Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation

June 12, 2024 updated by: Egymedicalpedia

Comparative Study Between Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation After Adult Valvular Cardiac Surgeries; a Prospective Randomized Blinded Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Al-Azhar University Hospitals
        • Contact:
        • Contact:
          • Assist.Prof.
        • Principal Investigator:
          • Ismail Mohamed Abdelgawad, Assist.Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Dexmedetomidine
to investigate the postoperative analgesic-sedative effect of dexmedetomidine versus fentanyl-midazolam to achieve fast-track extubation after adult valvular cardiac surgeries.
Other Names:
  • fentanyl 50 mcg/ml
Experimental: 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.
Drug: Dexmedetomidine
to investigate the postoperative analgesic-sedative effect of dexmedetomidine versus fentanyl-midazolam to achieve fast-track extubation after adult valvular cardiac surgeries.
Other Names:
  • fentanyl 50 mcg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Relieve
Time Frame: 2 hours post operative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egymedicalpedia

Investigators

  • Study Chair: Mohammed Ibrahim Mohammed Hashish, Professor, Al-Azhar University, Faculty of Medicine
  • Principal Investigator: Mohamed husseiny Mahmoud, Lecturer, Cardio-Thoracic Surgery Department, Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 10, 2026

Study Registration Dates

First Submitted

June 9, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anesth-._098/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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