Anxiety, Pain, Surgery
Conditions
Keywords
perioperative, surgery, pain, anxiety, post operative cognitive dysfunction, cognition
Brief summary
The overall objective of this proposal is to explore the association between the administration of the prebiotics GOS (trade name: Bimuno Travelaid; generic name:B galacto-oligosaccharides) with pain, anxiety, and cognitive function in the perioperative period. The investigators' central hypothesis is subjects who consume GOS in the perioperative period will demonstrate lower levels of salivary cortisol before, during, and after their operative procedures. In addition, the investigators expect subjects who consume GOS to have lower perceived levels of anxiety during the perioperative period. Finally, the investigators hypothesize that subjects who consume perioperative GOS will perform better on tests of cognition in the postoperative period. Such a finding would be beneficial in that administration of GOS in the perioperative period offers a safe and inexpensive adjunct to current medical management of perioperative anxiety.
Detailed description
AIM 1: In anterior cervical decompression and fusion (ACDF) subjects, explore the association between prebiotics, anxiety, and pain. Studies have recently elucidated a link between certain prebiotics and lower perceived anxiety as well as biomarkers of stress. In this aim the investigators will explore the association between consumption of prebiotics and their relationship to perioperative anxiety / physiological stress response. The investigators hypothesize that subjects who receive prebiotics will have lower perioperative anxiety and stress versus control as measured by standardized surveys and biomarkers. Furthermore, the investigators hypothesize that lower anxiety will result in lower postoperative pain scores. AIM 2: In ACDF patients, explore the association between GOS and post-operative cognitive dysfunction. Stress and anxiety is known to impair cognitive function. In addition, in preclinical studies, the administration of distinct keystone bacterial strains improves cognitive function in an anxious mouse model. In humans, prebiotics and probiotics have been shown to ameliorate the stress response. In this aim the investigators seek to explore the association between prebiotics and perioperative cognitive outcomes in humans. The investigators will perform cognitive function testing using the same time-tested battery used in the department to study post-operative cognitive decline (POCD). Subjects will be tested for cognitive function preoperatively (T1) and at 1.5 months post-op (T4). The investigators hypothesize that patients receiving prebiotics during the perioperative period will show less post-operative cognitive dysfunction than controls. A total of 8 subjects will be recruited from the Neurosurgery Clinics of Duke University Health System. The target population will include subjects undergoing ACDF. Exclusion criteria will include: pregnant women, age\<21 years, a diagnosis of depression, mental or behavioral disorder, recent anxiolytic use, long-term opiate use, oral contraceptive use, or recent antibiotic use.
Interventions
Mixture produced from lactose utilizing the transgalactosidic activity of Bifidobacterium bifidum NCIMB 41171 beta-galactosidase
DRUGMaltodextrin (Placebo)
Maltodextrin is a polysaccharide commonly used as a food additive. It is produced from starch by partial hydrolysis.
Sponsors
Jeff Taekman, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing anterior cervical discectomy and fusion
Exclusion criteria
* Pregnancy * Breast Feeding Women * Diagnosis of Depression * Diagnosis of mental or behavioral disorder * Recent anxiolytic use (within 1 week of enrollment) * Long-term opiate use (greater than 1 week prior to enrollment) * Recent systemic steroid use (within 1 week of enrollment) * Diagnosis of cancer * Oral or intravenous antibiotic use within 1 month of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Waking Salivary Cortisol | Morning after Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6-week follow-up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pain perception | Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 30 minutes after surgery, 1-day after surgery, 6 week follow-up visit | Collected through Visual Analog Scale. |
| Changes in cognition | Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit | Hopkins Verbal Learning Test - Revised (HVLT-R) |
| Changes in perceived stress | Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit | Subjects will complete web-based versions of the State-Trait Anxiety Scale. |
| Suicidal ideation and behavior | Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit | Columbia-Suicide Severity Rating Scale (C-SSRS) |
Countries
United States
Outcome results
None listed