Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries

NCT06076759 | Unknown

• 1 other identifier: Intrathecal analgesia
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison between the effects of intrathecal morphine versus intrathecal dexmedetomidine on analgesia and respiratory function, in open heart surgery.

Conditions

Cardiac Valve Disease

Outcome Measures

Primary Outcomes (1)

• Total opioids consumption.

  Pain would be assessed subjectively by the patient using the numerical scale from 0 to 10 by the and boluses of fentanyl 1 mic/kg would be given when requested by the patient, then the total fentanyl consumption during the first 24h post operative would be calculated.

  First 24 hour postoperatively

Secondary Outcomes (1)

• Diaphragmatic function

  First 24 hour postoperatively

Study Arms (2)

Intrathecal morphine group (Group M):

ACTIVE COMPARATOR

• Patients in this group will receive intrathecal morphine (0.5 mg diluted in I ml of normal saline) prior to induction of general anesthesia.

Drug: Intrathecal morphine or dexmedetomidine

Intrathecal dexmedetomidine group (Group D):

ACTIVE COMPARATOR

• Patients in this group will receive intrathecal dexmedetomidine (5 mcg diluted in 1 ml of normal saline) prior to induction of general anesthesia.

Drug: Intrathecal morphine or dexmedetomidine

Interventions

Intrathecal morphine or dexmedetomidine DRUG

Intrathecal injection

Also known as: Morphine or dexmedetomidine

Intrathecal dexmedetomidine group (Group D):; Intrathecal morphine group (Group M):

Eligibility Criteria

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

You may qualify if:

• \- Cardiac patient scheduled for elective open heart valve replacement surgery.

You may not qualify if:

• Patient refusal
• Coagulation disorders
• History of known allergy to the used drugs.
• Combined procedures (e.gif combined with coronary artery bypass or aortic root surgeries).
• If thoracotomy or min-sternotomy is planned for the surgery.
• Re-do and emergency surgeries.
• History of chronic chest diseases (COPD or IPF).
• History of thoracotomy, pneumothorax, pneumomediastinum, phrenic nerve injury (as evident by the presence of paralysis of the ipsilateral hemidiaphragm when examined preoperatively).
• Neuromuscular diseases.
• Brain injuries.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Dexmedetomidine; Morphine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Hany Moustafa

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Rabie

CONTACT

01009732361; sararabie1991@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 11, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10