Cold Application Effects on Nausea and Vomiting After Laparoscopic Cholecystectomy

NCT06008262 | Unknown

• 1 other identifier: E-81477236-604.01.01-1666
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to test the effect of cold application on postoperative nausea and vomiting.

Conditions

Laparoscopic Cholecystectomy; Postoperative Nausea and Vomiting

Keywords

Laparoscopic cholecystectomy; Postoperative Nausea and Vomiting; Cold application

Outcome Measures

Primary Outcomes (3)

• Change from postoperative nausea degree in a 15 minutes

  In this section, the degree of postoperative nausea will decrease or disappear. This status will evaluate with Numerical Evaluation Scale.

  Within 15 minutes of first sense of postoperative nausea

• Change from postoperative vomiting in a 15 minutes

  In this section, postoperative vomiting will not occur. This status will evaluate with yes/no question.

  Within 15 minutes of first sense of postoperative nausea

• Evaluation of cold application effectiveness

  In this section, the effectiveness of cold application with a Ice Pack Perceived Effectiveness Form. In this form, there are three different expressions as the application reduced nausea, did not affect nausea, increased nausea.

  Within 15 minutes of first sense of postoperative nausea

Study Arms (2)

Cold Application Group

EXPERIMENTAL

An ice pack will be applied to the posterior upper neck regions of patients with nausea in Group-I, with an interval of 5 minutes. The vital signs of the patients will be recorded. The severity of nausea and pain of the patients will be evaluated with a numerical rating scale. The effectiveness of its application as perceived by the patient will be evaluated.

Other: Cold Application

Control Group

NO INTERVENTION

In the control group, the severity of nausea and pain will be determined by using a numerical evaluation scale in patients with postoperative nausea. Vital signs will be recorded at this stage. Normal procedures will be applied to these patients within the scope of nursing practices.

Interventions

Cold Application OTHER

An ice pack will be applied to the posterior upper neck regions of patients with nausea in Group-I, with an interval of 5 minutes. The vital signs of the patients will be recorded. The severity of nausea and pain of the patients will be evaluated with a numerical rating scale. The effectiveness of its application as perceived by the patient will be evaluated.

Cold Application Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years old
• Having received general anesthesia
• Preoperative pain value of 6 or less

You may not qualify if:

• Severe nausea in the preoperative period
• Being hypothermic in the postoperative period
• Having had head and neck surgery
• Taking prophylactic antiemetics
• Postoperative pain value of 7 and above

Sponsors & Collaborators

• Ankara Medipol University: lead

Study Sites (1)

Neslihan Ilkaz

Ankara, Turkey (Türkiye)

Location

Related Publications (7)

• Son JS, Oh JY, Ko S. Effects of hypercapnia on postoperative nausea and vomiting after laparoscopic surgery: a double-blind randomized controlled study. Surg Endosc. 2017 Nov;31(11):4576-4582. doi: 10.1007/s00464-017-5519-8. Epub 2017 Apr 7.

  PMID: 28389799 BACKGROUND

• 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.

  PMID: 32467512 BACKGROUND

• Hooper VD. SAMBA Consensus Guidelines for the Management of Postoperative Nausea and Vomiting: An Executive Summary for Perianesthesia Nurses. J Perianesth Nurs. 2015 Oct;30(5):377-82. doi: 10.1016/j.jopan.2015.08.009. No abstract available.

  PMID: 26408511 BACKGROUND

• Scharfenberg DR, Salcido A, Malone P, Clark J, Steele MA. Managing Postoperative Nausea With an Application of Ice Pack to the Posterior Upper Neck. J Perianesth Nurs. 2022 Dec;37(6):774-777. doi: 10.1016/j.jopan.2021.12.010. Epub 2022 May 28.

  PMID: 35637077 BACKGROUND

• Hymel N, Davies M. Evidence-Based Antiemetic Decision Tool for Management of Postoperative Nausea and Vomiting in Patients at High Risk of QT Prolongation and Patients Receiving Neurotransmitter-Modulating Medications. AANA J. 2020 Aug;88(4):312-318.

  PMID: 32718430 BACKGROUND

• 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. doi: 10.1016/j.jopan.2006.06.003. No abstract available.

  PMID: 16935735 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

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Study Officials

• Neslihan Ilkaz, PhD

  Ankara Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 23, 2023
• Study Start: July 3, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

TU (1)