Dexmedetomidine Versus Dexamethasone as an Additive to Local Anesthetic Mixture in Peribulbar Block in Cataract Surgeries

This study aimed to compare the effects of dexamethasone and dexmedetomidine when added to a local anesthetic mixture for peribulbar block in patients undergoing elective anterior segment eye surgery.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Dexamethasone; Local Anesthetic; Peribulbar Block; Cataract Surgeries
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Dexamethasone; Drug: Normal saline

Detailed Description

Regional block (especially peribulbar block) is the preferred choice of anesthesia for many ophthalmic surgeries as it has less complications. Peribulbar block with local anesthetics only lead to delayed onset corneal anesthesia and globe akinesia, and frequent need of block supplementation.

Dexmedetomidine is a drug which belongs to alpha 2 adrenergic receptor agonist. It provides several desirable effects, including sedation, anxiolysis, analgesia, and a reduction in intraoperative opioid requirements, when used as an adjuvant to local anesthetics, dexmedetomidine has been shown to prolong the duration of sensory and motor blocks, improve hemodynamic stability, and enhance overall patient satisfaction.

Dexamethasone, a synthetic corticosteroid, the use of dexamethasone as an additive in peribulbar blocks has been shown to improve the quality of anesthesia, reduce the need for supplemental intraoperative analgesics, and decrease postoperative pain.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Helwan, Egypt, 11795
    • Helwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: > 18 years old.
• Sex: Male & Female
• American Society of Anesthesiologists (ASA) Physical status I -III.
• Patients undergoing ophthalmic surgery under local anesthesia.

Exclusion Criteria:

• Patients' refusal.
• Patients have active ocular infection.
• Patients have single eyes.
• Allergy to thesis medications (mainly bupivacaine and lidocaine).
• Patients cannot lie flat.
• Patient on anticoagulation.
• Abnormal coagulation profile in the form of international normalized ratio (INR) ≥1.6

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients received 20 μg of dexmedetomidine in 1 ml solution.	Drug: Dexmedetomidine; Patients received 20 μg of dexmedetomidine in 1 ml solution.
Experimental: Group B; Patients received 4 mg dexamethasone in 1 ml solution.	Drug: Dexamethasone; Patients received 4 mg dexamethasone in 1 ml solution.
Active Comparator: Group C; Patients received 1 ml normal saline.	Drug: Normal saline; Patients received 1 ml normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for first request of the rescue analgesia	Time for first request of the rescue analgesia was recorded from the end of surgery till first dose of morphine administrated.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of patient satisfaction	Degree of patient satisfaction was assessed on a 4-point scale (1, excellent; 2, good; 3, fair; 4, poor).	24 hours postoperatively
Postoperative opioid consumption	If the Visual analogue score (VAS) was >4, a 0.1 mg/kg bolus dose of intravenous morphine will be administered if no response the bolus dose will be repeated with a maximum dose of 10 mg.	12 hours postoperatively
Degree of pain	Each patient was instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS was recorded , 2, 4, 8, and 12 hours postoperatively.	12 hours postoperatively
Heart rate	Heart rate was measured before and after the peribulbar injection (baseline) (5,10, 15, 30, 45, 60, 90 till 120 min) the each 6 hours for 12 hours postoperatively.	12 hours postoperatively
Mean arterial blood pressure	Mean arterial blood pressure was measured before and after the peribulbar injection (baseline) (5,10, 15, 30, 45, 60, 90 till 120 min) the each 6 hours for 12 hours postoperatively.	12 hours postoperatively
Intraocular pressure	Intraocular pressure (IOP) was measured 30 min before injection of the local anesthetics as a baseline reading. The other reading 10 min after injection of local anesthetics.	10 min after injection of local anesthetics

Collaborators and Investigators

• Sponsor: Helwan University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Azoles; Polycyclic Compounds; Imidazoles; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pregnadienetriols; Dexamethasone; Dexmedetomidine; Saline Solution
• Other Study ID Numbers: 131-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No