Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries

NCT ID: NCT06076759

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-11-30

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

Conditions

Cardiac Valve Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Intrathecal morphine or dexmedetomidine

Intervention Type: DRUG

Intrathecal injection

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.

Group Type: ACTIVE_COMPARATOR

Intrathecal morphine or dexmedetomidine

Intervention Type: DRUG

Intrathecal injection

Interventions

Intrathecal morphine or dexmedetomidine

Intrathecal injection

Intervention Type: DRUG

Other Intervention Names

Morphine or dexmedetomidine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sara Usama Mohammed Rabie

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hany Moustafa

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Sara Rabie

Role: CONTACT

sararabie1991@gmail.com

01009732361

Other Identifiers

Intrathecal analgesia

Identifier Type: -

Identifier Source: org_study_id