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Low Remifentanil Target Controlled Infusions for Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02033629
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dammam University

Brief Summary:
The development of target effect-site controlled concentrations (TCI) of remifentanil have gained increasing acceptance during cardiac surgery as regarding the resulting of hemodynamic stability and early extubation. The use of low-dose opioid technique has been progressively used nowadays because of its ceiling effect to attenuate cardiovascular responses to noxious stimuli. We hypothesize that the use of low target remifentanil effect site concentrations may provide comparable shorter times to tracheal extubation and hemodynamic stability to the use of high remifentanil Ce during target-controlled propofol anesthesia for cardiac surgery.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Drug: Ce 1 ng/ml Drug: Ce 2 ng/ml Drug: Ce 3 ng/ml Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Extubation After Cardiac Surgery: What Is the Appropriate Target Remifentanil Effect-Site Concentration?
Study Start Date : May 2014
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: Ce 1 ng/ml
TCI Remifentanil Ce 1 ng/ml
Drug: Ce 1 ng/ml
TCI Remifentanil Ce 1 ng/ml

Active Comparator: Ce 2 ng/ml
TCI Remifentanil Ce 2 ng/ml
Drug: Ce 2 ng/ml
TCI Remifentanil Ce 2 ng/ml

Placebo Comparator: Ce 3 ng/ml
Remifentanil Ce 3 ng/ml
Drug: Ce 3 ng/ml
TCI Remifentanil Ce 3 ng/ml




Primary Outcome Measures :
  1. time to tracheal extubation [ Time Frame: for 4 hours after surgery ]
    the times from skin closure to v


Secondary Outcome Measures :
  1. times to spontaneous eye opening [ Time Frame: for 5 hours during surgery ]
    times from skin closure to spontaneous eye opening

  2. times from skin closure to return of spontaneous breathing [ Time Frame: for 4 hours after surgery ]
    times from skin closure to return of spontaneous breathing (defined as a respiratory rate >12 breaths/min and an arterial oxygen saturation >95%);

  3. the number of changes in propofol and remifentanil target infusions [ Time Frame: for 6 hours during surgery ]
    the number of changes in propofol Ce and remifentanil Ce

  4. Number of patients who will need changes in remifentanil effect site concentrations [ Time Frame: For 6 hours during surgery ]
    the number of patients who will need changes in remifentanil Ce

  5. rescue doses of medications [ Time Frame: for 6 hours during surgery ]
    rescue doses of nitroglycerin, esmolol, phenylephrine, and ephedrine

  6. incidences of light anesthesia [ Time Frame: For 6 hours during surgery ]
    incidences of light anesthesia and awareness

  7. Cost of Medications [ Time Frame: for 6 hour during surgery ]
    Cost of Medications



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 18 years
  • American Society of Anesthesiologists class III and IV
  • eligible for early extubation

Exclusion Criteria:

  • uncontrolled hypertension
  • ischemic heart disease
  • left ventricular ejection fraction ≤45%
  • mean pulmonary artery pressure ≥50 mm Hg
  • critical aortic stenosis
  • pulmonary diseases
  • hepatic diseases
  • renal diseases
  • neuromuscular diseases
  • neuropsychiatric diseases
  • endocrine diseases
  • body mass index ≥40 kg/m2
  • pregnancy
  • use of antipsychotics
  • use of alcohol
  • drug abuse
  • repeat surgery
  • emergency surgery
  • those requiring preoperative circulatory support
  • those whose electrocardiographic characteristics would interfere with ST-segment monitoring

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033629


Locations
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Saudi Arabia
Dammam University
Khobar, Eastern, Saudi Arabia, 31952
Sponsors and Collaborators
Dammam University

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Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT02033629     History of Changes
Other Study ID Numbers: Anesth-JAN14
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: March 2019
Keywords provided by Dammam University:
Anesthesia
remifentanil
propofol
target-controlled infusion
cardiac surgery
Additional relevant MeSH terms:
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Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents