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 range18 Years – 75 Years

SexALL

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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

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