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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Pain

Intervention / Treatment
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* Device: ANI-guided opioid administration
* Other: Standard opioid administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard opioid administration<br>Intraoperative opioid will be administered by guiding standard practice | Other: Standard opioid administration<br>* Intraoperative opioid will be administered according to standard practice during surgery.<br>|
| Experimental: ANI-guided opioid administration<br>Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI) | Device: ANI-guided opioid administration<br>* Intraoperative opioid will be administered guided by analgesia nociceptive index (ANI) values measured by ANI monitor (MetroDoloris Medical Systems, Lille, France)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |