Hemodynamic EffectNCT07675616
Hemodynamic Effect of Dexmedetomidine Versus Magnesium Sulphate as an Adjuvant to Lidocaine in Preemptive Peribulbar Block in Patients Undergoing Dacryocystorhinostomy Under General Anesthesia
A study testing Lidocaine + Dexmedetomidine, Lidocaine + Magnesium sulphate and Lidocaine in people with Hemodynamic Effect and Dexmedetomidine, run by Cairo University at 1 site in Egypt.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Effect, Dexmedetomidine, Magnesium Sulphate
- What is being tested?
- Lidocaine + Dexmedetomidine, Lidocaine + Magnesium sulphate and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 16 May 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Undergoing elective Dacryocystorhinostomy (DCR) surgery under general anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Hebatullah S Abdelhamid, MD, 00201044512277, drhebasalah593@gmail.com
About this study
Official 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
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) .
Read the 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.
- Conditions
- Hemodynamic Effect, Dexmedetomidine, Magnesium Sulphate, Lidocaine, Peribulbar Block, Dacryocystorhinostomy
- Being tested
- Lidocaine + Dexmedetomidine, Lidocaine + Magnesium sulphate, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine + DexmedetomidineDrug
Patients will receive 5 ml of lidocaine 2% + 50 µg dexmedetomidine, with a total volume of 7 ml.
Lidocaine + Magnesium sulphateDrug
Patients will receive 5 ml of lidocaine 2% + 100 mg magnesium sulphate 10%, with a total volume of 7 ml.
LidocaineDrug
Patients will receive 7 ml of lidocaine 2% with no further additives.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will receive 5 ml of lidocaine 2% + 50 µg dexmedetomidine, with a total volume of 7 ml. Receives: 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. Receives: Drug: Lidocaine + Magnesium sulphate |
| Group C | Active comparator | Patients will receive 7 ml of lidocaine 2% with no further additives. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Till the end of surgery (Up to 2 hours)
Secondary outcomes (4)
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.
Measured: 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.
Measured: Till the end of surgery (Up to 2 hours)
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)
Measured: 24 hours postoperatively
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)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start16 May 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic EffectStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah Salah Abdelhamid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675616
- Sponsor's protocol ID
- MS-141-2026 (14-5-2026)
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07675616
- Acronym / sponsor ID
- MS-141-2026 (14-5-2026)
- Conditions
- Hemodynamic Effect, Dexmedetomidine, Magnesium Sulphate, Lidocaine, Peribulbar Block, Dacryocystorhinostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 May 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Lidocaine + DexmedetomidinePatients will receive 5 ml of lidocaine 2% + 50 µg dexmedetomidine, with a total volume of 7 ml. |
| Group B | Experimental | Drug: Lidocaine + Magnesium sulphatePatients will receive 5 ml of lidocaine 2% + 100 mg magnesium sulphate 10%, with a total volume of 7 ml. |
| Group C | Active comparator | Drug: LidocainePatients will receive 7 ml of lidocaine 2% with no further additives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Undergoing elective Dacryocystorhinostomy (DCR) surgery under general anesthesia.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine + DexmedetomidinePatients will receive 5 ml of lidocaine 2% + 50 µg dexmedetomidine, with a total volume of 7 ml. | Drug | Group A |
| Lidocaine + Magnesium sulphatePatients will receive 5 ml of lidocaine 2% + 100 mg magnesium sulphate 10%, with a total volume of 7 ml. | Drug | Group B |
| LidocainePatients will receive 7 ml of lidocaine 2% with no further additives. | Drug | Group C |
Primary outcome
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.
4 secondary outcomes
Heart rate
Time frame: Till the end of surgery (Up to 2 hours)
Oxygen saturation
Time frame: Till the end of surgery (Up to 2 hours)
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Degree of surgeon satisfaction
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine + Dexmedetomidine, Lidocaine + Magnesium sulphate and Lidocaine in people with Hemodynamic Effect and Dexmedetomidine, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hebatullah S Abdelhamid, MD (00201044512277, drhebasalah593@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean arterial blood pressure (time frame: Till the end of surgery (Up to 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.