Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

Sponsor
Universiti Kebangsaan Malaysia Medical Centre (Other)
Overall Status
Completed
CT.gov ID
NCT03434340
Collaborator
(none)
155
1
2
9.2
16.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
155 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Aromatherapy as Prophylaxis for Prevention of Intrathecal Morphine Induced Nausea and Vomiting in Lower Segment Cesarean Section
Actual Study Start Date :
Jun 26, 2018
Actual Primary Completion Date :
Mar 22, 2019
Actual Study Completion Date :
Apr 2, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Severity of nausea and vomiting [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universiti Kebangsaan Malaysia Medical Centre Cheras Kuala Lumpur Malaysia 56000

    Sponsors and Collaborators

    • Universiti Kebangsaan Malaysia Medical Centre

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Universiti Kebangsaan Malaysia Medical Centre
    ClinicalTrials.gov Identifier:
    NCT03434340
    Other Study ID Numbers:
    • 2017461
    First Posted:
    Feb 15, 2018
    Last Update Posted:
    Apr 18, 2019
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Universiti Kebangsaan Malaysia Medical Centre
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 18, 2019