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

Completed · Not applicable

Conditions studied: Acute Pain

In brief

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.

Key facts

Study ID

NCT03684590

Run by

University of Texas Southwestern Medical Center

People needed

102

Starts

2019-07-30

Expected to finish

2023-03-06

Last updated by the study team

2025-04-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Parkland Health & Hospital System — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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