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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684590
Recruitment Status : Active, not recruiting
First Posted : September 25, 2018
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
Tiffany B Moon, University of Texas Southwestern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Pain Device: ANI-guided opioid administration Other: Standard opioid administration Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard opioid administration
Intraoperative opioid will be administered by guiding standard practice
 Other: Standard opioid administration
Intraoperative opioid will be administered according to standard practice during surgery.
Experimental: ANI-guided opioid administration
Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)
 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)


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of severe postoperative pain [ Time Frame: postoperative recovery period ]
    The primary outcome will be the NRS pain scores reported during recovery


Secondary Outcome Measures :
  1. The incidence of pain medication use [ Time Frame: Perioperative and postoperative recovery period ]
    The total amounts of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU)

  2. The incidence of postoperative nausea/vomiting in post-anesthesia care unit (PACU) [ Time Frame: Postoperative recovery period ]
    The incidence of nausea/vomiting reported during recovery

  3. The incidence of minimal pain [ Time Frame: Postoperative recovery period ]
    The percent of subjects with minimal pain (NPS < 3) in post-anesthesia care unit (PACU)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684590


Locations
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United States, Texas
Parkland Health & Hospital System
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Tiffany Moon, MD University of Texas Southwestern Medical Center
More Information
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Publications:

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Responsible Party: Tiffany B Moon, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03684590    
Other Study ID Numbers: STU-2018-0096
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents