Trial Summary
What is the purpose of this trial?This study aims to be a randomized, controlled study of ANI-guided opioid administration versus standard clinical practice in surgical patients undergoing general anesthesia with balanced sevoflurane-fentanyl. Patients will be randomly assigned to 2 groups- ANI vs. standard care. The intraoperative and postoperative management of all patients will be standardized by protocol. The PACU nurses and postop assessor will be blinded as to which group the patient is in.
Eligibility Criteria
This trial is for adults aged 18-75, with a BMI of 19-35 kg/m2, undergoing abdominal or spinal surgery under general anesthesia with sevoflurane-fentanyl. Participants must speak English or Spanish and have no advanced lung or heart disease. Excluded are those on certain heart medications, chronic opioids users, pregnant/nursing women, and those with irregular heart rhythms.Inclusion Criteria
You are in good to excellent overall health.
Your body mass index (BMI) is between 19 and 35.
Willing and able to consent in English or Spanish
+4 more
Exclusion Criteria
Patient refusal
Patient does not speak English or Spanish
Your heart rhythm is not regular.
+9 more
Participant Groups
The study compares ANI-guided opioid administration to standard care in managing pain during and after surgery. It's randomized: patients are put into the ANI group or standard care by chance. The team assessing post-surgery recovery won't know which group patients were in to avoid bias.
2Treatment groups
Experimental Treatment
Active Control
Group I: ANI-guided opioid administrationExperimental Treatment1 Intervention
Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)
Group II: Standard opioid administrationActive Control1 Intervention
Intraoperative opioid will be administered by guiding standard practice
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Parkland Health & Hospital SystemDallas, TX
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Who Is Running the Clinical Trial?
University of Texas Southwestern Medical CenterLead Sponsor