The Sedative Effects of Dexmedetomidine VS Propofol During Peribulbar Anesthesia in Patients Undergoing Vitrectomy Surgery

NCT ID: NCT06369103

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-05-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexmedetomidine Group

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.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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.

Propofol Group

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.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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.

Interventions

Dexmedetomidine

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.

Intervention Type: DRUG

Propofol

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age between 20-70 years.
• Expected time of surgery less than 2 hours

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Dina Mahmoud Fakhry

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina M Fakhry, MD

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

Beni Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina M Fakhry, MD

Role: CONTACT

dina_fakhry_91@yahoo.com

+201289998680

Facility Contacts

Dina M Fakhry, MD

Role: primary

dina_fakhry_91@yahoo.com

0201289998680

Dina M Fakhry, MD

Role: backup

dina_fakhry_91@yahoo.com

+201289998680

Other Identifiers

FMBSUREC/03032024/Fakhry

Identifier Type: -

Identifier Source: org_study_id