Dexmedetomidine Versus Midazolam for Peribulbar Block

NCT06784843 | Completed

• 1 other identifier: peribulbar block
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

dexmedetomidine; midazolam; peribulbar block; cataract

Outcome Measures

Primary Outcomes (1)

• onset of motor block

  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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

peribulbar block 1

ACTIVE COMPARATOR

Patients who were scheduled for cataract surgery under peribulbar block.

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

peribulbar block 2

ACTIVE COMPARATOR

Patients who were scheduled for cataract surgery under peribulbar block.

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

Interventions

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

Also known as: DEX

peribulbar block 1

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

Also known as: MID

peribulbar block 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of cataract Disease
• Scheduled for cataract surgery
• American Society of Anesthesiologists physical status I or II.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez canal university

Ismailia, Egypt

Location

MeSH Terms

Conditions

Cataract

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Abdelrhman Alshawadfy, MD

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The allocation sequence was concealed using sealed opaque envelopes . Patients and the operators were masked to the allocation of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 2 groups

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 20, 2025
• Study Start: December 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-01

Locations

EG (1)