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Behavioural Intervention

ANI-Guided Opioid Administration for Acute Pain During Surgery

N/A
Waitlist Available
Led By Tiffany Moon, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative recovery period
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether a computer-guided system for administering opioids during surgery is better than standard care.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include typical reactions to opioids such as nausea, vomiting, constipation, drowsiness or respiratory depression. Since it involves surgical procedures under anesthesia, risks associated with general anesthesia also apply.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative recovery period, an average of 1 hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative recovery period, an average of 1 hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Incidence of Severe Postoperative Pain
Secondary study objectives
The Incidence of Minimal Pain
The Incidence of Pain Medication Use
The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,082 Previous Clinical Trials
1,057,531 Total Patients Enrolled
1 Trials studying Acute Pain
39 Patients Enrolled for Acute Pain
Tiffany Moon, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
8 Previous Clinical Trials
4,983 Total Patients Enrolled

Media Library

ANI-guided opioid administration (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03684590 — N/A
Acute Pain Research Study Groups: Standard opioid administration, ANI-guided opioid administration
Acute Pain Clinical Trial 2023: ANI-guided opioid administration Highlights & Side Effects. Trial Name: NCT03684590 — N/A
ANI-guided opioid administration (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03684590 — N/A
~16 spots leftby Nov 2025
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