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Trial Comparing Intrathecal Morphine With Placebo In Patients Undergoing Robotic Cardiac Surgery

NCT03241485 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2021-11-23

Study results available
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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.

Conditions

Interventions

DRUG

Intrathecal morphine

5 micrograms/kilogram of intrathecal morphine administered in the spinal space, not to exceed 1mg

DRUG

Placebo

Saline intrathecal given in the same manner as the intervention groups.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Richa Dhawan, MD, MPH · University of Chicago Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2020-09-01
Completion
2020-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03241485 on ClinicalTrials.gov