Clinical trial NCT03735368: Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery
Official title: Dexmedetomidine With or Without Pregabalin Premedication for Conscious Sedation During Cataract Surgery Under Topical Anesthesia. A Randomized Double-blind Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Conscious Sedation
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: sedation score changes
timeFrame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Secondary outcomes:
measure: pain score changes
timeFrame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
measure: heart rate changes
timeFrame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
measure: arterial blood pressure changes
timeFrame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
measure: arterial oxygen saturation
timeFrame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
measure: respiratory rate
timeFrame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
measure: total dexmedetomidine consumption
timeFrame: intraoperatively
measure: Incidence of respiratory depression
timeFrame: from administering premedication till 24 hours postoperative.
measure: Incidence of hypotension
timeFrame: from administering premedication till 24hours postoperative
measure: Incidence of bradycardia
timeFrame: from administering premedication till 24hours postoperative
measure: Incidence of ataxia
timeFrame: from administering premedication till 24hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
state: Shebin El-kom
Study officials:
affiliation: Assistant professor
name: Abd-Elazeem A Elbakry, MD
role: PRINCIPAL_INVESTIGATOR
References: