CompletedNot Applicable

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

United States102 participantsStarted 2019-07-30

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Incidence of Severe Postoperative Pain

Timeframe: postoperative recovery period, an average of 1 hour

Trial details

NCT IDNCT03684590

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-06

Results submitted2024-03-20

View on ClinicalTrials.gov More Acute Pain trials