ANI-Guided Opioid Administration for Acute Pain During Surgery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Antimuscarinics, Alpha 2 agonists

Disqualifiers: Pregnancy, Pacemaker, Chronic opioids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Intraoperative period

102 Participants Needed

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.

Research Team

Tiffany Moon, MD

Principal Investigator

University of Texas Southwestern Medical Center

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

Exclusion Criteria

Patient refusal

Your heart rhythm is not regular.

You have a pacemaker.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ANI-guided or standard care opioid administration during surgery

Intraoperative period

1 visit (in-person, surgical procedure)

Postoperative Recovery

Participants are monitored for pain, nausea, and opioid use in the PACU

Postoperative recovery period, an average of 1 hour

1 visit (in-person, PACU)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ANI-guided opioid administration
• Standard opioid administration

Trial Overview 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.

Participant Groups

Group I: ANI-guided opioid administration Experimental Treatment 1 Intervention

Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)

Group II: Standard opioid administration Active Control 1 Intervention

Intraoperative opioid will be administered by guiding standard practice

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+