Ain Shams University Hospitals
Cairo, Egypt
NCT Number: NCT06501352
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 .
Looking for future studies?
Notify Me21 year–60 year
All sexes
Interventional
Early Phase 1
Cairo, Egypt
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%)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additive to Local anesthetic mixture
Other names: Marcaine, Xylocaine, Hyaluronidase
Additive to Local anesthetic mixture
Other names: Marcaine, Xylocaine, Hyaluronidase
Control
Other names: Marcaine, Xylocaine, Hyaluronidase
Time frame: 12 hours
By minutes , Refers to the time from injection till patient will feel nothing in his eyes , then the time when he regain feeling again
Time frame: 12 hours
measuring it pre-operative , intra-operative & post-operative
Time frame: 12 hours
measuring HR per minute pre & intra & post operative
Time frame: 12 hours
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 .
Ain Shams University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03413371
Nausea, Neurologic Manifestations
Sosnowiec, Silesian Voivodeship, Poland
View Trial DetailsNCT03389243
Nausea, Neurologic Manifestations
Sosnowiec, Silesian Voivodeship, Poland
View Trial DetailsNCT02973581
Nausea, Neurologic Manifestations
Sosnowiec, Silesian Voivodeship, Poland
View Trial DetailsNCT07585812
Dental Anxiety, Dental Pain
Rize, Rize Province, Turkey (Türkiye)
View Trial Details