Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Although topical anesthesia by eye drops for cataract surgery is a non-invasive technique but it may provide insufficient anesthesia which requires the intraoperative use of additional topical local anesthetics and raises the need for sedation.
The present study is constructed to evaluate the effect of pregabalin on sedation using dexmedetomidine for cataract surgery under topical anesthesia . In the dexmedetomidine-pregabalin group, the patients will be premedicated by pregabalin. In the placebo group (control group) the patients will be premedicated by placebo capsules. All patients will be sedated by dexmedetomidine. Sedation will be assessed as a primary outcome measurement where pain, vital signs, intraoperative and postoperative pain, total analgesic needs and side effects will be assessed as secondary outcome measurements.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | placebo oral capsule+ dexmedetomidine+topical anesthesia |
|
| Dexmedetomidine- Pregabalin | Active Comparator | Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine Injection | Drug | Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| sedation score changes | Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation. | baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| pain score changes | verbal pain score (VPS) from 0 = no pain to 10= the worst pain imaginable. scor ≥ 3 indicates need of analgesia | baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours |
| heart rate changes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Abd-Elazeem A Elbakry, MD | Assistant professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Cairo | Shebin El-kom | 32511 | Egypt |
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000069583 | Pregabalin |
| D000758 | Anesthesia |
| C005298 | benoxinate |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
The patients, the surgeons and the research team will be blinded to the randomization.
| Placebo oral capsule | Drug | placebo oral capsules |
|
|
| Pregabalin Oral Capsule | Drug | 150 mg pregabalin Oral Capsule |
|
|
| topical anesthesia | Drug | topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops |
|
|
beats/minute |
| baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours |
| arterial blood pressure changes | mmHg | baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours |
| arterial oxygen saturation | the percentage of hemoglobin saturation with oxygen in arterial blood. | baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours |
| respiratory rate | breath/minute | baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours |
| total dexmedetomidine consumption | ug | intraoperatively |
| Incidence of respiratory depression | percentage | from administering premedication till 24 hours postoperative. |
| Incidence of hypotension | percentage | from administering premedication till 24hours postoperative |
| Incidence of bradycardia | percentage | from administering premedication till 24hours postoperative |
| Incidence of ataxia | percentage | from administering premedication till 24hours postoperative |
| D005680 |
| gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000760 | Anesthesia and Analgesia |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |