Clinical trial NCT03684590: ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
Official title: A Prospective, Randomized, PACU Blinded Study to Compare ANI-guided Analgesic Administration Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The Incidence of Severe Postoperative Pain
timeFrame: postoperative recovery period, an average of 1 hour
Secondary outcomes:
measure: The Incidence of Pain Medication Use
timeFrame: Perioperative and postoperative recovery period
measure: The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU)
timeFrame: Postoperative recovery period
measure: The Incidence of Minimal Pain
timeFrame: Postoperative recovery period
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Tiffany Moon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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