Trials / Completed
CompletedNCT03684590
ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
A Prospective, Randomized, PACU Blinded Study to Compare ANI-guided Analgesic Administration Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ANI-guided opioid administration | Intraoperative opioid will be administered guided by analgesia nociceptive index (ANI) values measured by ANI monitor (MetroDoloris Medical Systems, Lille, France) |
| OTHER | Standard opioid administration | Intraoperative opioid will be administered according to standard practice during surgery. |
Timeline
- Start date
- 2019-07-30
- Primary completion
- 2023-03-06
- Completion
- 2023-03-06
- First posted
- 2018-09-25
- Last updated
- 2025-04-30
- Results posted
- 2024-06-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03684590. Inclusion in this directory is not an endorsement.