DexmedetomidineNCT07671066
Dexmedetomidine Versus Dexamethasone as an Additive to Local Anesthetic Mixture in Peribulbar Block in Cataract Surgeries
A study testing Dexmedetomidine, Dexamethasone and Normal saline in people with Dexmedetomidine and Dexamethasone, run by Helwan University at 1 site in Egypt.
Trial summary
This study aimed to compare the effects of dexamethasone and dexmedetomidine when added to a local anesthetic mixture for peribulbar block in patients undergoing elective anterior segment eye surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dexmedetomidine, Dexamethasone, Local Anesthetic
- What is being tested?
- Dexmedetomidine, Dexamethasone and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 old.
- Sex: Male \& Female
- American Society of Anesthesiologists (ASA) Physical status I -III.
- Patients undergoing ophthalmic surgery under local anesthesia.
Who cannot join
- Patients' refusal.
- Patients have active ocular infection.
- Patients have single eyes.
- Allergy to thesis medications (mainly bupivacaine and lidocaine).
- Patients cannot lie flat.
- Patient on anticoagulation.
- Abnormal coagulation profile in the form of international normalized ratio (INR) ≥1.6
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to compare the effects of dexamethasone and dexmedetomidine when added to a local anesthetic mixture for peribulbar block in patients undergoing elective anterior segment eye surgery.
Read the detailed description
Regional block (especially peribulbar block) is the preferred choice of anesthesia for many ophthalmic surgeries as it has less complications. Peribulbar block with local anesthetics only lead to delayed onset corneal anesthesia and globe akinesia, and frequent need of block supplementation.
Dexmedetomidine is a drug which belongs to alpha 2 adrenergic receptor agonist. It provides several desirable effects, including sedation, anxiolysis, analgesia, and a reduction in intraoperative opioid requirements, when used as an adjuvant to local anesthetics, dexmedetomidine has been shown to prolong the duration of sensory and motor blocks, improve hemodynamic stability, and enhance overall patient satisfaction.
Dexamethasone, a synthetic corticosteroid, the use of dexamethasone as an additive in peribulbar blocks has been shown to improve the quality of anesthesia, reduce the need for supplemental intraoperative analgesics, and decrease postoperative pain.
- Being tested
- Dexmedetomidine, Dexamethasone, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients received 20 μg of dexmedetomidine in 1 ml solution.
DexamethasoneDrug
Patients received 4 mg dexamethasone in 1 ml solution.
Normal salineDrug
Patients received 1 ml normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients received 20 μg of dexmedetomidine in 1 ml solution. Receives: Drug: Dexmedetomidine |
| Group B | Experimental | Patients received 4 mg dexamethasone in 1 ml solution. Receives: Drug: Dexamethasone |
| Group C | Active comparator | Patients received 1 ml normal saline. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for first request of the rescue analgesia
Time for first request of the rescue analgesia was recorded from the end of surgery till first dose of morphine administrated.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Postoperative opioid consumption
If the Visual analogue score (VAS) was >4, a 0.1 mg/kg bolus dose of intravenous morphine will be administered if no response the bolus dose will be repeated with a maximum dose of 10 mg.
Measured: 12 hours postoperatively
Degree of patient satisfaction
Degree of patient satisfaction was assessed on a 4-point scale (1, excellent; 2, good; 3, fair; 4, poor).
Measured: 24 hours postoperatively
Degree of pain
Each patient was instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS was recorded , 2, 4, 8, and 12 hours postoperatively.
Measured: 12 hours postoperatively
Heart rate
Heart rate was measured before and after the peribulbar injection (baseline) (5,10, 15, 30, 45, 60, 90 till 120 min) the each 6 hours for 12 hours postoperatively.
Measured: 12 hours postoperatively
Mean arterial blood pressure
Mean arterial blood pressure was measured before and after the peribulbar injection (baseline) (5,10, 15, 30, 45, 60, 90 till 120 min) the each 6 hours for 12 hours postoperatively.
Measured: 12 hours postoperatively
Intraocular pressure
Intraocular pressure (IOP) was measured 30 min before injection of the local anesthetics as a baseline reading. The other reading 10 min after injection of local anesthetics.
Measured: 10 min after injection of local anesthetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Dec 2024
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Ashraf Mandouh, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671066
- Sponsor's protocol ID
- 131-2024
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Dexamethasone as an Additive to Local Anesthetic Mixture in Peribulbar Block in Cataract Surgeries
- ClinicalTrials.gov ID
- NCT07671066
- Acronym / sponsor ID
- 131-2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 26 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 aimed to compare the effects of dexamethasone and dexmedetomidine when added to a local anesthetic mixture for peribulbar block in patients undergoing elective anterior segment eye surgery.
Detailed description
Regional block (especially peribulbar block) is the preferred choice of anesthesia for many ophthalmic surgeries as it has less complications. Peribulbar block with local anesthetics only lead to delayed onset corneal anesthesia and globe akinesia, and frequent need of block supplementation.
Dexmedetomidine is a drug which belongs to alpha 2 adrenergic receptor agonist. It provides several desirable effects, including sedation, anxiolysis, analgesia, and a reduction in intraoperative opioid requirements, when used as an adjuvant to local anesthetics, dexmedetomidine has been shown to prolong the duration of sensory and motor blocks, improve hemodynamic stability, and enhance overall patient satisfaction.
Dexamethasone, a synthetic corticosteroid, the use of dexamethasone as an additive in peribulbar blocks has been shown to improve the quality of anesthesia, reduce the need for supplemental intraoperative analgesics, and decrease postoperative pain.
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: DexmedetomidinePatients received 20 μg of dexmedetomidine in 1 ml solution. |
| Group B | Experimental | Drug: DexamethasonePatients received 4 mg dexamethasone in 1 ml solution. |
| Group C | Active comparator | Drug: Normal salinePatients received 1 ml normal saline. |
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 old.
- Sex: Male \& Female
- American Society of Anesthesiologists (ASA) Physical status I -III.
- Patients undergoing ophthalmic surgery under local anesthesia.
Key exclusion criteria (7 listed)
- Patients' refusal.
- Patients have active ocular infection.
- Patients have single eyes.
- Allergy to thesis medications (mainly bupivacaine and lidocaine).
- Patients cannot lie flat.
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 |
|---|---|---|
| DexmedetomidinePatients received 20 μg of dexmedetomidine in 1 ml solution. | Drug | Group A |
| DexamethasonePatients received 4 mg dexamethasone in 1 ml solution. | Drug | Group B |
| Normal salinePatients received 1 ml normal saline. | Drug | Group C |
Primary outcome
Time for first request of the rescue analgesia
Time frame: 24 hours postoperatively
Time for first request of the rescue analgesia was recorded from the end of surgery till first dose of morphine administrated.
6 secondary outcomes
Postoperative opioid consumption
Time frame: 12 hours postoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 12 hours postoperatively
Heart rate
Time frame: 12 hours postoperatively
Mean arterial blood pressure
Time frame: 12 hours postoperatively
Intraocular pressure
Time frame: 10 min after injection of local anesthetics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Dexamethasone and Normal saline in people with Dexmedetomidine and Dexamethasone, run by Helwan 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 7 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: finished, as of the sponsor's last update on 26 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for first request of the rescue analgesia (time frame: 24 hours postoperatively). 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 26 Jun 2026.