Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

April 16, 2019 updated by: Universiti Kebangsaan Malaysia Medical Centre

Aromatherapy as Prophylaxis for Prevention of Intrathecal Morphine Induced Nausea and Vomiting in Lower Segment Cesarean Section

This study evaluates the effect of combining non pharmacological anti emetic prophylaxis, namely peppermint essential oil to granisetron and dexamethasone in patient who receive intrathecal morphine for lower segment cesarean section. Half of the patient will receive nasal strip containing peppermint essential oil in addition to granisetron and dexamethasone while the other half will only receive granisetron and dexamethasone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is not uncommon to use different group of anti emetic in order to achieve high successful rate in the prevention of opioid induced nausea and vomiting. This study evaluates the effect of combining non pharmacological and pharmacological method to prevent such condition.

Aromatherapy has been used since many years to treat nausea and vomiting. One of the proposed mechanism is by the activation of olfactory receptor when the molecules of essential oil absorb in the mucus lining olfactory epithelium. The signal is then carried by olfactory sensory neuron to the olfactory bulb which filters and send signal to olfactory cortex as well as limbic system to give the feeling of well being.

Granisetron is a serotonin 3 receptor antagonist prevent or treat nausea and vomiting by competitively blocks the action of serotonin at 5-hydroxytryptamine 3 (5HT3) receptors while the mechanism of action of dexamethasone; which is a glucocorticoids is not fully understood.

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Universiti Kebangsaan Malaysia Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) I and II.
  • Non-smoker.
  • BMI =< 40
  • Singleton pregnancy

Exclusion Criteria:

  • Patient with known allergy to granisetron, dexamethasone, bupivacaine, fentanyl, morphine, paracetamol, celecoxib, ginger oil.
  • Patient who has inability to breathe through nose.
  • Patient with history of post-operative nausea and vomiting (PONV) or motion sickness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Granisetron & Dexamethasone & Peppermint essential oil
Granisetron 1mg and Dexamethasone 4mg administer as intravenous injection once right after delivery of newborn followed by Peppermint essential oil 2 drops on nasal strip applied for 6 hours
Biological: Peppermint essential oil
2 drops applied on a nasal strip
Other Names:
  • YoungLiving®, 100% pure Peppermint essential oil
Drug: Granisetron
1mg intravenous injection
Drug: Dexamethasone
4mg intravenous injection
ACTIVE_COMPARATOR: Granisetron & Dexamethasone
Granisetron 1mg and Dexamethasone 4mg administer as intravenous injection once right after delivery of newborn
Drug: Granisetron
1mg intravenous injection
Drug: Dexamethasone
4mg intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of nausea and vomiting
Time Frame: 24 hours
Severity of nausea and vomiting is assessed by direct questioning or spontaneous complaint by patient at three time interval; after institution of spinal anesthesia until prior to being discharged from recovery bay, at 6 hour and 24 hour for 1 day. For nausea, severity is assessed using numerical rating scale (NRS). 0 means no nausea while 10 means worst imaginable nausea. As for vomiting, number of occurrence indicates severity. 1-2 times is considered mild, 3-5 times is moderate and more than 5 times is severe.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Investigators

  • Principal Investigator: Assoc Prof Dr Raha Abdul Rahman, Consultant Anaesthesiologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 26, 2018

Primary Completion (ACTUAL)

March 22, 2019

Study Completion (ACTUAL)

April 2, 2019

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (ACTUAL)

February 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017461

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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