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Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

Not Applicable
Completed
Conditions
Post Operative Nausea and Vomiting
Interventions
Biological: Peppermint essential oil
Drug: Granisetron
Drug: Dexamethasone
Registration Number
NCT03434340
Lead Sponsor
Universiti Kebangsaan Malaysia Medical Centre
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
155
Inclusion Criteria
  • American Society of Anesthesiologists (ASA) I and II.
  • Non-smoker.
  • BMI =< 40
  • Singleton pregnancy
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Granisetron & Dexamethasone & Peppermint essential oilDexamethasoneGranisetron 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
Granisetron & DexamethasoneDexamethasoneGranisetron 1mg and Dexamethasone 4mg administer as intravenous injection once right after delivery of newborn
Granisetron & Dexamethasone & Peppermint essential oilPeppermint essential oilGranisetron 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
Granisetron & Dexamethasone & Peppermint essential oilGranisetronGranisetron 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
Granisetron & DexamethasoneGranisetronGranisetron 1mg and Dexamethasone 4mg administer as intravenous injection once right after delivery of newborn
Primary Outcome Measures
NameTimeMethod
Severity of nausea and vomiting24 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Universiti Kebangsaan Malaysia Medical Centre

🇲🇾

Cheras, Kuala Lumpur, Malaysia

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