ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/31/2019 |
| Start Date: | May 2019 |
| End Date: | December 2020 |
| Contact: | Taylor Pak, BS |
| Email: | taylor.pak@utsouthwestern.edu |
| Phone: | 469-419-5790 |
A Prospective, Randomized, PACU Blinded Study to Compare ANI-guided Analgesic Administration 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. Patients will be followed in the PACU as well as on POD1 and 2 to
assess pain scores, return to normal activities of daily living, and any adverse events.
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. Patients will be followed in the PACU as well as on POD1 and 2 to
assess pain scores, return to normal activities of daily living, and any adverse events.
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
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