Clinical trial NCT06784843: Dexmedetomidine Versus Midazolam for Peribulbar Block
Official title: Dexmedetomidine Versus Midazolam as an Adjuvant to Local Anesthetic Mixture (Bupivacaine, Lidocaine, and Hyaluronidase) for Peribulbar Block During Cataract Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: dexmedetomidine
midazolam
peribulbar block
cataract
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups
Primary purpose: TREATMENT

Brief summary: 50 patients of both sexes, ages 18 to 75, who were scheduled for cataract surgery and had physical status I or II according to the American Society of Anesthesiologists were included in this study.

After induction of general anesthesia, all patients received peribulbar block. In group A (midazolam group), 25 patients received midazolam. In group B (dexmedetomidine group), 25 patients received dexmedetomidine.

Detailed description: Background: Peribulbar blocks are commonly used for cataract surgery, providing effective anesthesia with reduced recovery time. The addition of sedative agents, such as dexmedetomidine or midazolam, may enhance the anesthetic effect and patient comfort while maintaining hemodynamic stability. However, the optimal sedative agent for use in this context remains uncertain.

Objective: This study aimed to compare the efficacy and safety of dexmedetomidine and midazolam as adjuvants to local anesthetic in peribulbar blocks for cataract surgery.

Methods: A randomized, double-blind clinical trial included 50 patients aged 18-75 years with the American Society of Anesthesiologists physical status I-II who were scheduled for cataract surgery under peribulbar block. Participants were randomly allocated to two groups: Group A received midazolam (1 mg), and Group B received dexmedetomidine (50 µg), combined with a standard mixture of local anesthetics. The primary outcomes included the onset and duration of motor and sensory block and lid akinesia. Secondary outcomes assessed the quality of motor and sensory block, lid akinesia using the Ocular Anesthesia Scoring System, sedation levels using the Ramsay Sedation Score, the occurrence of local or systemic complications, and satisfaction levels reported by both patients and surgeons.

Keywords: dexmedetomidine; midazolam; peribulbar block; cataract surgery.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cataract Disease
* Scheduled for cataract surgery
* American Society of Anesthesiologists physical status I or II.

Exclusion Criteria:

* History of allergy to any of the study medications
* Had impaired mental status
* Had coagulation abnormalities
* Had severe cardiac disease
* Had chronic obstructive lung disease
* Had a history of sleep apnea
* Refused to participate.

Primary outcomes:
measure: onset of motor block
timeFrame: Intraoperative from the moment of local anesthesia injection until the moment of complete and full globe akinesia up to 1 hour
Secondary outcomes:
measure: onset of sensory block
timeFrame: Intraoperative from the moment of local anesthesia injection until the moment of complete insensitivity and absent reflexes of the eye up to 1 hour
measure: length of the motor block
timeFrame: Periperative from the moment of complete and full globe akinesia until the moment of return back of eye movement up to 1 hour
measure: length of the sensory block
timeFrame: Periperative from the moment of complete areflexia until the moment of return back of sensation and reflexes up to 1 hour
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez canal university
Study officials:
affiliation: Suez Canal University
name: Abdelrhman Alshawadfy, MD
role: PRINCIPAL_INVESTIGATOR
References: