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

NCT07671066 | Completed

• 1 other identifier: 131-2024
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dexmedetomidine; Dexamethasone; Local Anesthetic; Peribulbar Block; Cataract Surgeries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Postoperative opioid consumption

  12 hours postoperatively

• Degree of patient satisfaction

  24 hours postoperatively

• Degree of pain

  12 hours postoperatively

• Heart rate

  12 hours postoperatively

• Mean arterial blood pressure

  12 hours postoperatively

Study Arms (3)

Group A

EXPERIMENTAL

Patients received 20 μg of dexmedetomidine in 1 ml solution.

Drug: Dexmedetomidine

Group B

EXPERIMENTAL

Patients received 4 mg dexamethasone in 1 ml solution.

Drug: Dexamethasone

Group C

ACTIVE COMPARATOR

Patients received 1 ml normal saline.

Drug: Normal saline

Interventions

Dexmedetomidine DRUG

Patients received 20 μg of dexmedetomidine in 1 ml solution.

Group A

Dexamethasone DRUG

Patients received 4 mg dexamethasone in 1 ml solution.

Group B

Normal saline DRUG

Patients received 1 ml normal saline.

Group C

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University

Helwan, 11795, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Dexamethasone; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Helwan University, Egypt.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: December 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)