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The efficacy of the EmeTerm bracelet in preventing postoperative nausea and vomiting

Risk of postoperative nausea and vomiting after total hip or knee arthroplasty under spinal anesthesia: randomized trial comparing conventional anti-emetics with or without EmeTerm® bracelet

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN60848297
Enrollment
140
Registered
2023-11-12
Start date
2023-11-20
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of postoperative nausea and vomiting in patients with total joint arthroplasty under spinal anesthesia Signs and Symptoms

Interventions

Current interventions as of 21/10/2024: Randomization: To enhance the baseline comparability, THA and TKA have been chosen as stratification factors. A researcher who is not involved in subsequent s

Sponsors

Luoyang Orthopedic-Traumatological Hospital of Henan Province
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 21/10/2024: Patients at our hospital were eligible for enrollment if they (1) were scheduled for primary unilateral THA or TKA under spinal anesthesia between November 2023 and April 2024 to treat osteoarthritis or other joint diseases at an advanced stage; (2) were between 18 and 75 years old; and (3) scored 2 (moderate risk) or 3-4 (high risk) for PONV on Apfel scale _____ Previous inclusion criteria: Patients aged 18-75 who require unilateral and initial total joint arthroplasty due to hip or knee joint disease.

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 21/10/2024: 1. Were allergic to metal or study medications 2. Had a pacemaker, implantable glucose monitor, or cochlear implant 3. Had taken anti-emetics or systemic steroids within the previous week 4. Had diabetes and did not show adequate control of blood glucose 5. Suffered severe dysfunction of the heart, kidneys, or liver _____ Previous exclusion criteria: 1. Cardiac pacemakers, blood glucose meters, or cochlear implants 2. Epilepsy 3. Metal contact allergies 4. Nausea and vomiting within one week before admission 5. Any surgery within one month prior to admission

Design outcomes

Secondary

MeasureTime frame
Current secondary outcome measures as of 21/10/2024: 1. The rates within 24 h postoperatively: complete response of PONV and severe PONV 2. The rate of PONV during different postoperative intervals (0-3 h, 3-6 h, 6-12 h, 12-24 h) 3. The rate of metoclopramide rescue within 24 h postoperatively 4. The rate of bracelet-related adverse events, defined as local allergic reactions on the skin 5. The quality of recovery at 24 and 48 h postoperatively using the 40-item Quality of Recovery (QOR-40) instrument _____ Previous secondary outcome measures: 1. The usage rate and dosage of postoperative nausea and vomiting remedies measured using patient records 24 hours after surgery 2. The incidence of equipment-related complications measured using patient records 24 hours after surgery

Primary

MeasureTime frame
Current primary outcome measure as of 21/10/2024: 1. The incidence of PONV within 24 h postoperatively _____ Previous primary outcome measure: 1. The total number and frequency of patients experiencing nausea and vomiting measured using patient records 24 hours after surgery 2. Number and frequency of patients experiencing nausea and vomiting measured using patient records at 0-3, 3-12, and 12-24 hours after surgery 3. The severity of nausea and vomiting measured using patient records 24 hours after surgery

Countries

China

Contacts

Public ContactYi dan Yang
709925524@qq.com+86 17839954318

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026