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

The University of Texas System (UT)

Status: Completed

Conditions: Acute Pain

Treatments: Other: Standard opioid administration; Device: ANI-guided opioid administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03684590

STU-2018-0096

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

Standard opioid administration

Active Comparator group

Description:

Intraoperative opioid will be administered by guiding standard practice

Treatment:

Other: Standard opioid administration

ANI-guided opioid administration

Experimental group

Description:

Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)

Treatment:

Device: ANI-guided opioid administration