NCT03684590

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

July 30, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 12, 2024

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

3.6 years

First QC Date

September 24, 2018

Results QC Date

March 20, 2024

Last Update Submit

April 14, 2025

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • The Incidence of Severe Postoperative Pain

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

    postoperative recovery period, an average of 1 hour

Secondary Outcomes (3)

  • The Incidence of Pain Medication Use

    Perioperative and postoperative recovery period

  • The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU)

    Postoperative recovery period

  • The Incidence of Minimal Pain

    Postoperative recovery period

Study Arms (2)

Standard opioid administration

ACTIVE COMPARATOR

Intraoperative opioid will be administered by guiding standard practice

Other: Standard opioid administration

ANI-guided opioid administration

EXPERIMENTAL

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

Device: ANI-guided opioid administration

Interventions

ANI-guided opioid administrationDEVICE

Intraoperative opioid will be administered guided by analgesia nociceptive index (ANI) values measured by ANI monitor (MetroDoloris Medical Systems, Lille, France)

ANI-guided opioid administration
Standard opioid administrationOTHER

Intraoperative opioid will be administered according to standard practice during surgery.

Standard opioid administration

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • ASA 1-2
  • BMI 19-35 kg/m2
  • Patients undergoing surgery with general anesthesia with sevoflurane- fentanyl
  • Planned abdominal or spinal surgery lasting 1-3 hours
  • Willing and able to consent in English or Spanish
  • No current history of advanced pulmonary or cardiovascular disease

You may not qualify if:

  • Age less than 18 or older than 75
  • Patient does not speak English or Spanish
  • Patient refusal
  • Monitored anesthesia care (MAC) or regional anesthesia planned
  • Pregnant or nursing women
  • "Stat" (emergent) cases
  • ECG rhythm other than regular sinus rhythm
  • Implanted pacemakers
  • On antimuscarinic agents, alpha 2 agonists, antiarrhythmics, or beta blockers
  • Presence of pacemaker
  • Autonomic nervous system disorder
  • Use of chronic opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

Related Publications (16)

  • Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

    PMID: 23392233BACKGROUND

  • Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.

    PMID: 11020770BACKGROUND

  • Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

    PMID: 12873949BACKGROUND

  • Boselli E, Daniela-Ionescu M, Begou G, Bouvet L, Dabouz R, Magnin C, Allaouchiche B. Prospective observational study of the non-invasive assessment of immediate postoperative pain using the analgesia/nociception index (ANI). Br J Anaesth. 2013 Sep;111(3):453-9. doi: 10.1093/bja/aet110. Epub 2013 Apr 16.

    PMID: 23592690BACKGROUND

  • Bluth T, Pelosi P, de Abreu MG. The obese patient undergoing nonbariatric surgery. Curr Opin Anaesthesiol. 2016 Jun;29(3):421-9. doi: 10.1097/ACO.0000000000000337.

    PMID: 26982116BACKGROUND

  • Budiansky AS, Margarson MP, Eipe N. Acute pain management in morbid obesity - an evidence based clinical update. Surg Obes Relat Dis. 2017 Mar;13(3):523-532. doi: 10.1016/j.soard.2016.09.013. Epub 2016 Sep 19.

    PMID: 27771314BACKGROUND

  • Lovich-Sapola J, Smith CE, Brandt CP. Postoperative pain control. Surg Clin North Am. 2015 Apr;95(2):301-18. doi: 10.1016/j.suc.2014.10.002. Epub 2015 Jan 24.

    PMID: 25814108BACKGROUND

  • Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.

    PMID: 24237004BACKGROUND

  • Borsook D, Kussman BD, George E, Becerra LR, Burke DW. Surgically induced neuropathic pain: understanding the perioperative process. Ann Surg. 2013 Mar;257(3):403-12. doi: 10.1097/SLA.0b013e3182701a7b.

    PMID: 23059501BACKGROUND

  • Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.

    PMID: 24829420BACKGROUND

  • Jeanne M, Clement C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28.

    PMID: 22454275BACKGROUND

  • Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.

    PMID: 23471754BACKGROUND

  • Sabourdin N, Arnaout M, Louvet N, Guye ML, Piana F, Constant I. Pain monitoring in anesthetized children: first assessment of skin conductance and analgesia-nociception index at different infusion rates of remifentanil. Paediatr Anaesth. 2013 Feb;23(2):149-55. doi: 10.1111/pan.12071. Epub 2012 Nov 21.

    PMID: 23170802BACKGROUND

  • Upton HD, Ludbrook GL, Wing A, Sleigh JW. Intraoperative "Analgesia Nociception Index"-Guided Fentanyl Administration During Sevoflurane Anesthesia in Lumbar Discectomy and Laminectomy: A Randomized Clinical Trial. Anesth Analg. 2017 Jul;125(1):81-90. doi: 10.1213/ANE.0000000000001984.

    PMID: 28598927BACKGROUND

  • Szental JA, Webb A, Weeraratne C, Campbell A, Sivakumar H, Leong S. Postoperative pain after laparoscopic cholecystectomy is not reduced by intraoperative analgesia guided by analgesia nociception index (ANI(R)) monitoring: a randomized clinical trial. Br J Anaesth. 2015 Apr;114(4):640-5. doi: 10.1093/bja/aeu411. Epub 2014 Dec 23.

    PMID: 25540069BACKGROUND

  • Dundar N, Kus A, Gurkan Y, Toker K, Solak M. Analgesia nociception index (ani) monitoring in patients with thoracic paravertebral block: a randomized controlled study. J Clin Monit Comput. 2018 Jun;32(3):481-486. doi: 10.1007/s10877-017-0036-9. Epub 2017 Jun 19.

    PMID: 28631050BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Tiffany Moon, MD
Organization
University of Texas Southwestern
tiffany.moon@utsouthwestern.edu
2145345456

Study Officials

  • Tiffany Moon, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 25, 2018

Study Start

July 30, 2019

Primary Completion

March 6, 2023

Study Completion

March 6, 2023

Last Updated

April 30, 2025

Results First Posted

June 12, 2024

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)