Comparison of the Efficacy of Acupressure P6 Point, Dexamethasone and Ondansetron Versus Palonosetron Monotherapy for Preventing Postoperative Nausea and Vomiting in Laparoscopic Surgery

NCT ID: NCT04461093

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-06
• Study Completion Date: 2021-11-01

Brief Summary

Postoperative nausea and vomiting (PONV) is defined as nausea and/or vomiting occurring within 24 hours after surgery, it commonly affects 20-30% patients but as high as 70-80% patients who are deemed high risk for PONV may be affected. PONV may cause unpleasant complications such as dehydration, electrolyte imbalance, suture dehiscence, aspiration of gastric contents, delayed recovery and prolonged hospital stay. Standard guideline recommended combination of anti-emetics to prevent PONV in high risk patients. The commonly used agents are dexamethasone and ondansetron which are cheaper although they are proven to be less effective as single agent when compared with newer agent such as palonosetron. As an adjunct or alternative to pharmacological treatment, acupressure P6 point has gained increasing attention for its possible value in preventing PONV. It is proven that acupressure reduced the incidences of PONV when combined with pharmacological treatment. It is postulated that acupressure active Aβ and Aδ fibres and stimulate the release of β-endorphine from hypothalamus. In addition, it is believed that acupressure might act on dopaminergic, serotonergic and norepinerphrinergic fibres which might has a role in PONV prevention.

Detailed Description

This study is designed to compare the efficacy of palonosetron monotherapy versus combination of acupressure P6 point with dexamethasone and ondansetron in preventing PONV. It has been proven that palonosetron is more superior as single agent when compared with acupressure, dexamethasone and ondansetron separately. However, this might not be cost effective as palonosetron is more expensive than the other agents. In addition, the combination therapy has been reported better in preventing PONV when compared with monotherapy. The investigators need to investigate whether the combination of acupressure with dexamethasone and ondansetron exert an effect equal or even better than palonosetron monotherapy. The investigators hypothesis is the combination of acupressure P6 point with dexamethasone and ondansetron provide better prophylaxis againts PONV when compared with palonosetron. The requirement for rescue anti-emetics for combination of acupressure P6 point with dexamethasone and ondansetron group is lesser than palonosetron.

Conditions

Palonosetron

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group I

Group I (n=45)

1. Acupressure wristband

2. IV Dexamethasone 8mg

3. IV Ondansetron 4mg

Group Type: EXPERIMENTAL

Acupressure wristband and Palanosetron

Intervention Type: OTHER

Group 1 Patients with odd numbers labelled form will be Group I patients. They will receive intravenous dexamethasone 8mg during induction. Acupressure P6 wristband is applied after induction and removed prior to emergence to maintain blinding. Intravenous ondansetron 4mg is given prior to skin closure.

Group 11 Patients with even numbers labelled form will be Group II patients who will receive intravenous palonosetron 0.075mg during induction.

Group II

Group II (n=45)

1. IV Palonosetron 0.075mg

Group Type: ACTIVE_COMPARATOR

Acupressure wristband and Palanosetron

Intervention Type: OTHER

Group 1 Patients with odd numbers labelled form will be Group I patients. They will receive intravenous dexamethasone 8mg during induction. Acupressure P6 wristband is applied after induction and removed prior to emergence to maintain blinding. Intravenous ondansetron 4mg is given prior to skin closure.

Group 11 Patients with even numbers labelled form will be Group II patients who will receive intravenous palonosetron 0.075mg during induction.

Interventions

Acupressure wristband and Palanosetron

Group 1 Patients with odd numbers labelled form will be Group I patients. They will receive intravenous dexamethasone 8mg during induction. Acupressure P6 wristband is applied after induction and removed prior to emergence to maintain blinding. Intravenous ondansetron 4mg is given prior to skin closure.

Group 11 Patients with even numbers labelled form will be Group II patients who will receive intravenous palonosetron 0.075mg during induction.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. ASA I or II female patients aged 18 - 65 years old in view female patients are at higher risk of postoperative nausea and vomiting.

2. Patients undergoing laparoscopic surgery.

3. High risk for PONV (APFEL score 3-4).

Exclusion Criteria

1. Patients with known allergic to dexamethasone, ondansetron and wristband.

2. Patients who take anti-emetic, emetogenic drugs and glucocorticoids within 24 hours before surgery.

3. Patients with upper limb disability which affect the application of wristband.

4. Obese patients with BMI > 35 in view acupressure P6 wristband might be too tight to fit patient's wrist which might affect the correct placement of pressure point.

5. Pre-existing vertigo

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mohd Zulfakar Mazlan, MBBS

OTHER

Sponsor Role: lead

Responsible Party

Mohd Zulfakar Mazlan, MBBS

Comparison of the efficacy of acupressure P6 point, dexamethasone and ondansetron versus palonosetron monotherapy for preventing postoperative nausea and vomiting in laparoscopic surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mohd Zulfakar Mazlan, MBBS

Kota Bharu, Kelantan, Malaysia

Mohd Zulfakar Mazlan

Kota Bharu, Kelantan, Malaysia

Countries

Malaysia

Other Identifiers

PalanosetronUSM

Identifier Type: -

Identifier Source: org_study_id