Comparative Study Between Dexamethasone Versus Magnesium Sulfate in Medial Episcleral Technique in Keratopalsty Surgeries

NCT07847489 | Completed Phase 1 DMC

• 1 other identifier: FMASU R151/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work is to compare between the effects of addition of Dexamethasone versus magnesium sulfate to local anesthetic mixture in medial episcleral technique in keratoplasty operations

Conditions

Keratoplasty Regional Blocks

Keywords

Magnesium sulfate, Dexamethasone, Medial episcleral, Keratoplasty

Outcome Measures

Primary Outcomes (1)

• Primary outcome: Time to onset of accepted akinesia score and Need of supplemental injection in each group.

  Primary outcome: Motor blockade (akinesia) will be used as the main index of anesthesia effectiveness. It will be assessed using a 12 point score (12 point akinesia score) as: 0 (no movement), 1 (flicker), 2 (full movement) for the four recti muscles, levator palpebrae and orbicularis oculi (total score 12). Successful block is defined as an ocular motility score between 0 and 6. This score will be compared between the two groups 1, 5 and 10min after injection and at the end of the surgical procedures. The incidence of incomplete blockade (score \>6 after 10min from local anesthetic injection) with a need for supplemental injection will be compared between the two group Time to onset of accepted akinesia score. Need of supplemental injection in each group.

  6 months

Secondary Outcomes (1)

• Any perioperative complications will be recorded for each group. Numeric pain scale.

  6 months

Study Arms (3)

Group C:

PLACEBO COMPARATOR

Group C: local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 2ml normal saline.

Drug: Bupivacaine hydrochloride

Group Dexa

ACTIVE COMPARATOR

local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 4mg Dexamethasone in 1ml normal saline.

Drug: Dexamethasone

Group Mg:

ACTIVE COMPARATOR

local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 50 mg Magnesium sulfate in 1.5ml normal saline.

Drug: Magnesium sulfate

Interventions

Bupivacaine hydrochloride DRUG

local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 2ml normal saline.

Group C:

Dexamethasone DRUG

local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 4mg Dexamethasone in 1ml normal saline

Group Dexa

Magnesium sulfate DRUG

local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 50 mg Magnesium sulfate in 1.5ml normal saline.

Group Mg:

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: biological sex
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• o Physical Status: ASA (American society of Anesthesiologists) I - II patients.
• Both sexes.
• Axial length of the globe is 22-30mm

You may not qualify if:

• Patient under age of 21years.
• Infection at site of injection.
• Psychiatric illness or uncooperative patient.
• Coagulopathy, use of anticoagulants or antiplatelet therapy.
• Known allergies to local anesthetics drugs.
• Uncontrolled glaucoma.
• Recent surgical procedure on the same eye within one month.
• Single eyed.

Sponsors & Collaborators

• Ain Shams University: lead
• Self: collaborator

Study Sites (1)

Ain Shams University

Cairo, Abassia, 11517, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Dexamethasone; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: o Each group will receive a total volume of 10ml formed of: * Group C: local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 2ml normal saline. * Group Dexa: local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 4mg Dexamethasone in 1ml normal saline. * Group Mg: local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 50 mg Magnesium sulfate in 1.5ml normal saline.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: September 29, 2026
• Study Start: May 24, 2024
• Primary Completion: September 2, 2025
• Study Completion: December 2, 2025
• Last Updated: September 29, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)