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Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries

Primary Purpose

Cardiac Valve Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intrathecal morphine or dexmedetomidine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Valve Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Cardiac patient scheduled for elective open heart valve replacement surgery. Exclusion Criteria: • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Intrathecal morphine group (Group M):

    Intrathecal dexmedetomidine group (Group D):

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Diaphragmatic function
    Chest ultrasonography for diaphragmatic function by measuring two parameters one is the diaphragmatic thickness and the other is diaphragmatic excursion at its largest echo, on both sides right and left, and by the same operator at three different settings, first is preoperative, second at time of spontaneous breathing trial postoperatively, and the last one is post extubation by 6 hours, and compare results to assess any diaphragmatic dysfunction even the subclinical one.

    Full Information

    First Posted
    September 29, 2023
    Last Updated
    October 8, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06076759
    Brief Title
    Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries
    Official Title
    Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries: Effect on Postoperative Pain and Diaphragmatic Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Comparison between the effects of intrathecal morphine versus intrathecal dexmedetomidine on analgesia and respiratory function, in open heart surgery.
    Detailed Description
    Postoperative pulmonary dysfunction is a well-recognized complication of open-heart surgeries. About 25% of patients who don't present with any severe impaired cardiac function reported to have significant pulmonary dysfunction for at least one week after operation. Many mechanisms could be accused of this dysfunction as respiratory mechanics failure by diaphragmatic paresis or paralysis, pain and muscle guarding, lung atelectasis, drains discomfort, etc. although pain is the major concern of patients, but sometimes it may not get the proper attention, pain in open heart surgery origins mainly from the surgical incision which is here a median sternotomy the most commonly used approach and the easiest access to the heart region, however median sternotomy may significantly impedes the pulmonary function by the resultant pain of this procedure and cause morbidity and mortality by itself

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Valve Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intrathecal morphine group (Group M):
    Arm Type
    Active Comparator
    Arm Description
    • Patients in this group will receive intrathecal morphine (0.5 mg diluted in I ml of normal saline) prior to induction of general anesthesia.
    Arm Title
    Intrathecal dexmedetomidine group (Group D):
    Arm Type
    Active Comparator
    Arm Description
    • Patients in this group will receive intrathecal dexmedetomidine (5 mcg diluted in 1 ml of normal saline) prior to induction of general anesthesia.
    Intervention Type
    Drug
    Intervention Name(s)
    Intrathecal morphine or dexmedetomidine
    Other Intervention Name(s)
    Morphine or dexmedetomidine
    Intervention Description
    Intrathecal injection
    Primary Outcome Measure Information:
    Title
    Total opioids consumption.
    Description
    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.
    Time Frame
    First 24 hour postoperatively
    Secondary Outcome Measure Information:
    Title
    Diaphragmatic function
    Description
    Chest ultrasonography for diaphragmatic function by measuring two parameters one is the diaphragmatic thickness and the other is diaphragmatic excursion at its largest echo, on both sides right and left, and by the same operator at three different settings, first is preoperative, second at time of spontaneous breathing trial postoperatively, and the last one is post extubation by 6 hours, and compare results to assess any diaphragmatic dysfunction even the subclinical one.
    Time Frame
    First 24 hour postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Cardiac patient scheduled for elective open heart valve replacement surgery. Exclusion Criteria: • 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sara Rabie
    Phone
    01009732361
    Email
    sararabie1991@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hany Moustafa
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries

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