PatientPhase 4NCT06369103
The Sedative Effects of Dexmedetomidine VS Propofol During Peribulbar Anesthesia in Patients Undergoing Vitrectomy Surgery
A Phase 4 study testing Dexmedetomidine and Propofol in people with Patient and Satisfaction, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of the work to compare the Sedative Effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery on hemodynamic, respiratory parameters, recovery profile, analgesic effects, post-operative cognitive function, patients satisfaction and adverse events. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Patient, Satisfaction
- What is being tested?
- Dexmedetomidine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 May 2025
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-70 years.
- Expected time of surgery less than 2 hours
Who cannot join
- patients with an initial mini mental state examination (MMSE) score less than 23
- Patients refusing LA
- Clotting abnormalities
- Impaired mental status
- Allergy to any of the study medications
- Also, patients were excluded if they had severe cardiac disease, chronic obstructive lung disease, a history of sleep apnea and those who received general anesthesia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni Suef University Hospital
Banī Suwayf, Beni Suweif Governorate, 62814
Dina M Fakhry, MD, 0201289998680, dina_fakhry_91@yahoo.com
Dina M Fakhry, MD, +201289998680, dina_fakhry_91@yahoo.com
About this study
Official title: Comparison of the Sedative Effects of Dexmedetomidine and Propofol During Peribulbar Anaesthesia in Patients Undergoing Vitrectomy Surgery: A Prospective Randomized Clinical Trial
The aim of the work to compare the Sedative Effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery on hemodynamic, respiratory parameters, recovery profile, analgesic effects, post-operative cognitive function, patients satisfaction and adverse events.
Read the detailed description
In ocular surgery, local anesthesia or regional anesthesia is generally preferred over general anesthesia because of quicker patient rehabilitation and the avoidance of possible complications from general anesthesia. However, even with these anesthesia techniques, pain, fear and anxiety are major predictors of lower patient satisfaction.
Vitrectomy surgery is one of the most common outpatient ophthalmic surgeries. It can be performed with peribulbar anesthesia and intravenous (IV) sedation support, allowing the procedure to be completed in most patients without the need for general anesthesia. Vitrectomy surgery is a painful and lengthy procedure; therefore, sedation is applied to reduce patient agitation, ensuring both surgical comfort and hemodynamic stability. However, various complications can arise during the perioperative period depending on the sedation agent used.
Intravenous sedation is frequently used during ophthalmic regional anesthesia. There is no 'ideal' drug for sedation or analgesia. Various drugs either alone or in combination have been used with different methods of administration. The preferred sedative agent for ophthalmic surgeries performed under local anesthesia should have rapid onset but a short duration of action to ensure rapid recovery. It should be non-accumulating, non-toxic and have a favorable therapeutic index with minimal side effects. Unfortunately no drug is presently available that fulfils all these criteria. The available sedative drugs are benzodiazepines, intravenous anaesthetic induction agents (e.g. propofol), opiates and α-adrenoreceptor agonists such as dexmedetomidine or clonidine.
Among anesthetic agents, Dexmedetomidine is a strong selective α2-adrenergic agonist with sympatholytic, anxiolytic, analgesic and dose-dependent sedative/hypnotic properties, without causing respiratory depression.
Moreover, the use of dexmedetomidine reduces anesthetic and opioid requirements and also psychomotor function to be reserved.
Dexmedetomidine is the preferred agent for sedation in retinal surgery because of its ability to maintain hemodynamic and respiratory stability.
On the other hand, Propofol is an important intravenous anesthetic agent that has been extensively used as a sedative agent for ophthalmic procedures due to its favorable pharmacokinetic properties. Propofol has short duration of action, no cumulative effect, unique recovery profile as well as rapid emergence and anti-emetic properties. Respiratory depression and reduced blood pressure are major side effects of propofol. However, it has been suggested that propofol may still be safely administered if given at a lower dose. Other side effects of propofol include pain on injection, increased oculocardiac reflex, anaphylaxis and patient movement.
Despite many benefits, propofol sedation has been involved in producing the photic sneezing reflex induced by periocular injections of anesthetics.
Unexpected or sudden sneezing during injection can be a dangerous side effect in periocular injection, in which abrupt head movement may cause globe injury.
- Conditions
- Patient, Satisfaction
- Being tested
- Dexmedetomidine, Propofol
- Keywords
- Sedative Effects, Dexmedetomidine, Propofol, Vitrectomy
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients will receive dexmedetomidine at a dose of 0.5-1.0 mcg/kg over 5-10 minutes, then a maintenance infusion rate of 0.2-0.5 mcg/kg/min when the bispectral index (BIS) value is between 70 and 80.
PropofolDrug
Patients will receive propofol at a dose of 0.25-0.5 mg/kg over 5-10 minutes, then a maintenance Infusion rate of 0.5-2 mg/kg/hr when the bispectral index (BIS) value is between 70 and 80.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Patients will receive dexmedetomidine at a dose of 0.5-1.0 mcg/kg over 5-10 minutes, then a maintenance infusion rate of 0.2-0.5 mcg/kg/min when the bispectral index (BIS) value is between 70 and 80. Receives: Drug: Dexmedetomidine |
| Propofol Group | Active comparator | Patients will receive propofol at a dose of 0.25-0.5 mg/kg over 5-10 minutes, then a maintenance Infusion rate of 0.5-2 mg/kg/hr when the bispectral index (BIS) value is between 70 and 80. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction will be also assessed using 7-point Likert-like verbal rating scale. One means extremely dissatisfied and seven means extremely satisfied.
Measured: 6 hours after the end of surgery.
Secondary outcomes (1)
Visual analogue scale
The degree of pain was assessed by using a 10-cm visual analog scale (VAS) for pain where: 0=no pain and 10=intolerable pain
Measured: 6 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PatientStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mahmoud Fakhry, Beni-Suef University
- Investigators
- Dina M Fakhry, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369103
- Sponsor's protocol ID
- FMBSUREC/03032024/Fakhry
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Sedative Effects of Dexmedetomidine and Propofol During Peribulbar Anaesthesia in Patients Undergoing Vitrectomy Surgery: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06369103
- Acronym / sponsor ID
- FMBSUREC/03032024/Fakhry
- Conditions
- Patient, Satisfaction
- Keywords
- Sedative Effects, Dexmedetomidine, Propofol, Vitrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 16 Apr 2024 (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.
The aim of the work to compare the Sedative Effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery on hemodynamic, respiratory parameters, recovery profile, analgesic effects, post-operative cognitive function, patients satisfaction and adverse events.
Detailed description
In ocular surgery, local anesthesia or regional anesthesia is generally preferred over general anesthesia because of quicker patient rehabilitation and the avoidance of possible complications from general anesthesia. However, even with these anesthesia techniques, pain, fear and anxiety are major predictors of lower patient satisfaction.
Vitrectomy surgery is one of the most common outpatient ophthalmic surgeries. It can be performed with peribulbar anesthesia and intravenous (IV) sedation support, allowing the procedure to be completed in most patients without the need for general anesthesia. Vitrectomy surgery is a painful and lengthy procedure; therefore, sedation is applied to reduce patient agitation, ensuring both surgical comfort and hemodynamic stability. However, various complications can arise during the perioperative period depending on the sedation agent used.
Intravenous sedation is frequently used during ophthalmic regional anesthesia. There is no 'ideal' drug for sedation or analgesia. Various drugs either alone or in combination have been used with different methods of administration. The preferred sedative agent for ophthalmic surgeries performed under local anesthesia should have rapid onset but a short duration of action to ensure rapid recovery. It should be non-accumulating, non-toxic and have a favorable therapeutic index with minimal side effects. Unfortunately no drug is presently available that fulfils all these criteria. The available sedative drugs are benzodiazepines, intravenous anaesthetic induction agents (e.g. propofol), opiates and α-adrenoreceptor agonists such as dexmedetomidine or clonidine.
Among anesthetic agents, Dexmedetomidine is a strong selective α2-adrenergic agonist with sympatholytic, anxiolytic, analgesic and dose-dependent sedative/hypnotic properties, without causing respiratory depression.
Moreover, the use of dexmedetomidine reduces anesthetic and opioid requirements and also psychomotor function to be reserved.
Dexmedetomidine is the preferred agent for sedation in retinal surgery because of its ability to maintain hemodynamic and respiratory stability.
On the other hand, Propofol is an important intravenous anesthetic agent that has been extensively used as a sedative agent for ophthalmic procedures due to its favorable pharmacokinetic properties. Propofol has short duration of action, no cumulative effect, unique recovery profile as well as rapid emergence and anti-emetic properties. Respiratory depression and reduced blood pressure are major side effects of propofol. However, it has been suggested that propofol may still be safely administered if given at a lower dose. Other side effects of propofol include pain on injection, increased oculocardiac reflex, anaphylaxis and patient movement.
Despite many benefits, propofol sedation has been involved in producing the photic sneezing reflex induced by periocular injections of anesthetics.
Unexpected or sudden sneezing during injection can be a dangerous side effect in periocular injection, in which abrupt head movement may cause globe injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Drug: DexmedetomidinePatients will receive dexmedetomidine at a dose of 0.5-1.0 mcg/kg over 5-10 minutes, then a maintenance infusion rate of 0.2-0.5 mcg/kg/min when the bispectral index (BIS) value is between 70 and 80. |
| Propofol Group | Active comparator | Drug: PropofolPatients will receive propofol at a dose of 0.25-0.5 mg/kg over 5-10 minutes, then a maintenance Infusion rate of 0.5-2 mg/kg/hr when the bispectral index (BIS) value is between 70 and 80. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 20-70 years.
- Expected time of surgery less than 2 hours
Key exclusion criteria (6 listed)
- patients with an initial mini mental state examination (MMSE) score less than 23
- Patients refusing LA
- Clotting abnormalities
- Impaired mental status
- Allergy to any of the study medications
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 will receive dexmedetomidine at a dose of 0.5-1.0 mcg/kg over 5-10 minutes, then a maintenance infusion rate of 0.2-0.5 mcg/kg/min when the bispectral index (BIS) value is between 70 and 80. | Drug | Dexmedetomidine Group |
| PropofolPatients will receive propofol at a dose of 0.25-0.5 mg/kg over 5-10 minutes, then a maintenance Infusion rate of 0.5-2 mg/kg/hr when the bispectral index (BIS) value is between 70 and 80. | Drug | Propofol Group |
Primary outcome
Patient satisfaction
Time frame: 6 hours after the end of surgery.
Patient satisfaction will be also assessed using 7-point Likert-like verbal rating scale. One means extremely dissatisfied and seven means extremely satisfied.
1 secondary outcome
Visual analogue scale
Time frame: 6 hours after the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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.
Dina M Fakhry, MD principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Propofol in people with Patient and Satisfaction, run by Beni-Suef 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina M Fakhry, MD (+201289998680, dina_fakhry_91@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 6 hours after the end of surgery.). 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 16 Apr 2024.