ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
NCT ID: NCT03684590
Last Updated: 2025-04-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
102 participants
INTERVENTIONAL
2019-07-30
2023-03-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia
NCT02193412
Assessment of Oxygenation With Oxygen Reserve Index for General Anesthesia
NCT04698863
Evaluation Of The Analgesia Nociception Index vs. Surgical Pleth Index Under General And Regional Anaesthesia
NCT02744573
Comparison of Total Oxidant and Total Antioxidant Capacities in Low-Flow and High-Flow General Anesthesia
NCT05590312
Comparison of the Effects of Oxycodone Versus Fentanyl on Airway Reflex to Tracheal Extubation and Postoperative Pain
NCT03204045
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Standard opioid administration
Intraoperative opioid will be administered according to standard practice during surgery.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Texas Southwestern Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tiffany B Moon
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tiffany Moon, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Parkland Health & Hospital System
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STU-2018-0096
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.