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

Not Applicable

Active, not recruiting

• Conditions: Acute Pain
• Interventions: Other: Standard opioid administration; Device: ANI-guided opioid administration

• Registration Number: NCT03684590
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Study Start: 2019-07-30
• Primary Completion: 2023-03-06
• Results First Submitted: 2024-03-20
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Results First Posted: 2024-06-12
• Last Update Posted: 2024-06-12
• Study Completion: 2025-03-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard opioid administration	Standard opioid administration	Intraoperative opioid will be administered by guiding standard practice
ANI-guided opioid administration	ANI-guided opioid administration	Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)

Primary Outcome Measures

Name	Time	Method
The Incidence of Severe Postoperative Pain	postoperative recovery period, an average of 1 hour	The primary outcome will be the NRS pain scores reported during recovery

Secondary Outcome Measures

Name	Time	Method
The Incidence of Pain Medication Use	Perioperative and postoperative recovery period	The total amounts of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU)
The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU)	Postoperative recovery period	The incidence of nausea/vomiting reported during recovery
The Incidence of Minimal Pain	Postoperative recovery period	The percent of subjects with minimal pain (NPS \< 3) in post-anesthesia care unit (PACU)

Trial Locations

Locations (1)

Parkland Health & Hospital System; 🇺🇸 Dallas, Texas, United States