DexmedetomidinePhase 2NCT05692167
Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery
A Phase 2 study testing Topical dexmedetomidine and Reginal dexmedetomidine in people with Dexmedetomidine and Cataract Surgery, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Dexmedetomidine, Cataract Surgery, Peribulbar
- What is being tested?
- Topical dexmedetomidine and Reginal dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2023to 15 Oct 2023
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for eye surgery
Who cannot join
- Patients who are younger than 18 years
- The usual contraindications for regional anesthesia such as patients refusing LA
- Clotting abnormalities
- Impaired mental status
- Allergy to any of the study medications
- patients had the severe cardiac disease
Show all 17Show fewer
- chronic obstructive lung disease and a history of sleep apnea
- contraindications to the use of dexmedetomidine
- history or significant cardiovascular disease risk factors
- significant coronary artery disease or any known genetic predisposition
- history of any kind of drug allergy
- drug abuse
- psychological or other emotional problems
- special diet or lifestyle
- clinically significant abnormal findings in physical examination
- electrocardiographic (ECG) or laboratory screening
- known systemic disease requiring the use of anticoagulants.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohammed Fouad Mohamed Algyar
Kafr ash Shaykh, Kafrelsheikh, 33516
Mohammed F Algyar, MD, 00201111645345 ext. 047, mohammad.algaiar@med.kfs.edu.eg
About this study
Official title: Dexmedetomidine as an Additive to Topical Versus Peribulbar Anesthesia for Cataract Surgery
The aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery
Read the detailed description
Ocular surgery may be performed under topical, regional, or general anesthesia. The first recorded use of regional anesthesia for surgery was the instillation of cocaine into the conjunctival sac in 1884 by an Austrian ophthalmologist.
Davis and Mandel in 1986 described the peribulbar block, peribulbar block has delayed onset and need a higher volume of local anesthetic (LA) than a retrobulbar block. But the peribulbar block is away from intra-conal space and so produce fewer complication.
Dexmedetomidine is used as adjuvant to LA drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. A more recent study using dexmedetomidine (50 μg) with the peribulbar block before cataract surgery demonstrated an IOP decrease similar to IV dexmedetomidine administration and greater than a peribulbar block without dexmedetomidine.
- Conditions
- Dexmedetomidine, Cataract Surgery, Peribulbar, Anesthesia
- Being tested
- Topical dexmedetomidine, Reginal dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical dexmedetomidineDrug
Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic
Reginal dexmedetomidineDrug
Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block
| Study group | Role | What they receive |
|---|---|---|
| Topical dexmedetomidine group | Active comparator | Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic Receives: Drug: Topical dexmedetomidine |
| Reginal dexmedetomidine group | Active comparator | Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block Receives: Drug: Reginal dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inadvertent eye movement
Asses intra-ocular pressure (IOP) before injection of baseline and after a complete akinesia of the globe before surgical incision.
Measured: 2 hours postoperatively
Secondary outcomes (5)
Anesthesia-related complications
The patients will be asked whether the cataract surgery was more or less painful than having the needle used for intravenous infusions inserted into the back of the hand.
Measured: 2 hours postoperatively
Sedation level
Numeric Rating Scale will be applied to grade the pain where 0 = no pain and 10 = extreme pain.
Measured: 2 hours postoperatively
pain during and after the surgery
Immediately after surgery, patients will be asked to grade the pain felt during the operation, including the pain felt after delivery of topical or peribulbar anaesthesia.
Measured: 2 hours postoperatively
Need for additional anesthesia during surgery and surgeon
The dose of additional needed anesthesia (fentanyl 0.5 µg/kg) during surgery will be recorded
Measured: During surgery
Intraoperative difficulties
The surgeon will also be requested to grade any difficulties encountered during surgery immediately after the operation, using a 4-point scale, where 1 = no difficulty and 4 = extremely difficult
Measured: 2 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start15 Jul 2023
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fouad Algyar, Kafrelsheikh University
- Investigators
- Mohammed F Algyar, MD, Principal investigator, Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692167
- Sponsor's protocol ID
- MKSU 50-11-3
- Status last verified
- Sep 2023
- First submitted
- 11 Jan 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available under a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as an Additive to Topical Versus Peribulbar Anesthesia for Cataract Surgery
- ClinicalTrials.gov ID
- NCT05692167
- Acronym / sponsor ID
- MKSU 50-11-3
- Conditions
- Dexmedetomidine, Cataract Surgery, Peribulbar, Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 20 Jan 2023 (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 study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery
Detailed description
Ocular surgery may be performed under topical, regional, or general anesthesia. The first recorded use of regional anesthesia for surgery was the instillation of cocaine into the conjunctival sac in 1884 by an Austrian ophthalmologist.
Davis and Mandel in 1986 described the peribulbar block, peribulbar block has delayed onset and need a higher volume of local anesthetic (LA) than a retrobulbar block. But the peribulbar block is away from intra-conal space and so produce fewer complication.
Dexmedetomidine is used as adjuvant to LA drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. A more recent study using dexmedetomidine (50 μg) with the peribulbar block before cataract surgery demonstrated an IOP decrease similar to IV dexmedetomidine administration and greater than a peribulbar block without dexmedetomidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical dexmedetomidine group | Active comparator | Drug: Topical dexmedetomidinePatients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic |
| Reginal dexmedetomidine group | Active comparator | Drug: Reginal dexmedetomidinePatients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for eye surgery
Key exclusion criteria (17 listed)
- Patients who are younger than 18 years
- The usual contraindications for regional anesthesia such as patients refusing LA
- Clotting abnormalities
- Impaired mental status
- Allergy to any of the study medications
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 |
|---|---|---|
| Topical dexmedetomidinePatients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic | Drug | Topical dexmedetomidine group |
| Reginal dexmedetomidinePatients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block | Drug | Reginal dexmedetomidine group |
Primary outcome
Inadvertent eye movement
Time frame: 2 hours postoperatively
Asses intra-ocular pressure (IOP) before injection of baseline and after a complete akinesia of the globe before surgical incision.
5 secondary outcomes
Anesthesia-related complications
Time frame: 2 hours postoperatively
Sedation level
Time frame: 2 hours postoperatively
pain during and after the surgery
Time frame: 2 hours postoperatively
Need for additional anesthesia during surgery and surgeon
Time frame: During surgery
Intraoperative difficulties
Time frame: 2 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Yes. The data will be available under a reasonable request from the corresponding author
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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.
Mohammed F Algyar, MD principal investigator
Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical dexmedetomidine and Reginal dexmedetomidine in people with Dexmedetomidine and Cataract Surgery, run by Kafrelsheikh 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 1 inclusion and 17 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 7 Sep 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mohammed F Algyar, MD (00201111645345 ext. 047, mohammad.algaiar@med.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inadvertent eye movement (time frame: 2 hours postoperatively). 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 7 Sep 2023.