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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06784843
Acronym
peribulbar
Enrollment
50
Registered
2025-01-20
Start date
2023-12-01
Completion date
2024-09-30
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

dexmedetomidine, midazolam, peribulbar block, cataract

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.

Interventions

DRUGDexmedetomidine 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

DRUGMidazolam 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

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

The allocation sequence was concealed using sealed opaque envelopes . Patients and the operators were masked to the allocation of the interventions.

Intervention model description

2 groups

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
onset of motor blockIntraoperative from the moment of local anesthesia injection until the moment of complete and full globe akinesia up to 1 hourThe period of time that passed after the local anesthetic mixture was injected before the eye globe was completely immobile

Secondary

MeasureTime frameDescription
onset of sensory blockIntraoperative from the moment of local anesthesia injection until the moment of complete insensitivity and absent reflexes of the eye up to 1 hourthe period of time following the local anesthetic mixture injection that resulted in total insensitivity and absent eye reflexes
length of the motor blockPeriperative from the moment of complete and full globe akinesia until the moment of return back of eye movement up to 1 hourThe time it takes for the entire eye globe to return to free motion after experiencing akinesia
length of the sensory blockPeriperative from the moment of complete areflexia until the moment of return back of sensation and reflexes up to 1 hourThe amount of time before the entire eye globe regains sensation after experiencing insensitivity and areflexia andreflexes

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026