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Behavioural Intervention
ANI-Guided Opioid Administration for Acute Pain During Surgery
N/A
Waitlist Available
Led By Tiffany Moon, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative recovery period
Awards & highlights
Study Summary
This trial will study whether a computer-guided system for administering opioids during surgery is better than standard care.
Who is the study for?
This trial is for adults aged 18-75, with a BMI of 19-35 kg/m2, undergoing abdominal or spinal surgery under general anesthesia with sevoflurane-fentanyl. Participants must speak English or Spanish and have no advanced lung or heart disease. Excluded are those on certain heart medications, chronic opioids users, pregnant/nursing women, and those with irregular heart rhythms.Check my eligibility
What is being tested?
The study compares ANI-guided opioid administration to standard care in managing pain during and after surgery. It's randomized: patients are put into the ANI group or standard care by chance. The team assessing post-surgery recovery won't know which group patients were in to avoid bias.See study design
What are the potential side effects?
Potential side effects may include typical reactions to opioids such as nausea, vomiting, constipation, drowsiness or respiratory depression. Since it involves surgical procedures under anesthesia, risks associated with general anesthesia also apply.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ postoperative recovery period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative recovery period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
The incidence of minimal pain
The incidence of pain medication use
The incidence of postoperative nausea/vomiting in post-anesthesia care unit (PACU)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ANI-guided opioid administrationExperimental Treatment1 Intervention
Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)
Group II: Standard opioid administrationActive Control1 Intervention
Intraoperative opioid will be administered by guiding standard practice
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ANI-guided opioid administration
2019
N/A
~60
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,739 Total Patients Enrolled
2 Trials studying Acute Pain
113 Patients Enrolled for Acute Pain
Tiffany Moon, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
8 Previous Clinical Trials
4,978 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart rhythm is not regular.You have a pacemaker.You are in good to excellent overall health.Your body mass index (BMI) is between 19 and 35.You are younger than 18 or older than 75 years old.You have a disorder that affects your autonomic nervous system.You regularly use strong painkillers.You are scheduled to have monitored anesthesia care or regional anesthesia.You have a pacemaker implanted.You are currently taking certain types of medications for specific conditions.You are having surgery with a specific type of anesthesia called sevoflurane-fentanyl.You do not have severe lung or heart disease.You are between 18 and 75 years old.You are scheduled to have a 1-3 hour long surgery on your abdomen or spine.
Research Study Groups:
This trial has the following groups:- Group 1: Standard opioid administration
- Group 2: ANI-guided opioid administration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity to partake in this clinical research?
"In order to meet the requirements of this medical trial, participants must have a diagnosis that causes acute pain and be between 18-75 years old. Currently, they are seeking 60 individuals to take part in the study."
Answered by AI
Are there any age restrictions on enrolment in this trial?
"The requirements for this medical trial require that participants are between 18 and 75 years of age. There exist 20 trials specifically designed for those younger than 18, as well as 116 studies available to those aged 65 or above."
Answered by AI
Are there any openings available for participants of this research?
"As stated on clinicaltrials.gov, this particular trial is not currently open for enrollment; the first posting was made on July 30th 2019 and updated as recently as July 21st 2022. However, 145 other studies are actively recruiting patients at present time."
Answered by AI
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