Dexmedetomidine Versus Midazolam for Peribulbar Block

NCT ID: NCT06784843

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-09-30

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

peribulbar block 1

Patients who were scheduled for cataract surgery under peribulbar block.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block

Intervention Type: DRUG

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

peribulbar block 2

Patients who were scheduled for cataract surgery under peribulbar block.

Group Type: ACTIVE_COMPARATOR

Midazolam as an adjuvant to local anesthesia for peribulbar block

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

DEX; MID

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrhman Alshawadfy

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdelrhman Alshawadfy, MD

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University

Locations

Suez canal university

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

peribulbar block

Identifier Type: -

Identifier Source: org_study_id