Hemodynamic Effect of Dexmedetomidine Versus Magnesium Sulphate as an Adjuvant to Lidocaine in Preemptive Peribulbar Block in Patients Undergoing Dacryocystorhinostomy Under General Anesthesia

Hemodynamic Effect of Dexmedetomidine Versus Magnesium Sulphate as an Adjuvant to Lidocaine in Preemptive Peribulbar Block in Patients Undergoing Dacryocystorhinostomy Under General Anesthesia: A Randomized Controlled Trial

This study aims to compare the hemodynamic effect of dexmedetomidine and magnesium sulphate as an adjuvant to lidocaine in preemptive peribulbar block in patients undergoing Dacryocystorhinostomy (DCR) under general anaesthesia (GA) .

Study Overview

• Status: Recruiting
• Conditions: General Anesthesia; Dexmedetomidine; Lidocaine; Dacryocystorhinostomy; Magnesium Sulphate; Peribulbar Block; Hemodynamic Effect
• Intervention / Treatment: Drug: Lidocaine + Dexmedetomidine; Drug: Lidocaine + Magnesium sulphate; Drug: Lidocaine

Detailed Description

Dacryocystorhinostomy (DCR) is a delicate ophthalmic surgical procedure aimed at reestablishing the patency of the nasolacrimal duct in patients suffering from nasolacrimal duct obstruction (NLDO).

Magnesium is a non-competitive N-methyl-D-aspartate (NMDA) receptors antagonist, and it can decrease the excitatory post synaptic currents produced by activation of NMDA receptors and it inhibits voltage gated calcium channels.

Dexmedetomidine alpha-2 agonist, which stimulates both central and peripheral alpha-2 receptors which inhibits neuronal firing and inhibits release of C-fibers transmitters such as norepinephrine which inhibits nerve fiber action potential and explains the antinociceptive effects of dexmedetomidine.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hebatullah S Abdelhamid, MD; Phone Number: 00201044512277; Email: drhebasalah593@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Recruiting
    • Cairo University
    • Contact: Hebatullah S Abdelhamid, MD; Phone Number: 00201044512277; Email: drhebasalah593@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I or II.
• Undergoing elective Dacryocystorhinostomy (DCR) surgery under general anesthesia.

Exclusion Criteria:

• Patients have local infection.
• Allergic reaction or complications of the local anaesthesia (LA).
• Coagulopathy defined as international normalized ratio (INR) > 1.5, platelet count < 100,000/mm³, or ongoing anticoagulant therapy not adequately discontinued.
• Uncontrolled systemic disease, defined as poorly controlled hypertension [systolic blood pressure (SBP) > 160 mmHg], uncontrolled diabetes mellitus (HbA1c > 8.5%), unstable ischemic heart disease, or decompensated hepatic or renal disease.
• Uncooperative patients.

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 will receive 5 ml of lidocaine 2% + 50 µg dexmedetomidine, with a total volume of 7 ml.	Drug: Lidocaine + Dexmedetomidine; Patients will receive 5 ml of lidocaine 2% + 50 µg dexmedetomidine, with a total volume of 7 ml.
Experimental: Group B; Patients will receive 5 ml of lidocaine 2% + 100 mg magnesium sulphate 10%, with a total volume of 7 ml.	Drug: Lidocaine + Magnesium sulphate; Patients will receive 5 ml of lidocaine 2% + 100 mg magnesium sulphate 10%, with a total volume of 7 ml.
Active Comparator: Group C; Patients will receive 7 ml of lidocaine 2% with no further additives.	Drug: Lidocaine; Patients will receive 7 ml of lidocaine 2% with no further additives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean arterial blood pressure	The change in mean arterial blood pressure will be recorded at baseline, after induction of anesthesia, immediately before peribulbar block, after block administration, at skin incision, during osteotomy and lacrimal sac manipulation (oculocardiac reflexes-provoking steps), and every 5 minutes thereafter until the end of surgery.	Till the end of surgery (Up to 2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of patient satisfaction	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)	24 hours postoperatively
Heart rate	Heart rate will be recorded at baseline, after induction of anesthesia, immediately before peribulbar block, after block administration, at skin incision, during osteotomy and lacrimal sac manipulation (oculocardiac reflexes-provoking steps), and every 5 minutes thereafter until the end of surgery.	Till the end of surgery (Up to 2 hours)
Oxygen saturation	Oxygen saturation will be recorded at baseline, after induction of anesthesia, immediately before peribulbar block, after block administration, at skin incision, during osteotomy and lacrimal sac manipulation (oculocardiac reflexes-provoking steps), and every 5 minutes thereafter until the end of surgery.	Till the end of surgery (Up to 2 hours)
Degree of surgeon satisfaction	Degree of surgeon satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 27, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 27, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Inorganic Chemicals; Sulfur Acids; Sulfates; Sulfuric Acids; Magnesium Compounds; Lidocaine; Dexmedetomidine; Magnesium Sulfate
• Other Study ID Numbers: MS-141-2026 (14-5-2026)

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