Long-Eye SurgeriesNCT06583811
Remifentanil and Remimazolam to Limit Patient Movement
A study testing Remifentanil in people with Long-Eye Surgeries, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Local anesthetics (LA) may be administered by injection (retrobulbar, peribulbar, subconjunctival, lid, or facial block) or by instillation (topical anesthesia), Considerable drawbacks of local anesthesia in these patients include the fact that a few patients can remain comfortable on an operating table for procedures… Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Long-Eye Surgeries
- What is being tested?
- Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2024to 10 Jan 2025
- Phase
- Interventional
- 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 40 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age > 40 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Undergoing long-eye surgeries under local anesthesia using peribulbar block with an expected surgical time of more than one hour.
Who cannot join
- Patients on aspirin or anticoagulants.
- Allergy to any study medication.
- Drug abuse.
- Uncontrolled hypertension.
- Hyperthyroidism.
- Frequent cough.
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- Impaired hearing.
- Severe liver and kidney dysfunction.
- Neurological or psychological disorders.
- Partial or failed block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remifentanil and Remimazolam to Limit Patient Movement During Long-Eye Surgeries Under Local Anesthesia
Local anesthetics (LA) may be administered by injection (retrobulbar, peribulbar, subconjunctival, lid, or facial block) or by instillation (topical anesthesia), Considerable drawbacks of local anesthesia in these patients include the fact that a few patients can remain comfortable on an operating table for procedures that exceed two or three hours.
Sedation may be helpful with LA to decrease the experience of discomfort, movement and anxiety, which may in turn positively influence hemodynamic parameters, patient satisfaction, and overall improve surgical safety. Sedatives used in eye surgeries include benzodiazepines, opioids, alpha-adrenoceptor agonists, and propofol.
Read the detailed description
Ophthalmic surgery is a precise surgical procedure that requires absolute immobilization. Many ophthalmic procedures can be performed safely in an outpatient setting, using local anesthesia.
Propofol is currently the most commonly used intravenous anesthetic. It has a rapid onset of action, a short half-life and is associated with rapid recovery of cognitive ability. However, propofol can lead to injection pain, propofol infusion syndrome, and hemodynamic and respiratory depression. Therefore, there is a need for new anesthetic drugs with high efficacy and fewer side effects while providing stable and controllable anesthesia.
Remifentanil is a short-acting esterase metabolized opioid with analgesic and sedative effects. Its half-life is about 5-10 min so that it can be titrated closely in response to changes in intraoperative requirements and with a low risk of accumulation.
Remimazolam is a novel ultrashort-acting benzodiazepine agonist that works on γ-aminobutyric acid type A (GABA-A) receptors to reduce neuronal excitation and thereby achieve hypoactivity and sedation in the body. Remimazolam is metabolized by a nonspecific esterase, and the metabolite has no pharmacological effect, which allows prolonged infusion without accumulation.
It provides rapid anesthesia and arousal while stabilizing hemodynamics and produces less depression of respiration, making it more suitable for use in elderly and hemodynamically unstable patients.
- Conditions
- Long-Eye Surgeries
- Being tested
- Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called emimazolam
to compare remifentanil and remimazolam to limit patient movement during long-eye surgeries under local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Remifentanil Group | Active comparator | About 35 Patients will receive Remifentanil bolus of 1 μg/kg over 30 seconds followed by a continuous infusion of 0.03-0.05 μg/kg/min. Receives: Drug: Remifentanil |
| Group B: Remimazolam Group | Active comparator | About 35 Patients will receive remimazolam bolus of 0.2mg/kg followed by a continuous infusion of 0.3-0.5 μg/kg/h. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye Movement
Incidence of patients who are not moving their Eyes during long eye surgery
Measured: from 0 hours to 4 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start10 Jul 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-Eye SurgeriesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583811
- Sponsor's protocol ID
- Remifentanil and Remimazolam
- Status last verified
- Jul 2024
- First submitted
- 30 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil and Remimazolam to Limit Patient Movement During Long-Eye Surgeries Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT06583811
- Acronym / sponsor ID
- Remifentanil and Remimazolam
- Conditions
- Long-Eye Surgeries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 4 Sep 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.
Local anesthetics (LA) may be administered by injection (retrobulbar, peribulbar, subconjunctival, lid, or facial block) or by instillation (topical anesthesia), Considerable drawbacks of local anesthesia in these patients include the fact that a few patients can remain comfortable on an operating table for procedures that exceed two or three hours.
Sedation may be helpful with LA to decrease the experience of discomfort, movement and anxiety, which may in turn positively influence hemodynamic parameters, patient satisfaction, and overall improve surgical safety. Sedatives used in eye surgeries include benzodiazepines, opioids, alpha-adrenoceptor agonists, and propofol.
Detailed description
Ophthalmic surgery is a precise surgical procedure that requires absolute immobilization. Many ophthalmic procedures can be performed safely in an outpatient setting, using local anesthesia.
Propofol is currently the most commonly used intravenous anesthetic. It has a rapid onset of action, a short half-life and is associated with rapid recovery of cognitive ability. However, propofol can lead to injection pain, propofol infusion syndrome, and hemodynamic and respiratory depression. Therefore, there is a need for new anesthetic drugs with high efficacy and fewer side effects while providing stable and controllable anesthesia.
Remifentanil is a short-acting esterase metabolized opioid with analgesic and sedative effects. Its half-life is about 5-10 min so that it can be titrated closely in response to changes in intraoperative requirements and with a low risk of accumulation.
Remimazolam is a novel ultrashort-acting benzodiazepine agonist that works on γ-aminobutyric acid type A (GABA-A) receptors to reduce neuronal excitation and thereby achieve hypoactivity and sedation in the body. Remimazolam is metabolized by a nonspecific esterase, and the metabolite has no pharmacological effect, which allows prolonged infusion without accumulation.
It provides rapid anesthesia and arousal while stabilizing hemodynamics and produces less depression of respiration, making it more suitable for use in elderly and hemodynamically unstable patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Remifentanil Group | Active comparator | Drug: RemifentanilAbout 35 Patients will receive Remifentanil bolus of 1 μg/kg over 30 seconds followed by a continuous infusion of 0.03-0.05 μg/kg/min. |
| Group B: Remimazolam Group | Active comparator | Drug: RemifentanilAbout 35 Patients will receive remimazolam bolus of 0.2mg/kg followed by a continuous infusion of 0.3-0.5 μg/kg/h. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age > 40 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Undergoing long-eye surgeries under local anesthesia using peribulbar block with an expected surgical time of more than one hour.
Key exclusion criteria (10 listed)
- Patients on aspirin or anticoagulants.
- Allergy to any study medication.
- Drug abuse.
- Uncontrolled hypertension.
- Hyperthyroidism.
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 |
|---|---|---|
| RemifentanilAlso: emimazolamto compare remifentanil and remimazolam to limit patient movement during long-eye surgeries under local anesthesia. | Drug | Group A: Remifentanil Group, Group B: Remimazolam Group |
Primary outcome
Eye Movement
Time frame: from 0 hours to 4 hours after the procedure
Incidence of patients who are not moving their Eyes during long eye surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil in people with Long-Eye Surgeries, run by Egymedicalpedia 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 10 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: status not confirmed, as of the sponsor's last update on 4 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M. Elnagar, M.D (+201007529357, Ahmed.elnaggar@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye Movement (time frame: from 0 hours to 4 hours after the procedure). 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 4 Sep 2024.