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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard opioid administration | Active Comparator | Intraoperative opioid will be administered by guiding standard practice |
|
| ANI-guided opioid administration | Experimental | Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANI-guided opioid administration | Device | Intraoperative opioid will be administered guided by analgesia nociceptive index (ANI) values measured by ANI monitor (MetroDoloris Medical Systems, Lille, France) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Moon, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Health & Hospital System | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23392233 | Background | 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. | |
| 11020770 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | ANI-guided Opioid Administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Incidence of Severe Postoperative Pain | The primary outcome will be the NRS pain scores reported during recovery | Posted | Count of Participants | Participants | postoperative recovery period, an average of 1 hour |
|
24 hours post-op
All patients that were enrolled were healthy individuals and therefore not at risk for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Moon, MD | University of Texas Southwestern | 2145345456 | tiffany.moon@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2019 | Mar 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard opioid administration | Other | Intraoperative opioid will be administered according to standard practice during surgery. |
|
The incidence of nausea/vomiting reported during recovery |
| Postoperative recovery period |
| The Incidence of Minimal Pain | The percent of subjects with minimal pain (NPS < 3) in post-anesthesia care unit (PACU) | Postoperative recovery period |
| 12873949 | Background | 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. |
| 23592690 | Background | 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. |
| 26982116 | Background | 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. |
| 27771314 | Background | 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. |
| 25814108 | Background | 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. |
| 24237004 | Background | 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. |
| 23059501 | Background | 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. |
| 24829420 | Background | 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. |
| 22454275 | Background | 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. |
| 23471754 | Background | 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. |
| 23170802 | Background | 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. |
| 28598927 | Background | 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. |
| 25540069 | Background | 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. |
| 28631050 | Background | 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. |
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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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) | Posted | Mean | Standard Deviation | micrograms | 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 | Posted | Count of Participants | Participants | Postoperative recovery period |
|
|
|
| Secondary | The Incidence of Minimal Pain | The percent of subjects with minimal pain (NPS < 3) in post-anesthesia care unit (PACU) | Posted | Count of Participants | Participants | Postoperative recovery period |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 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) | 0 | 53 | 0 | 53 | 0 | 53 |
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