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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 .
81 participants divided into three groups 27 patient in each group with inclusion criteria :
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 0.5 mg)
Group III :
( 4 ml of bupivacaine + 3 ml of mixture of Lidocaine & Hyaluronidase +1ml Normal Saline 0.9%)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmeditomedine group | Active Comparator | Patients in this group will receive Dexmeditomedine in Local anesthesia mixture. |
|
| Neostigmine group | Active Comparator | Patients in this group will receive Neostigmine in Local anesthesia mixture. |
|
| Control group | Placebo Comparator | Patients in this group will receive saline (placebo) in Local anesthesia mixture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Additive to Local anesthetic mixture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Onset & Duration of sensory and motor block | By minutes , Refers to the time from injection till patient will feel nothing in his eyes , then the time when he regain feeling again | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic & Diastolic Arterial Blood Pressure | measuring it pre-operative , intra-operative & post-operative | 12 hours |
| Heart rate | measuring HR per minute pre & intra & post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Egypt |
After completion of work
6 month
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| Neostigmine | Drug | Additive to Local anesthetic mixture |
|
|
| Saline | Drug | Control |
|
|
| 12 hours |
| Patient & Surgeon satisfaction | No pain by VAS score ( from 0 to 10 as 0 no pain & 10 maximum pain ) VAS score intraoperative to assess patient satisfaction & surgeon satisfactory by longer duration of motor & sensory block . | 12 hours |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D002045 | Bupivacaine |
| D008012 | Lidocaine |
| D006821 | Hyaluronoglucosaminidase |
| D009388 | Neostigmine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011133 | Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D009861 | Onium Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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