Dexmedetomidine for Pain Reduction in CABG

NCT05534230 | Unknown

• 1 other identifier: 2022-012-SJMO
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether adjuvant intravenous dexmedetomidine infusion starting after induction of general anesthesia can provide superior pain management (decrease pain scores) and decrease opioid administration, without increasing nausea/vomiting, compared to patients receiving only opioid and acetaminophen for the patients which going through coronary artery bypass grafting (CABG)?

Conditions

Analgesia

Keywords

Dexmedotimidine, CABG, Pain Management

Outcome Measures

Primary Outcomes (2)

• Visual analog pain (VAS) scores at 6, 12, 18, and 24 hours post-surgery

  Pain scores are measured by asking the patients to rank their pain from 1 to 10

  measured at 6, 12, 18, and 24 hours post-surgery

• Total opioid consumption in the first 24 hours after surgery (Oral morphine equivalents)

  the totalOral morphine equivalent dose of Opioids received by the patient 24 hour after the surgery is calculated

  24 Hours post surgery

Secondary Outcomes (11)

• Incidence of post-operation nausea and vomiting (PONV) (treatment with anti-emetic) in the first 24 hours

  24 Hours Post Surgery

• Incidence of pruritus (Percent of patients)

  24 hours Post Surgery

• Total Acetaminophen intake

  24 Hours post surgery

• Total NSAID intake

  24 hours Post Surgery

• Incidence of atrial fibrillation

  during Hospital Stay

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Intravenous normal saline at a standard dose of 0.5mcg/kg/hr continued to postop until extubation.

Drug: Saline

Dexmedotimidine Group

ACTIVE COMPARATOR

Intravenous dexmedetomidine infusion started after induction at a standard dose of 0.5mcg/kg/hr and continued until extubation.

Drug: Dexmedetomidine Injectable Solution

Interventions

Dexmedetomidine Injectable Solution DRUG

Intravenous dexmedetomidine infusion started after induction at a standard dose of 0.5mcg/kg/hr and continued until extubation.

Also known as: Precedex, Hospira

Dexmedotimidine Group

Saline DRUG

Intravenous normal saline at a standard dose of 0.5mcg/kg/hr continued to postop until extubation.

Also known as: solution of Sodium Chloride

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be between 18 years old and 100 years old. Both men and women will be eligible for this study. We will aim to have approximately 50% men and 50% women. People of all races and ethnic origins are eligible.
• Patients should be undergoing CABG (coronary artery bypass grafting ) under general anesthesia with CPB (Cardiopulmonary bypass).

You may not qualify if:

• Patients will be excluded who are receiving valve replacement with CABG, Class I emergent CABG, receiving regional anesthesia, clinically significant preoperative neurologic, cardiac, pulmonary, renal, or hepatic disease that cannot tolerate dexmedetomidine infusion, or reported allergy to dexmedetomidine. People taking chronic opioid will also be excluded from the study.

Sponsors & Collaborators

• Wayne State University: lead

Related Publications (2)

• Zubrzycki M, Liebold A, Skrabal C, Reinelt H, Ziegler M, Perdas E, Zubrzycka M. Assessment and pathophysiology of pain in cardiac surgery. J Pain Res. 2018 Aug 24;11:1599-1611. doi: 10.2147/JPR.S162067. eCollection 2018.

  PMID: 30197534 BACKGROUND

• Tang C, Xia Z. Dexmedetomidine in perioperative acute pain management: a non-opioid adjuvant analgesic. J Pain Res. 2017 Aug 11;10:1899-1904. doi: 10.2147/JPR.S139387. eCollection 2017.

  PMID: 28860845 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Model Details: This Study will be consist of two arms one treatment arm and one control arm.

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 9, 2022
• Study Start: September 6, 2022
• Primary Completion: July 10, 2023
• Study Completion: May 9, 2024
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share