Vitreoretinal SurgeriesEarly Phase 1NCT06501352
Comparative Study Between Dexmedetomidine & Neostigmine as an Adjuvant to Local Anesthetic Mixture in Peribulbar Block in Vitreoretinal Surgeries
A Early Phase 1 study testing Dexmedetomidine, Neostigmine and Saline in people with Vitreoretinal Surgeries and Local Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Vitreoretinal Surgeries, Local Anesthesia
- What is being tested?
- Dexmedetomidine, Neostigmine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2023to 30 Mar 2024
- Phase
- Early 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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 .
Read the 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%)
- Conditions
- Vitreoretinal Surgeries, Local Anesthesia
- Being tested
- Dexmedetomidine, Neostigmine, Saline
- Keywords
- Dexmeditomedine, Neostagmine, Peribulbar block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Marcaine, Xylocaine, Hyaluronidase
Additive to Local anesthetic mixture
NeostigmineDrug
Also called Marcaine, Xylocaine, Hyaluronidase
Additive to Local anesthetic mixture
SalineDrug
Also called Marcaine, Xylocaine, Hyaluronidase
Control
| Study group | Role | What they receive |
|---|---|---|
| Dexmeditomedine group | Active comparator | Patients in this group will receive Dexmeditomedine in Local anesthesia mixture. Receives: Drug: Dexmedetomidine |
| Neostigmine group | Active comparator | Patients in this group will receive Neostigmine in Local anesthesia mixture. Receives: Drug: Neostigmine |
| Control group | Placebo comparator | Patients in this group will receive saline (placebo) in Local anesthesia mixture. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset & Duration of sensory and motor block
By minutes , Refers to the time from injection till patient will feel nothing in his eyes , then the time when he regain feeling again
Measured: 12 hours
Secondary outcomes (3)
Systolic & Diastolic Arterial Blood Pressure
measuring it pre-operative , intra-operative \& post-operative
Measured: 12 hours
Heart rate
measuring HR per minute pre \& intra \& post operative
Measured: 12 hours
Patient & Surgeon satisfaction
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 .
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start20 Jan 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreoretinal SurgeriesStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Hamdy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501352
- Sponsor's protocol ID
- Ain Shams University Hospitals
- Status last verified
- Jul 2024
- First submitted
- 10 Jan 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of work
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Dexmedetomidine & Neostigmine as an Adjuvant to Local Anesthetic Mixture in Peribulbar Block in Vitreoretinal Surgeries
- ClinicalTrials.gov ID
- NCT06501352
- Acronym / sponsor ID
- Ain Shams University Hospitals
- Conditions
- Vitreoretinal Surgeries, Local Anesthesia
- Keywords
- Dexmeditomedine, Neostagmine, Peribulbar block
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 15 Jul 2024 (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 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%)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmeditomedine group | Active comparator | Drug: DexmedetomidinePatients in this group will receive Dexmeditomedine in Local anesthesia mixture. |
| Neostigmine group | Active comparator | Drug: NeostigminePatients in this group will receive Neostigmine in Local anesthesia mixture. |
| Control group | Placebo comparator | Drug: SalinePatients in this group will receive saline (placebo) in Local anesthesia mixture. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| DexmedetomidineAlso: Marcaine, Xylocaine, HyaluronidaseAdditive to Local anesthetic mixture | Drug | Dexmeditomedine group |
| NeostigmineAlso: Marcaine, Xylocaine, HyaluronidaseAdditive to Local anesthetic mixture | Drug | Neostigmine group |
| SalineAlso: Marcaine, Xylocaine, HyaluronidaseControl | Drug | Control group |
Primary outcome
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
3 secondary outcomes
Systolic & Diastolic Arterial Blood Pressure
Time frame: 12 hours
Heart rate
Time frame: 12 hours
Patient & Surgeon satisfaction
Time frame: 12 hours
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 15 Jul 2024.
- Individual participant dataSharing planned: Yes. After completion of work
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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 Early Phase 1 study testing Dexmedetomidine, Neostigmine and Saline in people with Vitreoretinal Surgeries and Local Anesthesia, 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 4 inclusion and 5 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 15 Jul 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Onset & Duration of sensory and motor block (time frame: 12 hours). 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 15 Jul 2024.