CataractperibulbarNCT06784843
Dexmedetomidine Versus Midazolam for Peribulbar Block
A study testing Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block and Midazolam as an adjuvant to local anesthesia for peribulbar block in people with Cataract, run by Suez Canal University at 1 site in Egypt.
Trial summary
50 patients of both sexes, ages 18 to 75, who were scheduled for cataract surgery and had physical status I or II according to the American Society of Anesthesiologists were included in this study. After induction of general anesthesia, all patients received peribulbar block. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cataract
- What is being tested?
- Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block and Midazolam as an adjuvant to local anesthesia for peribulbar block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 30 Sep 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of cataract Disease
- Scheduled for cataract surgery
- American Society of Anesthesiologists physical status I or II.
Who cannot join
- History of allergy to any of the study medications
- Had impaired mental status
- Had coagulation abnormalities
- Had severe cardiac disease
- Had chronic obstructive lung disease
- Had a history of sleep apnea
- Refused to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Midazolam as an Adjuvant to Local Anesthetic Mixture (Bupivacaine, Lidocaine, and Hyaluronidase) for Peribulbar Block During Cataract Surgery: A Randomized Controlled Trial
50 patients of both sexes, ages 18 to 75, who were scheduled for cataract surgery and had physical status I or II according to the American Society of Anesthesiologists were included in this study.
After induction of general anesthesia, all patients received peribulbar block. In group A (midazolam group), 25 patients received midazolam. In group B (dexmedetomidine group), 25 patients received dexmedetomidine.
Read the detailed description
Background: Peribulbar blocks are commonly used for cataract surgery, providing effective anesthesia with reduced recovery time. The addition of sedative agents, such as dexmedetomidine or midazolam, may enhance the anesthetic effect and patient comfort while maintaining hemodynamic stability. However, the optimal sedative agent for use in this context remains uncertain.
Objective: This study aimed to compare the efficacy and safety of dexmedetomidine and midazolam as adjuvants to local anesthetic in peribulbar blocks for cataract surgery.
Methods: A randomized, double-blind clinical trial included 50 patients aged 18-75 years with the American Society of Anesthesiologists physical status I-II who were scheduled for cataract surgery under peribulbar block. Participants were randomly allocated to two groups: Group A received midazolam (1 mg), and Group B received dexmedetomidine (50 µg), combined with a standard mixture of local anesthetics. The primary outcomes included the onset and duration of motor and sensory block and lid akinesia. Secondary outcomes assessed the quality of motor and sensory block, lid akinesia using the Ocular Anesthesia Scoring System, sedation levels using the Ramsay Sedation Score, the occurrence of local or systemic complications, and satisfaction levels reported by both patients and surgeons.
Keywords: dexmedetomidine; midazolam; peribulbar block; cataract surgery.
- Conditions
- Cataract
- Being tested
- Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block, Midazolam as an adjuvant to local anesthesia for peribulbar block
- Keywords
- dexmedetomidine, midazolam, peribulbar block, cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine as an adjuvant to local anesthesia for peribulbar blockDrug
Also called DEX
Dexmedetomidine as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery
Midazolam as an adjuvant to local anesthesia for peribulbar blockDrug
Also called MID
Midazolam as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| peribulbar block 1 | Active comparator | Patients who were scheduled for cataract surgery under peribulbar block. Receives: Drug: Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block |
| peribulbar block 2 | Active comparator | Patients who were scheduled for cataract surgery under peribulbar block. Receives: Drug: Midazolam as an adjuvant to local anesthesia for peribulbar block |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset of motor block
The period of time that passed after the local anesthetic mixture was injected before the eye globe was completely immobile
Measured: Intraoperative from the moment of local anesthesia injection until the moment of complete and full globe akinesia up to 1 hour
Secondary outcomes (3)
onset of sensory block
the period of time following the local anesthetic mixture injection that resulted in total insensitivity and absent eye reflexes
Measured: Intraoperative from the moment of local anesthesia injection until the moment of complete insensitivity and absent reflexes of the eye up to 1 hour
length of the motor block
The time it takes for the entire eye globe to return to free motion after experiencing akinesia
Measured: Periperative from the moment of complete and full globe akinesia until the moment of return back of eye movement up to 1 hour
length of the sensory block
The amount of time before the entire eye globe regains sensation after experiencing insensitivity and areflexia andreflexes
Measured: Periperative from the moment of complete areflexia until the moment of return back of sensation and reflexes up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Dec 2023
- Primary completion30 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
- Investigators
- Abdelrhman Alshawadfy, MD, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784843
- Sponsor's protocol ID
- peribulbar block
- Acronym
- peribulbar
- Status last verified
- Jan 2025
- First submitted
- 28 Dec 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Midazolam as an Adjuvant to Local Anesthetic Mixture (Bupivacaine, Lidocaine, and Hyaluronidase) for Peribulbar Block During Cataract Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06784843
- Acronym / sponsor ID
- peribulbar / peribulbar block
- Conditions
- Cataract
- Keywords
- dexmedetomidine, midazolam, peribulbar block, cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 20 Jan 2025 (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.
50 patients of both sexes, ages 18 to 75, who were scheduled for cataract surgery and had physical status I or II according to the American Society of Anesthesiologists were included in this study.
After induction of general anesthesia, all patients received peribulbar block. In group A (midazolam group), 25 patients received midazolam. In group B (dexmedetomidine group), 25 patients received dexmedetomidine.
Detailed description
Background: Peribulbar blocks are commonly used for cataract surgery, providing effective anesthesia with reduced recovery time. The addition of sedative agents, such as dexmedetomidine or midazolam, may enhance the anesthetic effect and patient comfort while maintaining hemodynamic stability. However, the optimal sedative agent for use in this context remains uncertain.
Objective: This study aimed to compare the efficacy and safety of dexmedetomidine and midazolam as adjuvants to local anesthetic in peribulbar blocks for cataract surgery.
Methods: A randomized, double-blind clinical trial included 50 patients aged 18-75 years with the American Society of Anesthesiologists physical status I-II who were scheduled for cataract surgery under peribulbar block. Participants were randomly allocated to two groups: Group A received midazolam (1 mg), and Group B received dexmedetomidine (50 µg), combined with a standard mixture of local anesthetics. The primary outcomes included the onset and duration of motor and sensory block and lid akinesia. Secondary outcomes assessed the quality of motor and sensory block, lid akinesia using the Ocular Anesthesia Scoring System, sedation levels using the Ramsay Sedation Score, the occurrence of local or systemic complications, and satisfaction levels reported by both patients and surgeons.
Keywords: dexmedetomidine; midazolam; peribulbar block; cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 2 groups
| Arm | Type | Receives |
|---|---|---|
| peribulbar block 1 | Active comparator | Drug: Dexmedetomidine as an adjuvant to local anesthesia for peribulbar blockPatients who were scheduled for cataract surgery under peribulbar block. |
| peribulbar block 2 | Active comparator | Drug: Midazolam as an adjuvant to local anesthesia for peribulbar blockPatients who were scheduled for cataract surgery under peribulbar block. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of cataract Disease
- Scheduled for cataract surgery
- American Society of Anesthesiologists physical status I or II.
Key exclusion criteria (7 listed)
- History of allergy to any of the study medications
- Had impaired mental status
- Had coagulation abnormalities
- Had severe cardiac disease
- Had chronic obstructive lung disease
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 |
|---|---|---|
| Dexmedetomidine as an adjuvant to local anesthesia for peribulbar blockAlso: DEXDexmedetomidine as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery | Drug | peribulbar block 1 |
| Midazolam as an adjuvant to local anesthesia for peribulbar blockAlso: MIDMidazolam as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery | Drug | peribulbar block 2 |
Primary outcome
onset of motor block
Time frame: Intraoperative from the moment of local anesthesia injection until the moment of complete and full globe akinesia up to 1 hour
The period of time that passed after the local anesthetic mixture was injected before the eye globe was completely immobile
3 secondary outcomes
onset of sensory block
Time frame: Intraoperative from the moment of local anesthesia injection until the moment of complete insensitivity and absent reflexes of the eye up to 1 hour
length of the motor block
Time frame: Periperative from the moment of complete and full globe akinesia until the moment of return back of eye movement up to 1 hour
length of the sensory block
Time frame: Periperative from the moment of complete areflexia until the moment of return back of sensation and reflexes up to 1 hour
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 30 Apr 2025.
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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.
Abdelrhman Alshawadfy, MD principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block and Midazolam as an adjuvant to local anesthesia for peribulbar block in people with Cataract, run by Suez Canal 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 3 inclusion and 7 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 30 Apr 2025. 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?
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 of motor block (time frame: Intraoperative from the moment of local anesthesia injection until the moment of complete and full globe akinesia up to 1 hour). 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 30 Apr 2025.