Dexmedetomidine Versus Midazolam for Peribulbar Block

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Drug: Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block; Drug: Midazolam as an adjuvant to local anesthesia for peribulbar block

• Registration Number: NCT06784843
• Lead Sponsor: Suez Canal University

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.

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-08-30
• Study Completion: 2024-09-30
• Study First Submitted: 2024-12-28
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-20
• Last Update Submitted: 2025-04-26
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
peribulbar block 1	Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block	Patients who were scheduled for cataract surgery under peribulbar block.
peribulbar block 2	Midazolam as an adjuvant to local anesthesia for peribulbar block	Patients who were scheduled for cataract surgery under peribulbar block.

Primary Outcome Measures

Name	Time	Method
onset of motor block	Intraoperative from the moment of local anesthesia injection until the moment of complete and full globe akinesia up to 1 hour	The period of time that passed after the local anesthetic mixture was injected before the eye globe was completely immobile

Secondary Outcome Measures

Name	Time	Method
onset of sensory block	Intraoperative from the moment of local anesthesia injection until the moment of complete insensitivity and absent reflexes of the eye up to 1 hour	the period of time following the local anesthetic mixture injection that resulted in total insensitivity and absent eye reflexes
length of the motor block	Periperative from the moment of complete and full globe akinesia until the moment of return back of eye movement up to 1 hour	The time it takes for the entire eye globe to return to free motion after experiencing akinesia
length of the sensory block	Periperative from the moment of complete areflexia until the moment of return back of sensation and reflexes up to 1 hour	The amount of time before the entire eye globe regains sensation after experiencing insensitivity and areflexia andreflexes

Trial Locations

Locations (1)

Suez canal university; 🇪🇬 Ismailia, Egypt