Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

National University of Malaysia (UKM)

Status: Completed

Conditions: Post Operative Nausea and Vomiting

Treatments: Biological: Peppermint essential oil; Drug: Granisetron; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03434340

2017461

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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155 participants in 2 patient groups

Granisetron & Dexamethasone & Peppermint essential oil

Experimental group

Description:

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

Treatment:

Drug: Granisetron

Drug: Dexamethasone

Biological: Peppermint essential oil

Granisetron & Dexamethasone

Active Comparator group

Description:

Granisetron 1mg and Dexamethasone 4mg administer as intravenous injection once right after delivery of newborn

Treatment:

Drug: Granisetron

Drug: Dexamethasone