Phase 4
Completed N=79
Trial Comparing Intrathecal Morphine With Placebo In Patients Undergoing Robotic Cardiac Surgery
Source: ClinicalTrials.gov NCT03241485 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Postoperative Morphine Consumption — 59; 28 Miligram
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 to assess postoperative pain scores and patient satisfaction. Patients will also be assessed for side effects from the intervention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Morphine Consumption |
59; 28 | — |
| SECONDARY Pain Score |
6; 1.2 | — |
| SECONDARY Patient Satisfaction |
9; 9.5 | — |
| SECONDARY Number of Participants With Nausea |
3; 12 | — |
| SECONDARY Number of Participants With Respiratory Depression |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- patient undergoing elective robotic myocardial revascularization without anticipated use of cardiopulmonary bypass and with anticipated intraoperative tracheal extubation.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03241485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.