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Cold Application Effects on Nausea and Vomiting After Laparoscopic Cholecystectomy

Primary Purpose

Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cold Application
Sponsored by
Ankara Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laparoscopic Cholecystectomy focused on measuring Laparoscopic cholecystectomy, Postoperative Nausea and Vomiting, Cold application

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inclusion in ASA (American Society of Anesthesiologists) I-II-III class Being over 18 years old Having received general anesthesia Preoperative pain value of 6 or less Exclusion Criteria: 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

Sites / Locations

  • Neslihan Ilkaz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cold Application Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Change from postoperative vomiting in a 15 minutes
In this section, postoperative vomiting will not occur. This status will evaluate with yes/no question.
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.

Secondary Outcome Measures

Full Information

First Posted
August 15, 2023
Last Updated
August 22, 2023
Sponsor
Ankara Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT06008262
Brief Title
Cold Application Effects on Nausea and Vomiting After Laparoscopic Cholecystectomy
Official Title
The Effect of Cold Application on Nausea and Vomiting After Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Medipol University

4. Oversight

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

5. Study Description

Brief Summary
This clinical trial aims to test the effect of cold application on postoperative nausea and vomiting.
Detailed Description
Nausea and vomiting seen within the first 24 hours after surgery are defined as "Post-Operative Nausea and Vomiting (POBK). Postoperative nausea and vomiting are one of the most common complications of anesthesia. It has been reported that the risk of nausea and vomiting is particularly high after laparoscopic cholecystectomy. It is stated that vagal stimulation and pneumoperitoneum process may trigger this situation in laparoscopic surgeries. Nausea and vomiting after surgery is a very uncomfortable situation for the patient. There are several pharmacological methods to prevent and treat POBK. However, it is stated that the non-pharmacological approach should also be brought to the fore. It is stated that cold reduces molecular activity and causes vasoconstriction. It is stated that cold can slow down the blood flow to the vomiting center in the medulla oblongata and the progression of nausea and vomiting can be slowed down. In this way, it is thought that it will contribute to increasing patient satisfaction and providing cost-effective care. The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the patients before and after the surgery, the study will conduct with various data collection forms. These forms are; the patient data collection form, numerical evaluation scale, preoperative Apfel risk score evaluation form, postoperative nausea severity evaluation form, and perceived effectiveness of the ice pack forms will use. Laparoscopic cholecystectomy will perform and all cases meeting the inclusion criteria will evaluate. Patients will randomize. The ice pack will apply in group-I (n=27), and group II (n=27) will be the control group. An ice pack will be applied to the posterior upper neck regions of patients with nausea in Group-I, at 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. 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. Standard procedures will be applied to these patients within the scope of nursing practices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting
Keywords
Laparoscopic cholecystectomy, Postoperative Nausea and Vomiting, Cold application

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cold Application Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cold Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from postoperative nausea degree in a 15 minutes
Description
In this section, the degree of postoperative nausea will decrease or disappear. This status will evaluate with Numerical Evaluation Scale.
Time Frame
Within 15 minutes of first sense of postoperative nausea
Title
Change from postoperative vomiting in a 15 minutes
Description
In this section, postoperative vomiting will not occur. This status will evaluate with yes/no question.
Time Frame
Within 15 minutes of first sense of postoperative nausea
Title
Evaluation of cold application effectiveness
Description
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.
Time Frame
Within 15 minutes of first sense of postoperative nausea

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion in ASA (American Society of Anesthesiologists) I-II-III class Being over 18 years old Having received general anesthesia Preoperative pain value of 6 or less Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neslihan Ilkaz, PhD
Organizational Affiliation
Ankara Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neslihan Ilkaz
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
28389799
Citation
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.
Results Reference
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PubMed Identifier
32467512
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. Erratum In: Anesth Analg. 2020 Nov;131(5):e241.
Results Reference
background
PubMed Identifier
26408511
Citation
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.
Results Reference
background
PubMed Identifier
35637077
Citation
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.
Results Reference
background
PubMed Identifier
32718430
Citation
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.
Results Reference
background
PubMed Identifier
16935735
Citation
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.
Results Reference
background
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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Cold Application Effects on Nausea and Vomiting After Laparoscopic Cholecystectomy

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