Trial Outcomes & Findings for ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia (NCT NCT03684590)

NCT ID: NCT03684590

Last Updated: 2025-04-30

Results Overview

The primary outcome will be the NRS pain scores reported during recovery

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: postoperative recovery period, an average of 1 hour
• Results posted on: 2025-04-30

Participant Flow

Participant milestones

Measure	Standard Opioid Administration Intraoperative opioid will be administered by guiding standard practice Standard opioid administration: Intraoperative opioid will be administered according to standard practice during surgery.	ANI-guided Opioid Administration Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI) 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)
Overall Study STARTED	49	53
Overall Study COMPLETED	49	53
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia

Baseline characteristics by cohort

Measure	Standard Opioid Administration n=49 Participants Intraoperative opioid will be administered by guiding standard practice Standard opioid administration: Intraoperative opioid will be administered according to standard practice during surgery.	ANI-guided Opioid Administration n=53 Participants Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI) 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)	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	52 Participants n=7 Participants	101 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	42.69 years n=5 Participants	45.31 years n=7 Participants	43.87 years n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	52 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=5 Participants	37 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	53 participants n=7 Participants	102 participants n=5 Participants

PRIMARY outcome

Timeframe: postoperative recovery period, an average of 1 hour

The primary outcome will be the NRS pain scores reported during recovery

Outcome measures

Measure	Standard Opioid Administration n=49 Participants Intraoperative opioid will be administered by guiding standard practice Standard opioid administration: Intraoperative opioid will be administered according to standard practice during surgery.	ANI-guided Opioid Administration n=53 Participants Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI) 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)
The Incidence of Severe Postoperative Pain	49 Participants	53 Participants

SECONDARY outcome

Timeframe: Perioperative and postoperative recovery period

The total amounts of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU)

Outcome measures

Measure	Standard Opioid Administration n=49 Participants Intraoperative opioid will be administered by guiding standard practice Standard opioid administration: Intraoperative opioid will be administered according to standard practice during surgery.	ANI-guided Opioid Administration n=53 Participants Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI) 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)
The Incidence of Pain Medication Use	224.1 micrograms Standard Deviation 140.5	294.4 micrograms Standard Deviation 170.3

SECONDARY outcome

Timeframe: Postoperative recovery period

The incidence of nausea/vomiting reported during recovery

Outcome measures

Measure	Standard Opioid Administration n=49 Participants Intraoperative opioid will be administered by guiding standard practice Standard opioid administration: Intraoperative opioid will be administered according to standard practice during surgery.	ANI-guided Opioid Administration n=53 Participants Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI) 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)
The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Postoperative recovery period

The percent of subjects with minimal pain (NPS < 3) in post-anesthesia care unit (PACU)

Outcome measures

Measure	Standard Opioid Administration n=49 Participants Intraoperative opioid will be administered by guiding standard practice Standard opioid administration: Intraoperative opioid will be administered according to standard practice during surgery.	ANI-guided Opioid Administration n=53 Participants Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI) 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)
The Incidence of Minimal Pain	12 Participants	22 Participants

Adverse Events

Standard Opioid Administration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ANI-guided Opioid Administration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tiffany Moon, MD

University of Texas Southwestern

Phone: 2145345456

Email: tiffany.moon@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place