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

NCT06369103 | Recruiting Phase 4

• 1 other identifier: FMBSUREC/03032024/Fakhry
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient; Satisfaction

Keywords

Sedative Effects; Dexmedetomidine; Propofol; Vitrectomy

Outcome Measures

Primary Outcomes (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.

  6 hours after the end of surgery.

Secondary Outcomes (1)

• Visual analogue scale

  6 hours after the end of surgery

Study Arms (2)

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.

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.

Drug: Propofol

Interventions

Dexmedetomidine 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.

Dexmedetomidine Group

Propofol 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.

Propofol Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 62814, Egypt

RECRUITING

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Dina M Fakhry, MD

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina M Fakhry, MD

CONTACT

+201289998680; dina_fakhry_91@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 16, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

EG (1)