The Effect of Cold Vapor on Nausea and Vomiting in the Early Postoperative Period After Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

The Effect of Cold Vapor on Nausea and Vomiting in the Early Postoperative Period After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05302128
• Other study ID #: IstanbulMU12
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2022
• Source: Istanbul Medeniyet University
• Contact: Özlem Ibrahimoglu, PhD
• Phone: +905436195971
• Email: oogutlu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative nausea and vomiting (PONV) was defined by the American Society of PeriAnesthesia Nurses (ASPAN) as nausea and/or vomiting in the first 24 hours after surgery and is among the most common complications after pain in patients undergoing surgery. PONV is divided into three as early, late, and delayed. Nausea-vomiting developing within 2-6 hours after surgery is classified as early, nausea-vomiting developing within 6-24 hours after surgery is classified as delayed, and nausea and/or vomiting developing within the first 24 hours after surgery are classified as delayed PONV. PONV increases the length of stay in the recovery room, delays starting oral intake, causes fluid and electrolyte imbalance, and causes pain, dehydration, delayed wound healing, decreased patient comfort, prolonged hospitalization, and increased cost. Therefore, the prevention and management of nausea and vomiting in the perioperative period in surgical patients are very important.

Description:

Postoperative nausea and vomiting (PONV) was defined by the American Society of PeriAnesthesia Nurses (ASPAN) as nausea and/or vomiting in the first 24 hours after surgery and is among the most common complications after pain in patients undergoing surgery. PONV increases the length of stay in the recovery room, delays starting oral intake, causes fluid and electrolyte imbalance, and causes pain, dehydration, delayed wound healing, decreased patient comfort, prolonged hospitalization, and increased cost. Therefore, the prevention and management of nausea and vomiting in the perioperative period in surgical patients are very important. In a meta-analysis study that included data from eleven countries, the prevalence of PONV was 27.7%, the prevalence of postoperative nausea was 31.4% and the prevalence of post-operative vomiting was 16.8%. In a study conducted in Turkey, it was reported that 45.9% of surgical patients had nausea and 23.6% had vomiting in the postoperative period. In another study conducted in the postoperative recovery unit, it was reported that 29% of the patients experienced nausea and vomiting. The risk of PONV may vary depending on the patient, anesthesia, and surgical intervention. Patient-related risk factors include female gender, young age (under 50 years of age), obesity, history of motion sickness; anesthesia-related risk factors include the type of anesthesia, duration of administration, use of volatile anesthetics, opioids, and nitrous oxide; Among the risk factors for previous surgical interventions are laparoscopic, bariatric, gynecological and cholecystectomy surgeries. Pharmacological treatment, non-pharmacological treatment methods, or both are used in the management of PONV in patients undergoing surgical intervention. Today, a multimodal approach is recommended in the management of PONV in early recovery protocols in surgical patients. Antiemetic drugs used among pharmacological methods can cause side effects such as headache, constipation, drowsiness, tremor, irregular heartbeat, and wound infection. Therefore, non-pharmacological treatment methods have an important place in care practices. In the literature, there are many studies on the successful application of non-pharmacological treatment methods such as massage, progressive relaxation exercises, hypnosis, acupuncture, yoga, acupressure, transcutaneous electrical nerve stimulation, music therapy, herbal treatments, and aromatherapy in the prevention of PONV. The cold application creates vasoconstriction in the vessels in the area where it is applied, decreases the metabolic rate, and reduces edema. The cold application reduces muscle temperature by reducing the tension sensitivity of muscle spindles with the reflex effect of heat receptors or inactivating trigger points in the muscles and helps to reduce muscle spasm. Thus, it reduces skin sensitivity by lowering the temperature of nerve fibers and receptors. Cold application is especially beneficial in post-traumatic pain, swelling, and muscle spasm. Temperature can affect the release of odorous volatile substances in drugs. The cold application also has clinically important potential effects on nausea caused by unpleasant tastes by reducing the olfactory component of negative aromas. Cold can be applied in different ways. One of them is administration by inhalation. In the literature, there are studies on the positive effects of cold vapor application on sore throat, cough, swallowing, and hoarseness. In a study, it was determined that postoperative nausea and vomiting were less in patients who received oral care with the cold application after laparoscopic myomectomy compared to the control group. There is no study in the literature examining the effect of cold vapor application on PONV.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being 18 years or older
• To undergo laparoscopic cholecystectomy
• Having an ASA score of 1-2
• Getting 2 points from the Ramsay Sedation Scale in the postoperative recovery room.
• Having a Modified Aldrete score of at least 9 in the postoperative recovery room
• To be willing to participate in the study.

Exclusion Criteria:

• To undergo emergency surgery
• Being under the age of 18
• Having an ASA score of 3 and above
• Not agreeing to participate in the study.

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy
• Nausea
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Vomiting
• Vomiting

Intervention

Other:
• Cold vapor
Before surgery, the socio-demographic data of the patients will be recorded. After surgery, patients will be evaluated in the recovery room for their suitability to participate in the study with the Ramsay sedation scale and the Modified Aldrete Scale. Cold vapor will be applied to the patients for 15 minutes in the recovery room during the postoperative period. The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5, air blowing intensity 5, heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of nausea and vomiting before and 15 minutes after the cold vapor application in the recovery room and at the 2nd, 6th,12th, and 24th hours after the cold vapor application in the postoperative service.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Medeniyet University	Atlas University

References & Publications (27)

American Society of PeriAnesthesia Nurses PONV/PDNV Strategic Work Team. ASPAN'S evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. J Perianesth Nurs. 2006 Aug;21(4):230-50. — View Citation

Amirhosseini M, Dehghan M, Mangolian Shahrbabaki P, Pakmanesh H. Effectiveness of Aromatherapy for Relief of Pain, Nausea, and Vomiting after Percutaneous Nephrolithotomy: A Randomized Controlled Trial. Complement Med Res. 2020;27(6):440-448. doi: 10.1159/000508333. Epub 2020 Jun 23. — View Citation

Apfel CC, Läärä E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. — View Citation

Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. — View Citation

Brems C, Barnett J, Parret VC, Metzger J, Johnson ME. Alternative and complementary treatment needs and experiences of women with breast cancer. J Altern Complement Med. 2013 Jul;19(7):657-63. doi: 10.1089/acm.2012.0161. Epub 2013 Feb 1. — View Citation

Bulut H, Erden S, Demir SG, Çakar B, Erdogan Z, Demir N, Ay A, Aydin E. The Effect of Cold Vapor Applied for Sore Throat in the Early Postoperative Period. J Perianesth Nurs. 2016 Aug;31(4):291-7. doi: 10.1016/j.jopan.2014.10.005. Epub 2016 Feb 24. — View Citation

Campos de Carvalho E, Martins FT, dos Santos CB. A pilot study of a relaxation technique for management of nausea and vomiting in patients receiving cancer chemotherapy. Cancer Nurs. 2007 Mar-Apr;30(2):163-7. — View Citation

Cronin SN, Odom-Forren J, Roberts H, Thomas M, Williams S, Wright MI. Effects of Controlled Breathing, With or Without Aromatherapy, in the Treatment of Postoperative Nausea. J Perianesth Nurs. 2015 Oct;30(5):389-97. doi: 10.1016/j.jopan.2015.03.010. — View Citation

Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833. Review. Erratum in: Anesth Analg. 2020 Nov;131(5):e241. — View Citation

Gecit S, Ozbayir T. Evaluation of Preoperative Risk Assessment and Postoperative Nausea and Vomiting: Importance for Nurses. J Perianesth Nurs. 2020 Dec;35(6):625-629. doi: 10.1016/j.jopan.2020.04.006. Epub 2020 Aug 7. — View Citation

Gonella S, Dimonte V. Potential effects of pleasant and cold stimuli on nausea and vomiting induced by disgusting tastes. J Neurosci Res. 2016 May;94(5):366-77. doi: 10.1002/jnr.23724. Epub 2016 Feb 19. Review. — View Citation

Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(®)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y. Review. — View Citation

Horn CC, Wallisch WJ, Homanics GE, Williams JP. Pathophysiological and neurochemical mechanisms of postoperative nausea and vomiting. Eur J Pharmacol. 2014 Jan 5;722:55-66. doi: 10.1016/j.ejphar.2013.10.037. Epub 2013 Oct 26. Review. — View Citation

Hunt K, Ernst E. The evidence-base for complementary medicine in children: a critical overview of systematic reviews. Arch Dis Child. 2011 Aug;96(8):769-76. doi: 10.1136/adc.2009.179036. Epub 2010 Jul 6. Review. — View Citation

Karagozoglu S, Tekyasar F, Yilmaz FA. Effects of music therapy and guided visual imagery on chemotherapy-induced anxiety and nausea-vomiting. J Clin Nurs. 2013 Jan;22(1-2):39-50. doi: 10.1111/jocn.12030. Epub 2012 Nov 8. — View Citation

Karaman S, Karaman T, Tapar H, Dogru S, Suren M. A randomized placebo-controlled study of aromatherapy for the treatment of postoperative nausea and vomiting. Complement Ther Med. 2019 Feb;42:417-421. doi: 10.1016/j.ctim.2018.12.019. Epub 2018 Dec 28. — View Citation

Kori K, Oikawa T, Odaguchi H, Omoto H, Hanawa T, Minami T. Go-rei-San, a Kampo medicine, reduces postoperative nausea and vomiting: a prospective, single-blind, randomized trial. J Altern Complement Med. 2013 Dec;19(12):946-50. doi: 10.1089/acm.2013.0118. Epub 2013 Jul 9. — View Citation

Lin KY, Hu YT, Chang KJ, Lin HF, Tsauo JY. Effects of yoga on psychological health, quality of life, and physical health of patients with cancer: a meta-analysis. Evid Based Complement Alternat Med. 2011;2011:659876. doi: 10.1155/2011/659876. Epub 2011 Mar 9. — View Citation

Maghami M, Afazel MR, Azizi-Fini I, Maghami M. The effect of aromatherapy with peppermint essential oil on nausea and vomiting after cardiac surgery: A randomized clinical trial. Complement Ther Clin Pract. 2020 Aug;40:101199. doi: 10.1016/j.ctcp.2020.101199. Epub 2020 May 18. — View Citation

Montazeri AS, Raei M, Ghanbari A, Dadgari A, Montazeri AS, Hamidzadeh A. Effect of herbal therapy to intensity chemotherapy-induced nausea and vomiting in cancer patients. Iran Red Crescent Med J. 2013 Feb;15(2):101-6. doi: 10.5812/ircmj.4392. Epub 2013 Feb 5. — View Citation

Montgomery GH, Schnur JB, Kravits K. Hypnosis for cancer care: over 200 years young. CA Cancer J Clin. 2013 Jan;63(1):31-44. doi: 10.3322/caac.21165. Epub 2012 Nov 20. Review. — View Citation

Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29. — View Citation

Öbrink E, Jildenstål P, Oddby E, Jakobsson JG. Post-operative nausea and vomiting: update on predicting the probability and ways to minimize its occurrence, with focus on ambulatory surgery. Int J Surg. 2015 Mar;15:100-6. doi: 10.1016/j.ijsu.2015.01.024. Epub 2015 Jan 29. Review. — View Citation

Saberi F, Sadat Z, Abedzadeh-Kalahroudi M, Taebi M. Acupressure and ginger to relieve nausea and vomiting in pregnancy: a randomized study. Iran Red Crescent Med J. 2013 Sep;15(9):854-61. doi: 10.5812/ircmj.12984. Epub 2013 Sep 5. — View Citation

Sahbaz M, Khorshid L. The Effect of Cold Vapor and Ice Cube Absorption in the Early Postoperative Period on Sore Throat and Hoarseness Induced by Intubation. J Perianesth Nurs. 2020 Oct;35(5):518-524. doi: 10.1016/j.jopan.2019.12.007. Epub 2020 May 10. — View Citation

Stallings-Welden LM, Doerner M, Ketchem EL, Benkert L, Alka S, Stallings JD. A Comparison of Aromatherapy to Standard Care for Relief of PONV and PDNV in Ambulatory Surgical Patients. J Perianesth Nurs. 2018 Apr;33(2):116-128. doi: 10.1016/j.jopan.2016.09.001. Epub 2017 Mar 16. — View Citation

Weibel S, Rücker G, Eberhart LH, Pace NL, Hartl HM, Jordan OL, Mayer D, Riemer M, Schaefer MS, Raj D, Backhaus I, Helf A, Schlesinger T, Kienbaum P, Kranke P. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis. Cochrane Database Syst Rev. 2020 Oct 19;10:CD012859. doi: 10.1002/14651858.CD012859.pub2. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cold vapor	The Visual Analogue Scale (VAS) of the patients for nausea who underwent cold vapor is decreased compared to those who do not. A score between 0 and 10 is taken from the VAS. It is good that the score from the VAS has decreased.	First 24 hours after surgery
Primary	Cold vapor	The Postoperative Nausea and Vomiting Impact Scale of the patients for nausea and vomiting who underwent cold vapor are decreased compared to those who do not. A score between 0 and 6 is taken from the Postoperative Nausea and Vomiting Impact Scale. It is good that the score from the Postoperative Nausea and Vomiting Impact Scale has decreased.	First 24 hours after surgery

External Links

•   Aygin, D. (2016). Bulanti ve kusma. Yogun Bakim Hemsireligi Dergisi, 20(1), 44-56.
•   Durmaz, M., & Burucu, R. (2019). Ameliyat Sonrasi Bulanti ve Kusmayi Önlemede Kullanilan Farmakolojik Olmayan Yöntemlerin Kanit Düzeyleri. Izmir Katip Çelebi Üniversitesi Saglik Bilimleri Fakültesi Dergisi, 4(3), 97-104.
•   Irmak, B., & Karadag, M. Ameliyat sonrasi bulanti ve kusmanin yönetiminde aromaterapinin etkisini degerlendiren çalismalarin incelenmesi. Cerrahi Ameliyathane Sterilizasyon Enfeksiyon Kontrol Hemsireligi Dergisi, 2(1), 11-30.
•   Jung, M. Y., Choi, H. S., & Park, K. Y. (2012). Effects of Postoperative Oral Care Using Cold Therapy on Nausea, Vomiting and Oral Discomfort in Patients with Laparoscopic Myomectomy. Journal of Korean Academy of Fundamentals of Nursing, 19(3), 292-301.
•   Sözen, K. K. (2020). Ameliyat sonrasi derlenme ünitesinde görülen erken dönem komplikasyonlarinin degerlendirilmesi. Çukurova Anestezi ve Cerrahi Bilimler Dergisi, 3(3), 212-222.
•   Yaman Aktas, Y., Gürçayir, D., & Atalay, C. (2018). Ameliyat sonrasi bulanti kusma yönetiminde kanita dayali uygulamalar. Dicle Tip Dergisi, 45(3), 341-351.
•   Zaman, F., & Karahan, E. (2020). The Effect of Cold Vapor Treated to Thyroidectomy Patients During Early Postoperative Period. Eastern Journal of Medicine, 25(1), 118-125.