N/A
N=102
ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT03684590 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: The Incidence of Severe Postoperative Pain — 49; 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ANI-guided opioid administration (Device); Standard opioid administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Severe Postoperative Pain |
49; 53 | — |
| SECONDARY The Incidence of Pain Medication Use |
224.1; 294.4 | — |
| SECONDARY The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU) |
0; 0 | — |
| SECONDARY The Incidence of Minimal Pain |
12; 22 | — |
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
Data sourced from ClinicalTrials.gov (NCT03684590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.