Skip to main content
Clinical Trials/NCT06008262
NCT06008262Enrolling By InvitationNot Applicable

The Effect of Cold Application on Nausea and Vomiting After Laparoscopic Cholecystectomy

Ankara Medipol University1 site in 1 country54 target enrollmentStarted: July 3, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
54
Locations
1
Primary Endpoint
Change from postoperative vomiting in a 15 minutes

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change from postoperative vomiting in a 15 minutes

Time Frame: Within 15 minutes of first sense of postoperative nausea

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

Change from postoperative nausea degree in a 15 minutes

Time Frame: Within 15 minutes of first sense of postoperative nausea

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

Evaluation of cold application effectiveness

Time Frame: Within 15 minutes of first sense of postoperative nausea

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ankara Medipol University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Neslihan Ilkaz

Assistant Professor

Ankara Medipol University

Study Sites (1)

Loading locations...

Similar Trials