Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT03434340

Recruitment Status : Completed

First Posted : February 15, 2018

Last Update Posted : April 18, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Universiti Kebangsaan Malaysia Medical Centre

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
Post Operative Nausea and Vomiting	Biological: Peppermint essential oil Drug: Granisetron Drug: Dexamethasone	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
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 :	June 26, 2018
Actual Primary Completion Date :	March 22, 2019
Actual Study Completion Date :	April 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate Granisetron

U.S. FDA Resources

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 Name: 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 :

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.

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434340

Locations

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

Sponsors and Collaborators

Universiti Kebangsaan Malaysia Medical Centre

Investigators

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Principal Investigator:	Assoc Prof Dr Raha Abdul Rahman	Consultant Anaesthesiologist

More Information

Publications:

Ravindran J. Rising caesarean section rates in public hospitals in Malaysia 2006. Med J Malaysia. 2008 Dec;63(5):434-5.

Hines S, Steels E, Chang A, Gibbons K. Aromatherapy for treatment of postoperative nausea and vomiting. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD007598. doi: 10.1002/14651858.CD007598.pub2.

Stoicea N, Gan TJ, Joseph N, Uribe A, Pandya J, Dalal R, Bergese SD. Alternative Therapies for the Prevention of Postoperative Nausea and Vomiting. Front Med (Lausanne). 2015 Dec 16;2:87. doi: 10.3389/fmed.2015.00087. eCollection 2015.

Carvalho FA, Tenorio SB. Comparative study between doses of intrathecal morphine for analgesia after caesarean. Braz J Anesthesiol. 2013 Nov-Dec;63(6):492-9. doi: 10.1016/j.bjane.2013.01.001. Epub 2013 Dec 5.

Allen TK, Jones CA, Habib AS. Dexamethasone for the prophylaxis of postoperative nausea and vomiting associated with neuraxial morphine administration: a systematic review and meta-analysis. Anesth Analg. 2012 Apr;114(4):813-22. doi: 10.1213/ANE.0b013e318247f628. Epub 2012 Feb 17.

Gehling M, Tryba M. Risks and side-effects of intrathecal morphine combined with spinal anaesthesia: a meta-analysis. Anaesthesia. 2009 Jun;64(6):643-51. doi: 10.1111/j.1365-2044.2008.05817.x.

Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494.

Shanazi M, Farshbaf Khalili A, Kamalifard M, Asghari Jafarabadi M, Masoudin K, Esmaeli F. Comparison of the Effects of Lanolin, Peppermint, and Dexpanthenol Creams on Treatment of Traumatic Nipples in Breastfeeding Mothers. J Caring Sci. 2015 Dec 1;4(4):297-307. doi: 10.15171/jcs.2015.030. eCollection 2015 Dec.

Cooke B, Ernst E. Aromatherapy: a systematic review. Br J Gen Pract. 2000 Jun;50(455):493-6.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.

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Responsible Party:	Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier:	NCT03434340
Other Study ID Numbers:	2017461
First Posted:	February 15, 2018 Key Record Dates
Last Update Posted:	April 18, 2019
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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:


peppermint oil intrathecal morphine PONV	lower segment cesarean section dexamethasone granisetron

Additional relevant MeSH terms:

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Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Postoperative Complications Pathologic Processes Dexamethasone Granisetron Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Serotonin 5-HT3 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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