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The aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical dexmedetomidine group | Active Comparator | Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical dexmedetomidine | Drug | Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inadvertent eye movement | Asses intra-ocular pressure (IOP) before injection of baseline and after a complete akinesia of the globe before surgical incision. | 2 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hours postoperatively |
| Sedation level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed F Algyar, MD | Contact | 00201111645345 | 047 | mohammad.algaiar@med.kfs.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mohammed F Algyar, MD | Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohammed Fouad Mohamed Algyar | Recruiting | Kafr ash Shaykh | Kafrelsheikh | 33516 | Egypt |
The data will be available under a reasonable request from the corresponding author
One year after the end of the study
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Reginal dexmedetomidine | Drug | Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block |
|
Numeric Rating Scale will be applied to grade the pain where 0 = no pain and 10 = extreme pain.
| 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. | 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 | 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 | 2 hours postoperatively |