Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

NCT03434340 | Completed DMC

• 1 other identifier: 2017461
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Nausea and Vomiting

Keywords

peppermint oil; intrathecal morphine; PONV; lower segment cesarean section; dexamethasone; granisetron

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Granisetron & Dexamethasone & Peppermint essential oil

EXPERIMENTAL

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; Drug: Granisetron; Drug: Dexamethasone

Granisetron & Dexamethasone

ACTIVE COMPARATOR

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

Drug: Granisetron; Drug: Dexamethasone

Interventions

Peppermint essential oil BIOLOGICAL

2 drops applied on a nasal strip

Also known as: YoungLiving®, 100% pure Peppermint essential oil

Granisetron & Dexamethasone & Peppermint essential oil

Granisetron DRUG

1mg intravenous injection

Granisetron & Dexamethasone; Granisetron & Dexamethasone & Peppermint essential oil

Dexamethasone DRUG

4mg intravenous injection

Granisetron & Dexamethasone; Granisetron & Dexamethasone & Peppermint essential oil

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) I and II.
• Non-smoker.
• BMI =\< 40
• Singleton pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (10)

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

  PMID: 19803313 BACKGROUND

• 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.

  PMID: 22513952 BACKGROUND

• 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.

  PMID: 26734609 BACKGROUND

• 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.

  PMID: 24565347 BACKGROUND

• 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.

  PMID: 22344239 BACKGROUND

• 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.

  PMID: 19462494 BACKGROUND

• 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.

  PMID: 24356162 BACKGROUND

• 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.

  PMID: 26744729 BACKGROUND

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

  PMID: 10962794 BACKGROUND

• 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.

  PMID: 34002866 DERIVED

MeSH Terms

Conditions

Vomiting; Postoperative Nausea and Vomiting

Interventions

Granisetron; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Assoc Prof Dr Raha Abdul Rahman

  Consultant Anaesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 15, 2018
• Study Start: June 26, 2018
• Primary Completion: March 22, 2019
• Study Completion: April 2, 2019
• Last Updated: April 18, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)