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Comparative Study Between Dexmedetomidine & Neostigmine as an Adjuvant to Local Anesthetic Mixture in Peribulbar Block in Vitreoretinal Surgeries

Comparative Study Between Dexmedetomidine & Neostigmine as an Adjuvant to Local Anesthetic Mixture in Peribulbar Block in Vitreoretinal Surgeries

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06501352
Enrollment
81
Registered
2024-07-15
Start date
2023-01-20
Completion date
2024-03-30
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthesia, Vitreoretinal Surgeries

Keywords

Dexmeditomedine, Neostagmine, Peribulbar block

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 .

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 0.5 mg) Group III : ( 4 ml of bupivacaine + 3 ml of mixture of Lidocaine & Hyaluronidase +1ml Normal Saline 0.9%)

Interventions

DRUGDexmedetomidine

Additive to Local anesthetic mixture

DRUGNeostigmine

Additive to Local anesthetic mixture

DRUGSaline

Control

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged from 21 to 60 years. * Patients ASA I to II . * Patient with axial globe length below 26 mm. * Patients consented with Local anesthesia.

Exclusion criteria

* Patient refusal. * Patients below or above the age. * Patients with bleeding disorders. * Patient with axial globe length more than 26 mm. * history of relevant drug allergy to any of the used drugs

Design outcomes

Primary

MeasureTime frameDescription
Onset & Duration of sensory and motor block12 hoursBy minutes , Refers to the time from injection till patient will feel nothing in his eyes , then the time when he regain feeling again

Secondary

MeasureTime frameDescription
Systolic & Diastolic Arterial Blood Pressure12 hoursmeasuring it pre-operative , intra-operative & post-operative
Heart rate12 hoursmeasuring HR per minute pre & intra & post operative
Patient & Surgeon satisfaction12 hoursNo 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 .

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026