Status:
COMPLETED
Trial Comparing Intrathecal Morphine With Placebo In Patients Undergoing Robotic Cardiac Surgery
Lead Sponsor:
University of Chicago
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a randomized clinical trial in patients undergoing robotic myocardial revascularization with intraoperative extubation. Patients will be randomized into placebo or intrathecal morphine groups ...
Detailed Description
Following Institutional Review Board approval and informed patient consent, 120 patients scheduled for elective robotic myocardial revascularization without cardiopulmonary bypass and anticipated intr...
Eligibility Criteria
Inclusion
- • patient undergoing elective robotic myocardial revascularization without anticipated use of cardiopulmonary bypass and with anticipated intraoperative tracheal extubation.
Exclusion
- Emergency surgery
- Preoperative use of inotropes/IABP
- Preoperative use of opoids
- Ejection fraction less than 40%
- Anticipated use of cardiopulmonary bypass
- Previous cardiothoracic surgery
- Anticipated postoperative tracheal intubation
- severe pulmonary disease
- morbid obesity (BMI \>35 kg/m2)
- severe hepatic impairment
- severe renal dysfunction (creatinine \> 1.5)
- any contraindication to intrathecal injection (patient refusal, difficult patient anatomy, pre-existing coagulopathy, morphine allergy)
Key Trial Info
Start Date :
June 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03241485
Start Date
June 19 2018
End Date
September 1 2020
Last Update
November 23 2021
Active Locations (1)
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1
University of Chicago Hospital
Chicago, Illinois, United States, 60637