Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients

NCT00345384 | Completed Phase 1 Results

• 1 other identifier: 005-201
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients undergoing thoracic surgery after discharge from PACU or ICU.

Conditions

Post-operative Pain; Respiratory Depression

Keywords

Dexmedetomidine; Sedation; Opioid; Respiratory depression

Outcome Measures

Primary Outcomes (1)

• Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm.

  To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient.

  An average of 24 hours, up to 30 hours per patient

Secondary Outcomes (1)

• Measure the Amount of Respiratory Depression in Each Groups

  Hours 6 to 16

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

One group (placebo comparator) will receive a normal saline infusion, set at a rate as if it were the active drug.

Other: Placebo (Normal Saline)

Dexmedetomidine

ACTIVE COMPARATOR

The second group (the study group) will receive a continuous infusion of dexmedetomidine titrated from 0.1 - 0.5 mics/kg/h to control pain for up to 24 hours after they are admitted to an open nursing unit after discharge from the PACU or ICU

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine titrated over 24 hours

Also known as: Precedex, Dexdor Titrated 0.1 to 0.5 ug.kg.h-1

Dexmedetomidine

Placebo (Normal Saline) OTHER

Normal Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) class I, II or III
• Undergoing thoracic surgery on an inpatient basis
• Age 18 up to 85 years of age

You may not qualify if:

• Subject is pregnant and/or lactating
• Subject has a serious Central Nervous System (CNS)pathology/trauma that, per clinical judgment of the investigator, precludes responsiveness or survival.
• Subject for whom alpha-2 agonists are contraindicated
• Subject meets any of the following cardiovascular criteria:
• Acute unstable angina (defined during current hospital stay)
• Suspicion of acute myocardial infarction.
• Subject has participated in a trial with any experimental drug within 30 days prior to enrollment in the study, or has ever been enrolled in this study.
• Subject is unable to undergo any procedures required by the protocol.
• Subject has acute hepatitis, a history or presence of chronic hepatitis, and /or has had a positive result for Hepatitis B surface antigen test.
• Subject requires dialysis (e.g., hemodialysis, peritoneal dialysis, CVVHD).
• Subject has a known, uncontrolled seizure disorder.
• Subject has a known psychiatric illness that could confound a normal response to sedative treatment.
• Subject is terminally ill with a life duration expectancy of \< 60 days.
• Subject has a history of Obstructive Sleep Apnea.
• Oxygen saturation is \< 90% on room air.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center - Department of Anesthesiology

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Respiratory Insufficiency

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Pilot study with small numbers of participants.

Results Point of Contact

• Title: President Baylor Research Institute
• Organization: Baylor Research Institute

researchclinicaltrials@baylorhealth.edu

214-820-3296

Study Officials

• Michael Ramsay, MD, MD

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2006
• First Posted: June 28, 2006
• Study Start: May 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 8, 2016
• Results First Posted: August 20, 2015

Record last verified: 2016-01

Locations

US (1)