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Completed

NCT Number: NCT06784843

Dexmedetomidine Versus Midazolam for Peribulbar Block

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez canal university

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block

Drug

Dexmedetomidine as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery

Other names: DEX

Midazolam as an adjuvant to local anesthesia for peribulbar block

Drug

Midazolam as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery

Other names: MID

Primary outcomes

  1. onset of motor block

    Time frame: 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 outcomes

  1. onset of sensory block

    Time frame: 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

  2. length of the motor block

    Time frame: 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

  3. length of the sensory block

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study 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

Acronym: peribulbar

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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