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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04597723
Other study ID # Selcuk University Konya
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date May 3, 2022
Est. completion date May 3, 2023

Study information

Verified date October 2020
Source Selcuk University
Contact Pinar t tuna
Phone 05069549225
Email pinartunctuna@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Carbon dioxide which is insufflated to inflate the abdominal area is absorbed from the peritoneal area and it increases endogenous catecholamines, which may consequently increase nausea and vomiting. In the literature, it is indicated that oxygen application which is one of the applications aiming to prevent nausea and vomiting is a cheap method with fewer side effects in the prevention of postoperative nausea and vomiting. In the literature, studies on the prevention of nausea and vomiting by oxygen application in different surgical interventions have not arrived at a consensus regarding surgery type and oxygen amounts. There are studies evaluating 80% and 30% oxygen amounts in removing postoperative nausea and vomiting. Taking these conditions into consideration; the study has been planned for the purpose of examining the impact of giving 80% and 60% oxygen to patients to whom laparoscopic cholecystectomy is applied on postoperative nausea and vomiting in the postoperative period. The study has been planned as a randomized controlled study for the purpose of determining the impact of giving oxygen (80% to the group A, 60% to the group B and control group C) to patients who apply to the general surgery service to undergo a laparoscopic cholecystectomy on postoperative nausea and vomiting in the postoperative period. The patients in the study will have the same standard anesthesia protocol and hospital routine. The study will be terminated once a total of 111 patients have been reached. In the study randomization, the patients will be assigned to the sample group according to weeks as they may influence each other. Data will be collected using Patient Introductory Information Form, which evaluates patients' socio-demographic characteristics, as well as Perioperative Period Patient Follow-Up Form and Postoperative Period Nausea-Vomiting Frequency and Severity Evaluation Form. Statistical analysis of the data to be acquired as a result of the study will be performed in the computer environment. The results to be obtained will be evaluated at p<0,05 significance level. It is expected that the study results will provide an alternative method, which will be used in preventing the possible side effects of postoperative nausea and vomiting in patients who undergo a laparoscopic cholecystectomy. Thus, the study results may make scientific and socio-economic contributions.


Description:

Postoperative nausea and vomiting; defined as any nausea, retching or vomiting. Many studies are carried out to prevent postoperative nausea and vomiting, which may be a major concern in patients undergoing surgery. However, this remains the most undesirable complication of the surgical procedure. While the incidence of postoperative nausea and vomiting is around 30% in patients receiving general anesthesia, it can rise up to 70-80% in high risk patients. Postoperative factors affecting nausea and vomiting; are grouped as factors associated with the patient, surgery, and anesthesia. Factors related to the patient; age, gender, body mass index, pain, anxiety, presence of a history of road traffic or previous postoperative nausea and vomiting history. Surgery related factors; surgery duration and type of surgery. Factors associated with anesthesia are; type and amount of anesthetic substance, ventilation type, oral intake time, and the amount of opioid taken in the postoperative period. With postoperative nausea and vomiting; Complications such as fluid-electrolyte imbalance, wound dehiscence, hemorrhage, aspiration pneumonia, delayed discharge and increased re-hospitalization rates are seen. All these complications not only increase the length of hospital stay and cost of patients, but also negatively affect the postoperative recovery quality of the patients. In addition, postoperative nausea and vomiting is an exhausting process that requires effort for caregivers. Therefore, postoperative nausea and vomiting should be prevented. Some antiemetic drugs are used to prevent nausea and vomiting, which are undesirable complications. The use of these drugs significantly increases the patient's care costs. Unlike drugs in the prevention of postoperative nausea and vomiting in the literature; It has been observed that reducing abdominal insufflation pressure, reducing anxiety in the preoperative period, acupuncture, ginger root application, alcohol sniffing, listening to music and extra oxygen therapy practices. Oxygen administration, which is one of the applications to prevent nausea and vomiting, is stated as an inexpensive method with low side effects in preventing postoperative nausea and vomiting. One of these methods is an irreversible mask. 60% with 6lt / min oxygen application with non-recyclable mask; 80% oxygen can be given from 8 lt / min. There are studies In the literature regarding the prevention of nausea and vomiting by oxygen administration. in a study they conducted on patients who underwent colon resection; They found that administration of 80% oxygen during anesthesia and for two hours after anesthesia reduced the postoperative nausea and vomiting rate from 30% to 17%. In the study conducted on gynecological patients who underwent laparoscopy, it was found that the rates of nausea and vomiting in patients who were given 80% oxygen were statistically significantly lower than those who were given 30% oxygen. Found that the rate of nausea and vomiting decreased from 28.3% to 24.5% in the group where they gave oxygen at 8 lt / min with a simple face mask for 6 hours in the postoperative period after cesarean delivery, but it was not statistically significant. . Laparoscopic cholecystectomy is the removal of the gallbladder from three or four small holes in cases where polyps and stones are problematic in the gallbladder. One of the symptoms that patients frequently complain after laparoscopic cholecystectomy is nausea and vomiting. In laparoscopic interventions applied in abdominal surgeries, the abdominal area is inflated so that the surgery can be performed comfortably, thus increasing abdominal pressure. The diaphragm is pushed up due to the increase in abdominal pressure. This situation causes the diaphragm to be more irritated. In addition, carbon dioxide insufflated to inflate the abdominal area is absorbed from the peritoneal area and increases endogenous catecholamines. In this case, nausea and vomiting may increase. Postoperative nausea and vomiting, which prolongs the postoperative recovery period, are often seen in patients within the first 24 hours. Therefore, minimizing nausea and vomiting after laparoscopic cholecystectomy is important for the patient. In the literature, no study on oxygen administration has been found in studies conducted to relieve nausea and vomiting after laparoscopic cholecystectomy. In the studies conducted in the literature regarding the prevention of nausea and vomiting by oxygen administration in different surgical procedures, a consensus could not be reached on the type of surgery and the amount of oxygen. In addition, there are studies evaluating 80% and 30% oxygen content in relieving postoperative nausea and vomiting.Considering these situations, this research; It was planned to examine the effects of 80%, 60% and air oxygen on postoperative nausea and vomiting in patients who underwent laparoscopic cholecystectomy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 111
Est. completion date May 3, 2023
Est. primary completion date January 3, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion criteria - Surgery time is 2 hours or less - The patient does not have peripheral vascular disease - The patient does not have a psychiatric disorder - The patient can communicate verbally - The patient is not using anticoagulant drugs - The patient's hemoglobin level in the preoperative period is in the range of 12-16 g / dL - The patient's American Society of Anesthesiologist (ASA) value is between 1-2 - The patient is not smoking - The patient is between 18 and 65 years old - In the intraoperative period, the carbon dioxide gas pressure used to inflate the abdomen is between 10-12. - The patient's willingness to participate in the research - The patient does not have respiratory diseases (such as bronchitis) - The patient does not have claustrophobia Exclusion Criteria - The patient is using anticoagulant medication

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
oxygen
Patients will be given different concentrations of oxygen.

Locations

Country Name City State
Turkey Pinar tunç tuna Konya

Sponsors (2)

Lead Sponsor Collaborator
Selcuk University The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary severity of nausea severity of nausea was measured using a 10-cm visual analog scale, The patients were explained that 1 point indicated "no nausea" and 10 points indicated "severe nausea," and then they were asked to give 1-10 points for their severity of nausea. 0-24 hours in the postoperative period
Primary severity of vomiting severity of vomiting was measured using a 10-cm visual analog scale, The patients were explained that 1 point indicated "no vomiting" and 10 points indicated "severe vomiting," and then they were asked to give 1-10 points for their severity of vomiting 0-24 hours in the postoperative period
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