Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery
- Conditions
- Conscious Sedation
- Interventions
- Drug: Placebo oral capsuleDrug: topical anesthesia
- Registration Number
- NCT03735368
- Lead Sponsor
- Abd-Elazeem Abd-Elhameed Elbakry
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- American Society Of Anesthesiologists (ASA) I and II physical status.
- Scheduled for cataract extraction under topical anesthesia.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexmedetomidine- Pregabalin Dexmedetomidine Injection Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia Dexmedetomidine- Pregabalin Pregabalin Oral Capsule Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia Dexmedetomidine- Pregabalin topical anesthesia Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia Control Dexmedetomidine Injection placebo oral capsule+ dexmedetomidine+topical anesthesia Control Placebo oral capsule placebo oral capsule+ dexmedetomidine+topical anesthesia Control topical anesthesia placebo oral capsule+ dexmedetomidine+topical anesthesia
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
heart rate changes baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours beats/minute
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.
Incidence of ataxia from administering premedication till 24hours postoperative percentage
arterial blood pressure changes baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours mmHg
Incidence of hypotension from administering premedication till 24hours postoperative percentage
respiratory rate baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours breath/minute
total dexmedetomidine consumption intraoperatively ug
Incidence of respiratory depression from administering premedication till 24 hours postoperative. percentage
Incidence of bradycardia from administering premedication till 24hours postoperative percentage
Trial Locations
- Locations (1)
Faculty of Medicine
🇪🇬Cairo, Shebin El-kom, Egypt