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

NCT04461093 | Completed

• 1 other identifier: PalanosetronUSM
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Palonosetron

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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.

Study Arms (2)

Group I

EXPERIMENTAL

Group I (n=45) 1. Acupressure wristband 2. IV Dexamethasone 8mg 3. IV Ondansetron 4mg

Other: Acupressure wristband and Palanosetron

Group II

ACTIVE COMPARATOR

Group II (n=45) 1\. IV Palonosetron 0.075mg

Other: Acupressure wristband and Palanosetron

Interventions

Acupressure wristband and Palanosetron 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 I; Group II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I or II female patients aged 18 - 65 years old in view female patients are at higher risk of postoperative nausea and vomiting.
• Patients undergoing laparoscopic surgery.
• High risk for PONV (APFEL score 3-4).

You may not qualify if:

• Patients with known allergic to dexamethasone, ondansetron and wristband.
• Patients who take anti-emetic, emetogenic drugs and glucocorticoids within 24 hours before surgery.
• Patients with upper limb disability which affect the application of wristband.
• 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.
• Pre-existing vertigo

Sponsors & Collaborators

• Mohd Zulfakar Mazlan, MBBS: lead

Study Sites (2)

Mohd Zulfakar Mazlan, MBBS

Kota Bharu, Kelantan, 16150, Malaysia

Location

Mohd Zulfakar Mazlan

Kota Bharu, Kelantan, 16150, Malaysia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Potential patients are identified and consented for study during pre-operative assessment. Both patients and assessors are blinded in this trial. Participants and assessors are being blinded of the treatment or medications given intra-operatively. The acupressure wristband and anti-emetics will be given after general anaesthesia. The wristband will be removed prior to emergence, participants will not aware of the methods used to prevent nausea and vomiting. Postoperative participants will be assessed by independent nurses who are not involved in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Comparison of the efficacy of acupressure P6 point, dexamethasone and ondansetron versus palonosetron monotherapy for preventing postoperative nausea and vomiting in laparoscopic surgery

Model Details: Double blinded, Randomized Controlled Trial

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: July 8, 2020
• Study Start: July 6, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)