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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Dina M Fakhry, MD contact

+201289998680

dina_fakhry_91@yahoo.com

Egypt1 site, 1 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

    Recruiting

Other trials in Egypt

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.

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 groups in NCT06369103
Study groupRoleWhat they receive
Dexmedetomidine GroupActive comparatorPatients 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 GroupActive comparatorPatients 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.

  1. 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)
  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.

  1. First posted16 Apr 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 May 2025 (estimated)

Resources

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)
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

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.

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