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Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
RECRUITINGPhase 2/3Sponsored by M.D. Anderson Cancer Center
Actively Recruiting
PhasePhase 2/3
SponsorM.D. Anderson Cancer Center
Started2023-10-12
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05766891
Summary
To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: 1. Men and Women; 2. Age 18 or older; 3. Diagnosed with stage 0/1 BCa; 4. Scheduled for a unilateral, segmental mastectomy, including excisional biopsy, ± SLND 5. Able to read, write and speak English or Spanish 6. Able to sign a written informed consent and be willing to follow protocol requirements. Exclusion Criteria: 1. Extreme mobility issues that preclude participating in the study 2. Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or PTSD 3. History of chronic opioid use 4. Current pain 2 or above on 0-10 scale 5. Co-mobilities such as uncontrollable diabetes or hypertension 6. Plastic surgery involvement for oncoplastic reconstruction 7. Have undergone chemotherapy for current breast cancer diagnosis 8. Surgery is likely greater than 3 hours 9. Patients with hearing loss that could preclude HS facilitation 10. Known allergy to propofol or other medications used during surgery
Conditions2
Breast CancerCancer
Locations1 site
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Actively Recruiting
PhasePhase 2/3
SponsorM.D. Anderson Cancer Center
Started2023-10-12
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05766891