Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Valve Disease
• Intervention / Treatment: Drug: Intrathecal morphine or dexmedetomidine

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Rabie; Phone Number: 01009732361; Email: sararabie1991@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Intrathecal morphine or dexmedetomidine; Intrathecal injection; Other Names: Morphine or dexmedetomidine
Active Comparator: 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.	Drug: Intrathecal morphine or dexmedetomidine; Intrathecal injection; Other Names: Morphine or dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hany Moustafa, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: September 29, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Dexmedetomidine; Morphine
• Other Study ID Numbers: Intrathecal analgesia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No