Back to resultsANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
Primary Purpose
Acute Pain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ANI-guided opioid administration
Standard opioid administration
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility 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
Sites / Locations
- Parkland Health & Hospital System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard opioid administration
ANI-guided opioid administration
Arm Description
Intraoperative opioid will be administered by guiding standard practice
Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)
Outcomes
Primary Outcome Measures
The incidence of severe postoperative pain
The primary outcome will be the NRS pain scores reported during recovery
Secondary Outcome Measures
The incidence of pain medication use
The total amounts of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU)
The incidence of postoperative nausea/vomiting in post-anesthesia care unit (PACU)
The incidence of nausea/vomiting reported during recovery
The incidence of minimal pain
The percent of subjects with minimal pain (NPS < 3) in post-anesthesia care unit (PACU)
Full Information
NCT ID
NCT03684590
First Posted
September 24, 2018
Last Updated
March 29, 2023
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03684590
Brief Title
ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard opioid administration
Arm Type
Active Comparator
Arm Description
Intraoperative opioid will be administered by guiding standard practice
Arm Title
ANI-guided opioid administration
Arm Type
Experimental
Arm Description
Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)
Intervention Type
Device
Intervention Name(s)
ANI-guided opioid administration
Intervention Description
Intraoperative opioid will be administered guided by analgesia nociceptive index (ANI) values measured by ANI monitor (MetroDoloris Medical Systems, Lille, France)
Intervention Type
Other
Intervention Name(s)
Standard opioid administration
Intervention Description
Intraoperative opioid will be administered according to standard practice during surgery.
Primary Outcome Measure Information:
Title
The incidence of severe postoperative pain
Description
The primary outcome will be the NRS pain scores reported during recovery
Time Frame
postoperative recovery period
Secondary Outcome Measure Information:
Title
The incidence of pain medication use
Description
The total amounts of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU)
Time Frame
Perioperative and postoperative recovery period
Title
The incidence of postoperative nausea/vomiting in post-anesthesia care unit (PACU)
Description
The incidence of nausea/vomiting reported during recovery
Time Frame
Postoperative recovery period
Title
The incidence of minimal pain
Description
The percent of subjects with minimal pain (NPS < 3) in post-anesthesia care unit (PACU)
Time Frame
Postoperative recovery period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Moon, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Health & Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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23392233
Citation
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ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
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