Conscious Sedation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDexmedetomidine Injection
Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion
DRUGPlacebo oral capsule
placebo oral capsules
DRUGPregabalin Oral Capsule
150 mg pregabalin Oral Capsule
topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops
Sponsors
Abd-Elazeem Abd-Elhameed Elbakry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patients, the surgeons and the research team will be blinded to the randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* American Society Of Anesthesiologists (ASA) I and II physical status. * Scheduled for cataract extraction under topical anesthesia.
Exclusion criteria
* Hepatic or renal impairment. * Taking chronic psychotropic medications. * Mental instability. * Morbid obesity. * Alcohol abuse. * Substance abuse. * Pregnant and lactating females. * History of allergy to the study drugs used
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sedation score changes | baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours | Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| heart rate changes | baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours | beats/minute |
| arterial blood pressure changes | baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours | mmHg |
| arterial oxygen saturation | baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours | the percentage of hemoglobin saturation with oxygen in arterial blood. |
| respiratory rate | baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours | breath/minute |
| pain score changes | baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours | verbal pain score (VPS) from 0 = no pain to 10= the worst pain imaginable. scor ≥ 3 indicates need of analgesia |
| Incidence of respiratory depression | from administering premedication till 24 hours postoperative. | percentage |
| Incidence of hypotension | from administering premedication till 24hours postoperative | percentage |
| Incidence of bradycardia | from administering premedication till 24hours postoperative | percentage |
| Incidence of ataxia | from administering premedication till 24hours postoperative | percentage |
| total dexmedetomidine consumption | intraoperatively | ug |
Countries
Egypt
Outcome results
None listed