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

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.

Study Overview

• Status: Unknown
• Conditions: Palonosetron
• Intervention / Treatment: Other: Acupressure wristband and Palanosetron

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 16150
      • Not yet recruiting
      • Mohd Zulfakar Mazlan, MBBS
      • Contact: Mohd Zulfakar Mazlan, MBBS; Phone Number: 6104 +6097673000; Email: zulfakar@usm.my
      • Contact: Phone Number: +60129091447
      • Principal Investigator: Woei Zhong Chiong, MBBS
    • Kota Bharu, Kelantan, Malaysia, 16150
      • Recruiting
      • Mohd Zulfakar Mazlan
      • Contact: Mohd Zulfakar Mazlan, MBBS; Phone Number: 6104 +60129091447; Email: zulfakar@usm.my
      • Principal Investigator: Zhong Woei Chiong, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Group I (n=45); Acupressure wristband; IV Dexamethasone 8mg; IV Ondansetron 4mg	Other: 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.
Active Comparator: Group II; Group II (n=45) 1. IV Palonosetron 0.075mg	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of postoperative nausea and vomiting immediately, at	Hours 6, postoperative.
The incidence of postoperative nausea and vomiting immediately, at	Hours 12, postoperative
The incidence of postoperative nausea and vomiting immediately, at	Hours 24, postoperative
The incidence of postoperative nausea and vomiting immediately, at	Hours 48, postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients require rescue anti-emetics immediately,	at Hours 6, postoperative.
The proportion of patients require rescue anti-emetics immediately,	Hours 12, postoperative.
The proportion of patients require rescue anti-emetics immediately,	Hours 24, postoperative.
The proportion of patients require rescue anti-emetics immediately,	Hours 48, postoperative.

Collaborators and Investigators

• Sponsor: Mohd Zulfakar Mazlan, MBBS

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: PalanosetronUSM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No