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

NCT07675616 | Recruiting

• 1 other identifier: MS-141-2026 (14-5-2026)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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) .

Conditions

Hemodynamic Effect; Dexmedetomidine; Magnesium Sulphate; Lidocaine; Peribulbar Block; Dacryocystorhinostomy; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Heart rate

  Till the end of surgery (Up to 2 hours)

• Oxygen saturation

  Till the end of surgery (Up to 2 hours)

• Degree of patient satisfaction

  24 hours postoperatively

• Degree of surgeon satisfaction

  24 hours postoperatively

Study Arms (3)

Group A

EXPERIMENTAL

Patients will receive 5 ml of lidocaine 2% + 50 µg dexmedetomidine, with a total volume of 7 ml.

Drug: Lidocaine + Dexmedetomidine

Group B

EXPERIMENTAL

Patients will receive 5 ml of lidocaine 2% + 100 mg magnesium sulphate 10%, with a total volume of 7 ml.

Drug: Lidocaine + Magnesium sulphate

Group C

ACTIVE COMPARATOR

Patients will receive 7 ml of lidocaine 2% with no further additives.

Drug: Lidocaine

Interventions

Lidocaine + Dexmedetomidine DRUG

Patients will receive 5 ml of lidocaine 2% + 50 µg dexmedetomidine, with a total volume of 7 ml.

Group A

Lidocaine + Magnesium sulphate DRUG

Patients will receive 5 ml of lidocaine 2% + 100 mg magnesium sulphate 10%, with a total volume of 7 ml.

Group B

Lidocaine DRUG

Patients will receive 7 ml of lidocaine 2% with no further additives.

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Lidocaine; Dexmedetomidine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Hebatullah S Abdelhamid, MD

CONTACT

00201044512277; drhebasalah593@gmail.com

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: Lecturer of Anesthesia, Surgical Critical Care and Pain Management Department, Faculty of Medicine, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 30, 2026
• Study Start: May 16, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 30, 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)