Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries

Assiut University

Status: Not yet enrolling

Conditions: Cardiac Valve Disease

Treatments: Drug: Intrathecal morphine or dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06076759

Intrathecal analgesia

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Intrathecal morphine group (Group M):

Active Comparator group

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.

Treatment:

Drug: Intrathecal morphine or dexmedetomidine

Intrathecal dexmedetomidine group (Group D):

Active Comparator group

Description:

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

Treatment:

Drug: Intrathecal morphine or dexmedetomidine