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

Primary Purpose

Palonosetron

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Acupressure wristband and Palanosetron
Sponsored by
Mohd Zulfakar Mazlan, MBBS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Palonosetron

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mohd Zulfakar Mazlan, MBBS
  • Mohd Zulfakar MazlanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I

Group II

Arm Description

Group I (n=45) Acupressure wristband IV Dexamethasone 8mg IV Ondansetron 4mg

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

Outcomes

Primary Outcome Measures

The incidence of postoperative nausea and vomiting immediately, at
The incidence of postoperative nausea and vomiting immediately, at
The incidence of postoperative nausea and vomiting immediately, at
The incidence of postoperative nausea and vomiting immediately, at

Secondary Outcome Measures

The proportion of patients require rescue anti-emetics immediately,
The proportion of patients require rescue anti-emetics immediately,
The proportion of patients require rescue anti-emetics immediately,
The proportion of patients require rescue anti-emetics immediately,

Full Information

First Posted
April 15, 2020
Last Updated
July 13, 2020
Sponsor
Mohd Zulfakar Mazlan, MBBS
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1. Study Identification

Unique Protocol Identification Number
NCT04461093
Brief Title
Comparison of the Efficacy of Acupressure P6 Point, Dexamethasone and Ondansetron Versus Palonosetron Monotherapy for Preventing Postoperative Nausea and Vomiting in Laparoscopic Surgery
Official Title
Comparison of the Efficacy of Acupressure P6 Point, Dexamethasone and Ondansetron Versus Palonosetron Monotherapy for Preventing Postoperative Nausea and Vomiting in Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohd Zulfakar Mazlan, MBBS

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palonosetron

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded, Randomized Controlled Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
Group I (n=45) Acupressure wristband IV Dexamethasone 8mg IV Ondansetron 4mg
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Group II (n=45) 1. IV Palonosetron 0.075mg
Intervention Type
Other
Intervention Name(s)
Acupressure wristband and Palanosetron
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of postoperative nausea and vomiting immediately, at
Time Frame
Hours 6, postoperative.
Title
The incidence of postoperative nausea and vomiting immediately, at
Time Frame
Hours 12, postoperative
Title
The incidence of postoperative nausea and vomiting immediately, at
Time Frame
Hours 24, postoperative
Title
The incidence of postoperative nausea and vomiting immediately, at
Time Frame
Hours 48, postoperative
Secondary Outcome Measure Information:
Title
The proportion of patients require rescue anti-emetics immediately,
Time Frame
at Hours 6, postoperative.
Title
The proportion of patients require rescue anti-emetics immediately,
Time Frame
Hours 12, postoperative.
Title
The proportion of patients require rescue anti-emetics immediately,
Time Frame
Hours 24, postoperative.
Title
The proportion of patients require rescue anti-emetics immediately,
Time Frame
Hours 48, postoperative.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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
Facility Information:
Facility Name
Mohd Zulfakar Mazlan, MBBS
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohd Zulfakar Mazlan, MBBS
Phone
+6097673000
Ext
6104
Email
zulfakar@usm.my
Phone
+60129091447
First Name & Middle Initial & Last Name & Degree
Woei Zhong Chiong, MBBS
Facility Name
Mohd Zulfakar Mazlan
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohd Zulfakar Mazlan, MBBS
Phone
+60129091447
Ext
6104
Email
zulfakar@usm.my
First Name & Middle Initial & Last Name & Degree
Zhong Woei Chiong, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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