Low Remifentanil Target Controlled Infusions for Cardiac Surgery
Early Extubation After Cardiac Surgery: What Is the Appropriate Target Remifentanil Effect-Site Concentration?
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2014
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2019
CompletedJuly 18, 2019
March 1, 2019
5 years
January 9, 2014
July 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to tracheal extubation
the times from skin closure to v
for 4 hours after surgery
Secondary Outcomes (7)
times to spontaneous eye opening
for 5 hours during surgery
times from skin closure to return of spontaneous breathing
for 4 hours after surgery
the number of changes in propofol and remifentanil target infusions
for 6 hours during surgery
Number of patients who will need changes in remifentanil effect site concentrations
For 6 hours during surgery
rescue doses of medications
for 6 hours during surgery
- +2 more secondary outcomes
Study Arms (3)
Ce 1 ng/ml
ACTIVE COMPARATORTCI Remifentanil Ce 1 ng/ml
Ce 2 ng/ml
ACTIVE COMPARATORTCI Remifentanil Ce 2 ng/ml
Ce 3 ng/ml
PLACEBO COMPARATORRemifentanil Ce 3 ng/ml
Interventions
Eligibility Criteria
You may qualify if:
- Older than 18 years
- American Society of Anesthesiologists class III and IV
- eligible for early extubation
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dammam University
Khobar, Eastern Province, 31952, Saudi Arabia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2014
First Posted
January 13, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2019
Study Completion
May 15, 2019
Last Updated
July 18, 2019
Record last verified: 2019-03