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NCT Number: NCT03684590

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

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANI-guided opioid administration

Device

Intraoperative opioid will be administered guided by analgesia nociceptive index (ANI) values measured by ANI monitor (MetroDoloris Medical Systems, Lille, France)

Standard opioid administration

Other

Intraoperative opioid will be administered according to standard practice during surgery.

Primary outcomes

  1. The Incidence of Severe Postoperative Pain

    Time frame: postoperative recovery period, an average of 1 hour

    The primary outcome will be the NRS pain scores reported during recovery

Secondary outcomes

  1. The Incidence of Pain Medication Use

    Time frame: Perioperative and postoperative recovery period

    The total amounts of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU)

  2. The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU)

    Time frame: Postoperative recovery period

    The incidence of nausea/vomiting reported during recovery

  3. The Incidence of Minimal Pain

    Time frame: Postoperative recovery period

    The percent of subjects with minimal pain (NPS < 3) in post-anesthesia care unit (PACU)

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2018
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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