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Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

Primary Purpose

Post Operative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Peppermint essential oil
Granisetron
Dexamethasone
Sponsored by
Universiti Kebangsaan Malaysia Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Nausea and Vomiting focused on measuring peppermint oil, intrathecal morphine, PONV, lower segment cesarean section, dexamethasone, granisetron

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Universiti Kebangsaan Malaysia Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Granisetron & Dexamethasone & Peppermint essential oil

Granisetron & Dexamethasone

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2018
Last Updated
April 16, 2019
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03434340
Brief Title
Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting
Official Title
Aromatherapy as Prophylaxis for Prevention of Intrathecal Morphine Induced Nausea and Vomiting in Lower Segment Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
April 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Nausea and Vomiting
Keywords
peppermint oil, intrathecal morphine, PONV, lower segment cesarean section, dexamethasone, granisetron

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Granisetron & Dexamethasone & Peppermint essential oil
Arm Type
Experimental
Arm 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
Arm Title
Granisetron & Dexamethasone
Arm Type
Active Comparator
Arm Description
Granisetron 1mg and Dexamethasone 4mg administer as intravenous injection once right after delivery of newborn
Intervention Type
Biological
Intervention Name(s)
Peppermint essential oil
Other Intervention Name(s)
YoungLiving®, 100% pure Peppermint essential oil
Intervention Description
2 drops applied on a nasal strip
Intervention Type
Drug
Intervention Name(s)
Granisetron
Intervention Description
1mg intravenous injection
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
4mg intravenous injection
Primary Outcome Measure Information:
Title
Severity of nausea and vomiting
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assoc Prof Dr Raha Abdul Rahman
Organizational Affiliation
Consultant Anaesthesiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Kebangsaan Malaysia Medical Centre
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19803313
Citation
Ravindran J. Rising caesarean section rates in public hospitals in Malaysia 2006. Med J Malaysia. 2008 Dec;63(5):434-5.
Results Reference
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PubMed Identifier
22513952
Citation
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.
Results Reference
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PubMed Identifier
26734609
Citation
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.
Results Reference
background
PubMed Identifier
24565347
Citation
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.
Results Reference
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PubMed Identifier
22344239
Citation
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.
Results Reference
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PubMed Identifier
19462494
Citation
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.
Results Reference
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PubMed Identifier
24356162
Citation
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.
Results Reference
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PubMed Identifier
26744729
Citation
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.
Results Reference
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PubMed Identifier
10962794
Citation
Cooke B, Ernst E. Aromatherapy: a systematic review. Br J Gen Pract. 2000 Jun;50(455):493-6.
Results Reference
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PubMed Identifier
34002866
Citation
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.
Results Reference
derived

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Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

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