Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries

Cardiac Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06076759
• Other study ID #: Intrathecal analgesia
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Sara Rabie
• Phone: 01009732361
• Email: sararabie1991[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Valve Disease
• Heart Valve Diseases

Intervention

Drug:
• Intrathecal morphine or dexmedetomidine
Intrathecal injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	First 24 hour postoperatively