Effect of Acupuncture on Postoperative Nausea and Vomiting

NCT ID: NCT06669676

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-07
• Study Completion Date: 2025-03-15

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.

Detailed Description

The study will include patients aged 18 years and over, with (American Society of Anesthesiologists) ASA physical status I to II, and scheduled for one or two-level lumbar disc herniation surgery under general anesthesia. Patient characteristics (age, gender, body mass index, etc.) and postoperative nausea and vomiting (PONV) risk factors such as history of PONV, motion sickness, and history of not smoking will be recorded. The primary outcome parameter will be the incidence of PONV within 24 hours postoperatively. The severity of nausea in patients who develop nausea in the postoperative period will be assessed using a Likert scale between 0 and 10. PONV will be defined as vomiting, significant nausea (numerical rating scale [NRS] ≥4), and/or need for rescue medication. Patients will be assessed for PONV at 0, 2, 4, 12, and 24 hours using a Likert scale. Emetic attacks, pain and severity of pain, nausea and severity of nausea, need for additional analgesics, and administration of antiemetic rescue medication will be assessed as secondary outcome parameters. The severity of pain and nausea in patients who develop postoperative pain will be assessed using an 11-point numerical rating scale, where '0' indicates the absence of symptoms and '10' indicates the maximum severity. PONV within the first two hours will be defined as 'early', and within 2-24 hours after awakening will be defined as 'late'. Nausea will be defined as the desire to vomit, and vomiting will be defined as the forceful expulsion of stomach contents.

Conditions

Anesthesia; Nausea and Vomiting, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Acupuncture

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

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: OTHER

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

No Acupuncture

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

Group Type: ACTIVE_COMPARATOR

No acupuncture

Intervention Type: OTHER

patients will be given standard medical treatment to prevent ponv

Interventions

acupuncture

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

Intervention Type: OTHER

No acupuncture

patients will be given standard medical treatment to prevent ponv

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• patients in a condition where cooperation cannot be established in the post-operative period (mental retardation etc.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Gökhan Erdem

Anesthesiology and Reanimation specialist doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

PONV

Identifier Type: -

Identifier Source: org_study_id