Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation

NCT ID: NCT06464263

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2026-02-10

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.

Detailed Description

In recent years, fast-track extubation (FTE) protocols have been developed to reduce the long period of intubation and complications that may occur due to the long duration of MV. Potential advantages of FTE protocols following surgery for congenital cardiac disease are reduced ventilator-associated pulmonary complications and the negative effects of positive pressure ventilation, reduced nosocomial infections, postoperative atelectasis, reduced requirements of sedatives and analgesic drugs, early enteral feeding, rapid patient mobilization, and shorter intensive care unit (ICU) stay.

The ideal analgesic-sedative agents would keep the patient comfortable without anxiety. It would effectively provide adequate sedation, but also allow neurologic evaluation of the patient, ideally without stopping administration of the drug. It would have minimal hemodynamic and respiratory depressant effects. It also would have a rapid onset and offset of action without drug accumulation or active metabolites, making it easily titratable and allowing rapid recovery with a prompt return to normal activity after discontinuation.

Opioids and benzodiazepines are the most frequently used analgesic-sedative agents after cardiac surgery. Although opioid can provide excellent analgesia, the doses for effective pain relief may lead to undesirable side effects, such as respiratory depression requiring prolonged MV, hemodynamic instability, tolerance, and significant withdrawal symptoms that also delay patient recovery.

Dexmedetomidine is a highly selective α2-adrenoreceptor agonist. Presynaptic activation of α2-adrenoreceptors at sympathetic nerve endings inhibits catecholamine release. The major effect of dexmedetomidine is maintaining sedation-analgesia without a respiratory depressant effect. It has relatively few cardiovascular side effects and produces sleep-like sedation without narcosis or respiratory depression.

Indeed, current guidelines recommend lighter levels of sedation to manage ventilated patients preferably using nonbenzodiazepine sedatives. Nevertheless, there is currently no consistent recommendation regarding which nonbenzodiazepine sedative agents should be used.

Conditions

Valvular Cardiac Surgeries

Study Design

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

Study Groups

Dexmedetomidine Group

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Fentanyl Group

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

Other Intervention Names

fentanyl 50 mcg/ml

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammed Ibrahim Mohammed Hashish, Professor

Role: STUDY_CHAIR

Al-Azhar University, Faculty of medicine

Mohamed husseiny Mahmoud, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Cardio-Thoracic Surgery Department, Al-Azhar University

Locations

Al-Azhar University hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Ramadan Ibrahim, MSC

Role: CONTACT

782014arar@gmail.com

+201002749797

Facility Contacts

Ahmed Ramadan Ibrahim, M.D

Role: primary

782014arar@gmail.com

+201002749797

Assist.Prof.

Role: backup

Other Identifiers

Anesth-._098/2023

Identifier Type: -

Identifier Source: org_study_id