Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Operative Nausea and Vomiting

Intervention / Treatment
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* Biological: Peppermint essential oil
* Drug: Granisetron
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Granisetron & Dexamethasone & Peppermint essential oil<br>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<br>* 2 drops applied on a nasal strip<br>* Other names: YoungLiving®, 100% pure Peppermint essential oil;Drug: Granisetron<br>* 1mg intravenous injection<br>Drug: Dexamethasone<br>* 4mg intravenous injection<br>|
| Active Comparator: Granisetron & Dexamethasone<br>Granisetron 1mg and Dexamethasone 4mg administer as intravenous injection once right after delivery of newborn | Drug: Granisetron<br>* 1mg intravenous injection<br>Drug: Dexamethasone<br>* 4mg intravenous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of nausea and vomiting | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PONV, peppermint oil, intrathecal morphine, lower segment cesarean section, dexamethasone, granisetron