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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peribulbar block 1 | Active Comparator | Patients who were scheduled for cataract surgery under peribulbar block. |
|
| peribulbar block 2 | Active Comparator | Patients who were scheduled for cataract surgery under peribulbar block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block | Drug | Dexmedetomidine as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| onset of motor block | The period of time that passed after the local anesthetic mixture was injected before the eye globe was completely immobile | Intraoperative from the moment of local anesthesia injection until the moment of complete and full globe akinesia up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| onset of sensory block | the period of time following the local anesthetic mixture injection that resulted in total insensitivity and absent eye reflexes | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdelrhman Alshawadfy, MD | Suez Canal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez canal university | Ismailia | Egypt |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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2 groups
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The allocation sequence was concealed using sealed opaque envelopes . Patients and the operators were masked to the allocation of the interventions.
|
| Midazolam as an adjuvant to local anesthesia for peribulbar block | Drug | Midazolam as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery |
|
|
The time it takes for the entire eye globe to return to free motion after experiencing akinesia |
| 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 | Periperative from the moment of complete areflexia until the moment of return back of sensation and reflexes up to 1 hour |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |