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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this 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) .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Both sexes.

American Society of Anesthesiologists (ASA) physical status I or II.

Undergoing elective Dacryocystorhinostomy (DCR) surgery under general anesthesia.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

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

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.

Time frame
Till the end of surgery (Up to 2 hours)
3

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)

Time frame
24 hours postoperatively
4

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)

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.