NCT06784843

Dexmedetomidine Versus Midazolam for Peribulbar Block

Dexmedetomidine Versus Midazolam as an Adjuvant to Local Anesthetic Mixture (Bupivacaine, Lidocaine, and Hyaluronidase) for Peribulbar Block During Cataract Surgery: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Suez Canal University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block	Dexmedetomidine as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery
DRUG	Midazolam as an adjuvant to local anesthesia for peribulbar block	Midazolam as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-08-30
• Completion: 2024-09-30
• First posted: 2025-01-20
• Last updated: 2025-04-30

Locations

1 site across 1 country: Egypt