Dexmedetomidine Versus Midazolam for Peribulbar Block (peribulbar)

April 26, 2025 updated by: Abdelrhman Alshawadfy, Suez Canal University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Ismailia, Egypt
        • Suez Canal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: peribulbar block 1
Patients who were scheduled for cataract surgery under peribulbar block.
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
Other Names:
  • DEX
Active Comparator: peribulbar block 2
Patients who were scheduled for cataract surgery under peribulbar block.
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
Other Names:
  • MID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intraoperative from the moment of local anesthesia injection until the moment of complete and full globe akinesia up to 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intraoperative from the moment of local anesthesia injection until the moment of complete insensitivity and absent reflexes of the eye up to 1 hour
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
Periperative from the moment of complete and full globe akinesia until the moment of return back of eye movement up to 1 hour
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
Periperative from the moment of complete areflexia until the moment of return back of sensation and reflexes up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Principal Investigator: Abdelrhman Alshawadfy, MD, Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

December 28, 2024

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • peribulbar block

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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