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NCT Number: NCT06501352

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

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 .

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ain Shams University Hospitals

Cairo, Egypt

About this study

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%)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Additive to Local anesthetic mixture

Other names: Marcaine, Xylocaine, Hyaluronidase

Neostigmine

Drug

Additive to Local anesthetic mixture

Other names: Marcaine, Xylocaine, Hyaluronidase

Saline

Drug

Control

Other names: Marcaine, Xylocaine, Hyaluronidase

Primary outcomes

  1. Onset & Duration of sensory and motor block

    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

Secondary outcomes

  1. Systolic & Diastolic Arterial Blood Pressure

    Time frame: 12 hours

    measuring it pre-operative , intra-operative & post-operative

  2. Heart rate

    Time frame: 12 hours

    measuring HR per minute pre & intra & post operative

  3. Patient & Surgeon satisfaction

    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 .

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

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.

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