Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries

Not Applicable

Not yet recruiting

• Conditions: Cardiac Valve Disease
• Interventions: Drug: Intrathecal morphine or dexmedetomidine

• Registration Number: NCT06076759
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2023-09-29
• Status Verified: 2023-10
• Study Start: 2023-10-01
• Study First Submitted QC: 2023-10-08
• Last Update Submitted: 2023-10-08
• Study First Posted: 2023-10-11
• Last Update Posted: 2023-10-11
• Primary Completion: 2024-10-01
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal morphine group (Group M):	Intrathecal morphine or dexmedetomidine	• Patients in this group will receive intrathecal morphine (0.5 mg diluted in I ml of normal saline) prior to induction of general anesthesia.
Intrathecal dexmedetomidine group (Group D):	Intrathecal morphine or dexmedetomidine	• Patients in this group will receive intrathecal dexmedetomidine (5 mcg diluted in 1 ml of normal saline) prior to induction of general anesthesia.

Primary Outcome Measures

Name	Time	Method
Total opioids consumption.	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 Outcome Measures

Name	Time	Method
Diaphragmatic function	First 24 hour postoperatively	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.