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Cold Application Effects on Nausea and Vomiting After Laparoscopic Cholecystectomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06008262
Enrollment
54
Registered
2023-08-23
Start date
2023-07-03
Completion date
2023-12-31
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting

Keywords

Laparoscopic cholecystectomy, Postoperative Nausea and Vomiting, Cold application

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.

Interventions

OTHERCold Application

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.

Sponsors

Ankara Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change from postoperative nausea degree in a 15 minutesWithin 15 minutes of first sense of postoperative nauseaIn 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 minutesWithin 15 minutes of first sense of postoperative nauseaIn this section, postoperative vomiting will not occur. This status will evaluate with yes/no question.
Evaluation of cold application effectivenessWithin 15 minutes of first sense of postoperative nauseaIn 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026