An interventional study of ANI-guided opioid administration and Standard opioid administration in Acute Pain, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 102 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intraoperative opioid will be administered by guiding standard practice
Other: Standard opioid administration
Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)
Device: ANI-guided opioid administration
Intraoperative opioid will be administered guided by analgesia nociceptive index (ANI) values measured by ANI monitor (MetroDoloris Medical Systems, Lille, France)
Intraoperative opioid will be administered according to standard practice during surgery.
The Incidence of Severe Postoperative Pain
The primary outcome will be the NRS pain scores reported during recovery
Time frame: postoperative recovery period, an average of 1 hour
The Incidence of Pain Medication Use
The total amounts of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU)
Time frame: Perioperative and postoperative recovery period
The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU)
The incidence of nausea/vomiting reported during recovery
Time frame: Postoperative recovery period
The Incidence of Minimal Pain
The percent of subjects with minimal pain (NPS \< 3) in post-anesthesia care unit (PACU)
Time frame: Postoperative recovery period
| Milestone | Standard Opioid Administration | ANI-guided Opioid Administration |
|---|---|---|
| Started | 49 | 53 |
| Completed | 49 | 53 |
| Not completed | 0 | 0 |
The primary outcome will be the NRS pain scores reported during recovery
| Participants | Standard Opioid Administration | ANI-guided Opioid Administration |
|---|---|---|
| The Incidence of Severe Postoperative Pain | 49 | 53 |
The total amounts of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU)
| micrograms | Standard Opioid Administration | ANI-guided Opioid Administration |
|---|---|---|
| The Incidence of Pain Medication Use | 224.1 ± 140.5 | 294.4 ± 170.3 |
The incidence of nausea/vomiting reported during recovery
| Participants | Standard Opioid Administration | ANI-guided Opioid Administration |
|---|---|---|
| The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU) | 0 | 0 |
The percent of subjects with minimal pain (NPS \< 3) in post-anesthesia care unit (PACU)
| Participants | Standard Opioid Administration | ANI-guided Opioid Administration |
|---|---|---|
| The Incidence of Minimal Pain | 12 | 22 |
Collected over 24 hours post-op. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Opioid Administration | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| ANI-guided Opioid Administration | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Age, Categorical(Participants) | Standard Opioid Administration | ANI-guided Opioid Administration | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 49 | 52 | 101 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Standard Opioid Administration | ANI-guided Opioid Administration | Total |
|---|---|---|---|
| Mean | 42.69 (23 to 61) | 45.31 (29 to 67) | 43.87 (23 to 67) |
| Sex: Female, Male(Participants) | Standard Opioid Administration | ANI-guided Opioid Administration | Total |
|---|---|---|---|
| Female | 49 | 52 | 101 |
| Male | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Standard Opioid Administration | ANI-guided Opioid Administration | Total |
|---|---|---|---|
| Hispanic or Latino | 31 | 37 | 68 |
| Not Hispanic or Latino | 18 | 16 | 34 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Standard Opioid Administration | ANI-guided Opioid Administration | Total |
|---|---|---|---|
| United States | 49 | 53 | 102 |
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University of Texas Southwestern Medical Center