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Dexmedetomidine Versus Midazolam for Peribulbar Block (peribulbar)

S

Suez Canal University

Status

Completed

Conditions

Cataract

Treatments

Drug: Midazolam as an adjuvant to local anesthesia for peribulbar block
Drug: Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block

Study type

Interventional

Funder types

Other

Identifiers

NCT06784843
peribulbar block

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

peribulbar block 1
Active Comparator group
Description:
Patients who were scheduled for cataract surgery under peribulbar block.
Treatment:
Drug: Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block
peribulbar block 2
Active Comparator group
Description:
Patients who were scheduled for cataract surgery under peribulbar block.
Treatment:
Drug: Midazolam as an adjuvant to local anesthesia for peribulbar block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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