Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT03187535
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients , 18 or older
* American Society of Anesthesiologists (ASA) classification I or II or III
* Undergoing elective spinal surgery expected to last no more than four hours (from induction of anesthesia to extubation).
* Capable and willing to consent
Exclusion Criteria:
* Neuraxial (intrathecal or epidural) block
* Significant ongoing history of vestibular disease or dizziness
* Nausea or vomiting within 24 hours prior to surgery, use of antiemetic or emetogenic drugs within 3 days of surgery
* Documented alcohol or substance abuse within 3 months before the surgery
* Limb abnormalities such as burn and amputation.
* Poorly controlled diabetes mellitus (fasting plasma glucose \>126 mg/dL or \<70 mg/dL)
* Implantation of metal/electrical devices, such as nerve stimulator, cardiac pacemaker, cardioverter, defibrillator and internal hearing aids
* Rash, local infection, keloid, any dermatologic condition that could interfere with the acupoint stimulation area
* Documented alcohol or substance abuse within 3 months before surgery
* Presence of clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, or schizophrenia
* Chemotherapy or radiation therapy within 7 days before surgery
* Investigational product use within 3 months prior surgery
* Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study (history of unstable cardiovascular, pulmonary, renal, hepatic, seizures)
* Special population (prisoners, pregnant and lactating women)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03187535
Study Brief:
Protocol Section:
NCT03187535