This phase II/III compares the effect of hypnosedation to general anesthesia during breast cancer surgery in lowering anxiety and pain levels for patients with stage 0-1 breast cancer. Surgery is a necessary treatment for breast cancer, but patients may experience side effects from the general anesthesia and opioids given during and after surgery. Hypnosedation is an alternative to general anesthesia that places patients under conscious sedation where they remain awake and numbed during surgery. It involves the use of words and images to help patients relax and to affect their thoughts about what is happening during surgery. This trial may help researchers determine how effective hypnosedation alone is before and during surgery in reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05766891.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Lorenzo Cohen
Phone: 713-745-4260
PRIMARY OBJECTIVE:
I. To determine the efficacy of hypnosedation (HS) provided by a nurse anesthetist before and during surgery versus HS-general anesthesia (GA) or GA on reducing morphine equivalent daily dose (MEDD) from day of surgery through post-operative day (POD) 14.
SECONDARY OBJECTIVES:
I. To determine the efficacy of HS with local anesthesia versus (vs) HS-GA or GA on reducing self-reported and objective pain, anxiety, nausea/vomiting, fatigue, and cognitive dysfunction.
II. To evaluate group differences in costs. Using time and motion studies and methods of economic evaluation, we will test the hypothesis that HS before and during surgery will lead to less time spent in the operating room (OR) and post anesthesia care unit (PACU), lower medication use, and less need for clinical staff engagement, leading to lower overall day of surgery-related costs.
III. To explore psychosocial factors as moderators of the effects of the intervention and predictors of recovery.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients undergo hypnosedation before and during surgery and local anesthesia during surgery.
GROUP II: Patients undergo hypnosedation before surgery and general anesthesia during surgery.
GROUP III: Patients undergo general anesthesia during surgery.
Trial PhasePhase II/III
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorLorenzo Cohen
