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NCT Number: NCT07675616

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

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) .

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Key information

Conditions

Hemodynamic Effect Dacryocystorhinostomy Dexmedetomidine General Anesthesia Lidocaine Magnesium Sulphate Peribulbar Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine + Dexmedetomidine

Drug

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

Lidocaine + Magnesium sulphate

Drug

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

Lidocaine

Drug

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

Primary outcomes

  1. Change in mean arterial blood pressure

    Time frame: Till the end of surgery (Up to 2 hours)

    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.

Secondary outcomes

  1. Heart rate

    Time frame: Till the end of surgery (Up to 2 hours)

    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.

  2. Oxygen saturation

    Time frame: Till the end of surgery (Up to 2 hours)

    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.

  3. Degree of patient satisfaction

    Time frame: 24 hours postoperatively

    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)

  4. Degree of surgeon satisfaction

    Time frame: 24 hours postoperatively

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Hebatullah S Abdelhamid, MD

CONTACT

[email protected]

00201044512277

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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