneously through the inferotemporal approach at the junction between the medial two third and the lateral third of the lower orbital margin in such a way the bevel is facing the globe and the tip towards the floor of the orbit until the needle passes through the orbital septum it is directed then posteriorly tangential to the floor of the orbit for 25mm length at which the 8 ml local anesthetic mixture is injected 4 ml of bupivacaine 3 ml of mixture of Lidocaine Hyaluronidase 1ml of Dexmedetomidine equivalent to 25 mcg
Ocular compression is applied for 5 minutes by Honan intraocular pressure IOP reducer adjusted at 20mmHg
Group II
Will recieve 4 ml of bupivacaine 3 ml of mixture of Lidocaine Hyaluronidase 1ml of Neostigmine equivalent to 05 mg
Group III
4 ml of bupivacaine 3 ml of mixture of Lidocaine Hyaluronidase 1ml Normal Saline 09
Patients aged from 21 to 60 years
Patients ASA I to II undergoing Vitreoretinal Surgeries
Patient with axial globe length below 26 mm
Patients consented with Local anesthesia
The three groups
group I will receive Peribulbar anesthesia block via 25G needle is inserted transcutaneously through the inferotemporal approach at the junction between the medial two third and the lateral third of the lower orbital margin in such a way the bevel is facing the globe and the tip towards the floor of the orbit until the needle passes through the orbital septum it is directed then posteriorly tangential to the floor of the orbit for 25mm length at which the 8 ml local anesthetic mixture is injected 4 ml of bupivacaine 3 ml of mixture of Lidocaine Hyaluronidase 1ml of Dexmedetomidine equivalent to 25 mcg
Ocular compression is applied for 5 minutes by Honan intraocular pressure IOP reducer adjusted at 20mmHg
Group II
Will recieve 4 ml of bupivacaine 3 ml of mixture of Lidocaine Hyaluronidase 1ml of Neostigmine equivalent to 05 mg
Group III
4 ml of bupivacaine 3 ml of mixture of Lidocaine Hyaluronidase 1ml Normal Saline 09
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