Effect of Acupuncture on Postoperative Nausea and Vomiting

NCT06669676 | Completed

• 1 other identifier: PONV
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the hypothesis that bilateral acupuncture needling at the Neiguan (PC6) point during the intraoperative period, in addition to the 0.15 mg/kg dose of ondansetron (5-HT3 antagonist) frequently used for postoperative nausea and vomiting (PONV) prophylaxis in patients undergoing lumbar disc herniation surgery, would reduce the incidence of PONV was investigated. PONV was defined as the presence of nausea and vomiting within 24 hours postoperatively.

Conditions

Anesthesia; Nausea and Vomiting, Postoperative

Keywords

acupuncture; postoperative nausea vomiting; apfel score

Outcome Measures

Primary Outcomes (1)

• PONV

  The primary outcome of the study was the incidence of postoperative nausea and/or vomiting

  24 hours

Secondary Outcomes (3)

• Severity of nausea

  24 hours

• 11 - point numerical rating scale (NRS)

  24 hours

• Rescue emetic requirement

  24 hours

Study Arms (2)

Acupuncture

ACTIVE COMPARATOR

patients will be given acupuncture in addition to standard medical treatment to prevent ponv

Other: acupuncture

No Acupuncture

ACTIVE COMPARATOR

patients will be given acupuncture in addition to standard medical treatment to prevent ponv

Other: No acupuncture

Interventions

acupuncture OTHER

patients will be given acupuncture in addition to standard medical treatment to prevent ponv

Acupuncture

No acupuncture OTHER

patients will be given standard medical treatment to prevent ponv

No Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above
• ASA physical status I to II
• One or two level lumbar disc herniation surgery under general anesthesia

You may not qualify if:

• body mass index \>35 kg/m²)
• history of drug use
• nausea and vomiting before surgery
• psychiatric disorders
• use of antipsychotic or antiemetic drugs
• severe heart disease
• central nervous system diseases
• vertebrobasilar artery insufficiency
• cytostatic therapy
• vestibular diseases
• renal and/or hepatic dysfunction
• presence of fistula, neuropathy and paralysis in the extremity to be treated
• patient's refusal to accept acupuncture
• pregnant patients
• presence of bleeding diathesis

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation specialist doctor

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: November 7, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 15, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)