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

Acute Pain Clinical Trial

Official title:

A Prospective, Randomized, PACU Blinded Study to Compare ANI-guided Analgesic Administration Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03684590
• Other study ID #: STU-2018-0096
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: March 6, 2025

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: March 6, 2025
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-75 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Pain

Intervention

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)

Other:
• Standard opioid administration
Intraoperative opioid will be administered according to standard practice during surgery.

Locations

Country	Name	City	State
United States	Parkland Health & Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Incidence of Pain Medication Use	The total amounts of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU)	Perioperative and postoperative recovery period
Secondary	The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU)	The incidence of nausea/vomiting reported during recovery	Postoperative recovery period
Secondary	The Incidence of Minimal Pain	The percent of subjects with minimal pain (NPS < 3) in post-anesthesia care unit (PACU)	Postoperative recovery period