Acute Pain
Conditions
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.
Interventions
DEVICEANI-guided opioid administration
Intraoperative opioid will be administered guided by analgesia nociceptive index (ANI) values measured by ANI monitor (MetroDoloris Medical Systems, Lille, France)
OTHERStandard opioid administration
Intraoperative opioid will be administered according to standard practice during surgery.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Opioid Administration Intraoperative opioid will be administered by guiding standard practice
Standard opioid administration: Intraoperative opioid will be administered according to standard practice during surgery. | 49 |
| ANI-guided Opioid Administration Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)
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) | 53 |
| Total | 102 |
Baseline characteristics
| Characteristic | Standard Opioid Administration | ANI-guided Opioid Administration | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 52 Participants | 101 Participants |
| Age, Continuous | 42.69 years | 45.31 years | 43.87 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 37 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 16 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 49 participants | 53 participants | 102 participants |
| Sex: Female, Male Female | 49 Participants | 52 Participants | 101 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 53 |
| other Total, other adverse events | 0 / 49 | 0 / 53 |
| serious Total, serious adverse events | 0 / 49 | 0 / 53 |
Outcome results
Primary
The Incidence of Severe Postoperative Pain
The primary outcome will be the NRS pain scores reported during recovery
Time frame: postoperative recovery period, an average of 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Opioid Administration | The Incidence of Severe Postoperative Pain | 49 Participants |
| ANI-guided Opioid Administration | The Incidence of Severe Postoperative Pain | 53 Participants |
Secondary
The Incidence of Minimal Pain
The percent of subjects with minimal pain (NPS \< 3) in post-anesthesia care unit (PACU)
Time frame: Postoperative recovery period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Opioid Administration | The Incidence of Minimal Pain | 12 Participants |
| ANI-guided Opioid Administration | The Incidence of Minimal Pain | 22 Participants |
Secondary
The Incidence of Pain Medication Use
The total amounts of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU)
Time frame: Perioperative and postoperative recovery period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Opioid Administration | The Incidence of Pain Medication Use | 224.1 micrograms | Standard Deviation 140.5 |
| ANI-guided Opioid Administration | The Incidence of Pain Medication Use | 294.4 micrograms | Standard Deviation 170.3 |
Secondary
The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU)
The incidence of nausea/vomiting reported during recovery
Time frame: Postoperative recovery period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Opioid Administration | The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU) | 0 Participants |
| ANI-guided Opioid Administration | The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU) | 0 Participants |