KeratoplastyPhase 1NCT07847489
Comparative Study Between Dexamethasone Versus Magnesium Sulfate in Medial Episcleral Technique in Keratopalsty Surgeries
A Phase 1 study testing Bupivacaine hydrochloride, Dexamethasone and Magnesium sulfate in people with Keratoplasty and Regional Block, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoplasty, Regional Block
- What is being tested?
- Bupivacaine hydrochloride, Dexamethasone and Magnesium sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 24 May 2024to 2 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- o Physical Status: ASA (American society of Anesthesiologists) I - II patients.
- Both sexes.
- Axial length of the globe is 22-30mm
- Exclusion Criteria:o Refusal of procedure or participation in the study.
- Patient under age of 21years.
- Infection at site of injection.
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Different Additives to Local Anesthetics: Dexamethasone Versus Magnesium Sulfate in Medial Episcleral Technique in Keratopalsty Surgeries
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
Read the detailed description
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 Pilot study will be done on 60 patients (20/group).
-The patients will be randomized into 3 equal groups by computer generated randomization in which all patients will receive medial canthus episcleral technique with local anesthetic mixture with different additives.
preoperative investigation as CBC ,,LFT KFT, . coagulation profile , ECG and echo for the risky patients ASA III. preoperative medication .antiemetic dexamesthasone 0.06mg\kg sedative midazolame 0.15mg\kg given before the the block within 20-30 minutes . patient is connected to full ASA monitor ECG ,SPO2 probe NIBP and connected to nasal cannula 3l\m of oxygen The procedure is done in the operating rooms (OR) under complete aseptic technique.
Preparations that will be used for each patient are:
- Sterile towels, sponges, 4-inch gauze packs and povidone iodine 5% for sterilization, sterile gloves, 25Gx5/8 inch needle and 25Gx1inch needle
- The study drugs (commercially available forms) that will be used are:
- A 20 ml vial of 0.5% (Bupivacaine hydrochloride) equivalent to 5mg/ml
- A 50ml vial of 2% (Lidocaine hydrochloride) equivalent to 20mg/ml with 1500IU Hyaluronidase dissolved in the vial (30IU/ml).
- 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.
Assessment of the block for each group:
- 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).
- Sensory assessment of each block is done by numeric pain rating scale on a 10 points-scale during surgery being 0 indicating no pain while 10 representing the worst possible pain.
- Conditions
- Keratoplasty, Regional Block
- Being tested
- Bupivacaine hydrochloride, Dexamethasone, Magnesium sulfate
- Keywords
- Keratoplasty, Medial episclera, Dexamethasone, Magnesium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine hydrochlorideDrug
local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 2ml normal saline.
DexamethasoneDrug
local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 4mg Dexamethasone in 1ml normal saline
Magnesium sulfateDrug
local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 50 mg Magnesium sulfate in 1.5ml normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Group C: | Placebo comparator | Group C: local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 2ml normal saline. Receives: 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. Receives: 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. Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Any perioperative complications will be recorded for each group. Numeric pain scale.
Any perioperative complications will be recorded for each group. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" while 10 representing the worst possible pain.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start24 May 2024
- Primary completion2 Sep 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoplastyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Self
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847489
- Sponsor's protocol ID
- FMASU R151/2024
- Status last verified
- May 2024
- First submitted
- 18 Dec 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Different Additives to Local Anesthetics: Dexamethasone Versus Magnesium Sulfate in Medial Episcleral Technique in Keratopalsty Surgeries
- ClinicalTrials.gov ID
- NCT07847489
- Acronym / sponsor ID
- FMASU R151/2024
- Conditions
- Keratoplasty, Regional Block
- Keywords
- Keratoplasty, Medial episclera, Dexamethasone, Magnesium sulfate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Self
- Study start
- 24 May 2024 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 Pilot study will be done on 60 patients (20/group).
-The patients will be randomized into 3 equal groups by computer generated randomization in which all patients will receive medial canthus episcleral technique with local anesthetic mixture with different additives.
preoperative investigation as CBC ,,LFT KFT, . coagulation profile , ECG and echo for the risky patients ASA III. preoperative medication .antiemetic dexamesthasone 0.06mg\kg sedative midazolame 0.15mg\kg given before the the block within 20-30 minutes . patient is connected to full ASA monitor ECG ,SPO2 probe NIBP and connected to nasal cannula 3l\m of oxygen The procedure is done in the operating rooms (OR) under complete aseptic technique.
Preparations that will be used for each patient are:
- Sterile towels, sponges, 4-inch gauze packs and povidone iodine 5% for sterilization, sterile gloves, 25Gx5/8 inch needle and 25Gx1inch needle
- The study drugs (commercially available forms) that will be used are:
- A 20 ml vial of 0.5% (Bupivacaine hydrochloride) equivalent to 5mg/ml
- A 50ml vial of 2% (Lidocaine hydrochloride) equivalent to 20mg/ml with 1500IU Hyaluronidase dissolved in the vial (30IU/ml).
- 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.
Assessment of the block for each group:
- 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).
- Sensory assessment of each block is done by numeric pain rating scale on a 10 points-scale during surgery being 0 indicating no pain while 10 representing the worst possible pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group C: | Placebo comparator | Drug: Bupivacaine hydrochlorideGroup C: local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 2ml normal saline. |
| Group Dexa | Active comparator | Drug: Dexamethasonelocal anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 4mg Dexamethasone in 1ml normal saline. |
| Group Mg: | Active comparator | Drug: Magnesium sulfatelocal anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 50 mg Magnesium sulfate in 1.5ml normal saline. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- o Physical Status: ASA (American society of Anesthesiologists) I - II patients.
- Exclusion Criteria:o Refusal of procedure or participation in the study.
- Patient under age of 21years.
- Infection at site of injection.
- Psychiatric illness or uncooperative patient.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine hydrochloridelocal anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 2ml normal saline. | Drug | Group C: |
| Dexamethasonelocal anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 4mg Dexamethasone in 1ml normal saline | Drug | Group Dexa |
| Magnesium sulfatelocal anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 50 mg Magnesium sulfate in 1.5ml normal saline. | Drug | Group Mg: |
Primary outcome
Primary outcome: Time to onset of accepted akinesia score and Need of supplemental injection in each group.
Time frame: 6 months
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.
1 secondary outcome
Any perioperative complications will be recorded for each group. Numeric pain scale.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine hydrochloride, Dexamethasone and Magnesium sulfate in people with Keratoplasty and Regional Block, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Time to onset of accepted akinesia score and Need of supplemental injection in each group. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.