Clinical trial NCT05692167: Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery
Official title: Dexmedetomidine as an Additive to Topical Versus Peribulbar Anesthesia for Cataract Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dexmedetomidine
Cataract Surgery
Peribulbar
Anesthesia
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 94
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for eye surgery

Exclusion Criteria:

* Patients who are younger than 18 years
* The usual contraindications for regional anesthesia such as patients refusing LA
* Clotting abnormalities
* Impaired mental status
* Allergy to any of the study medications
* patients had the severe cardiac disease
* chronic obstructive lung disease and a history of sleep apnea
* contraindications to the use of dexmedetomidine
* history or significant cardiovascular disease risk factors
* significant coronary artery disease or any known genetic predisposition
* history of any kind of drug allergy
* drug abuse
* psychological or other emotional problems
* special diet or lifestyle
* clinically significant abnormal findings in physical examination
* electrocardiographic (ECG) or laboratory screening
* known systemic disease requiring the use of anticoagulants.

Primary outcomes:
measure: Inadvertent eye movement
timeFrame: 2 hours postoperatively
Secondary outcomes:
measure: Anesthesia-related complications
timeFrame: 2 hours postoperatively
measure: Sedation level
timeFrame: 2 hours postoperatively
measure: pain during and after the surgery
timeFrame: 2 hours postoperatively
measure: Need for additional anesthesia during surgery and surgeon
timeFrame: During surgery
measure: Intraoperative difficulties
timeFrame: 2 hours postoperatively
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Mohammed Fouad Mohamed Algyar
state: Kafrelsheikh
Study officials:
affiliation: Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University
name: Mohammed F Algyar, MD
role: PRINCIPAL_INVESTIGATOR
References: