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Clinical Trials/NCT06076759
NCT06076759
Not yet recruiting
Not Applicable

Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries: Effect on Postoperative Pain and Diaphragmatic Function

Assiut University0 sites40 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Intrathecal morphine or dexmedetomidine
Conditions
Cardiac Valve Disease
Sponsor
Assiut University
Enrollment
40
Primary Endpoint
Total opioids consumption.
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
November 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sara Usama Mohammed Rabie

Principle investigator

Assiut University

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.

Arms & Interventions

Intrathecal morphine group (Group M):

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

Intervention: Intrathecal morphine or dexmedetomidine

Intrathecal dexmedetomidine group (Group D):

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

Intervention: Intrathecal morphine or dexmedetomidine

Outcomes

Primary Outcomes

Total opioids consumption.

Time Frame: First 24 hour postoperatively

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 Outcomes

  • Diaphragmatic function(First 24 hour postoperatively)

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