Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation

NCT06464263 | Recruiting DMC

• 1 other identifier: Anesth-._098/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative sedation is an essential component in recovery of the patient undergoing cardiac surgery. It facilitates the patient's unawareness of the environment as well as reduce the discomfort and anxiety caused by surgery, intubation, mechanical ventilation, suction, and physiotherapy. Despite the advances in anesthesia and surgical techniques, the duration of mechanical ventilation (MV) may be prolonged after cardiac surgery, due to the classic high-dose narcotic-based cardiac anesthesia.

Conditions

Valvular Cardiac Surgeries

Outcome Measures

Primary Outcomes (1)

• Pain Relieve

  Assessment of the pain post-operatively in patients with pain score by VAS as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain

  2 hours post operative

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

This Group about 30 patients will receive a loading dose of 1 μg/kg dexmedetomidine (Precedex 4 mcg/ml, Pfizer. Inc, New York, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2-0.7 μg/kg/h.

Drug: Dexmedetomidine

Fentanyl Group

EXPERIMENTAL

This Group about 30 patients will receive an initial bolus dose of fentanyl (fentanyl 50 mcg/ml, hameln; Netherlands) of 1-2 μg/kg, followed by an infusion at an initial rate of 1 to 2 μg/kg/h.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

to investigate the postoperative analgesic-sedative effect of dexmedetomidine versus fentanyl-midazolam to achieve fast-track extubation after adult valvular cardiac surgeries.

Also known as: fentanyl 50 mcg/ml

Dexmedetomidine Group; Fentanyl Group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- This study will include patients undergoing elective adult valvular cardiac surgeries

You may not qualify if:

• Patient refusal.
• Emergent valve cardiac surgeries.
• Patients with known hypersensitivity to study drugs.
• History of uncontrolled diabetes or hypertension.
• Impaired kidney or liver functions.
• Perioperative hemodynamic instability.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Al-Azhar University hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• Mohammed Ibrahim Mohammed Hashish, Professor

  Al-Azhar University, Faculty of medicine

  STUDY CHAIR

• Mohamed husseiny Mahmoud, Lecturer

  Cardio-Thoracic Surgery Department, Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Ramadan Ibrahim, MSC

CONTACT

+201002749797; 782014arar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 18, 2024
• Study Start: February 10, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 10, 2026
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

EG (1)