OxygenPhase 3NCT04597723
The Effect of Oxygen Given to Patients in the Postoperative Period on Nausea and Vomiting
A Phase 3 study testing oxygen in people with Oxygen and Postoperative Nausea and Vomiting, run by Selcuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxygen, Postoperative Nausea and Vomiting
- What is being tested?
- oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2022to 3 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- The patient is using anticoagulant medication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pınar tunç tuna
Konya, 42500
Pınar t tuna, 05069549225, pinartunctuna@gmail.com
About this study
Official title: The Effect of Oxygen Given to Patients Undergoing Laparoscopic Cholecystectomy in the Postoperative Period on Nausea and Vomiting
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.
Read more
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.
Read the detailed 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.
- Conditions
- Oxygen, Postoperative Nausea and Vomiting
- Being tested
- oxygen
- Keywords
- postoperative nausea and vomiting, Oxygen
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygenDrug
Patients will be given different concentrations of oxygen.
| Study group | Role | What they receive |
|---|---|---|
| 80% oxygen | Experimental | 80% oxygen given group Receives: Drug: oxygen |
| 60% oxygen | Experimental | 60% oxygen given group Receives: Drug: oxygen |
| routine hospital care | No intervention | The patients in this group received routine hospital care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-24 hours in the postoperative period
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
Measured: 0-24 hours in the postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start3 May 2022 (estimated)
- Primary completion3 Jan 2023 (estimated)
- Study completion3 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OxygenStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Tunc Tuna Pinar, PhD, Selcuk University
- Investigators
- Hulya Bulut, Study chair, Gazi UniversitySevil Guler Demir, Study chair, Gazi UniversityFaruk Cicekci, Study chair, Selcuk UniversityHulagu Barıskaner, Study chair, Selcuk UniversityMustafa Sahin, Study chair, Selcuk UniversityInci Kara, Study chair, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597723
- Sponsor's protocol ID
- Selcuk University Konya
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxygen Given to Patients Undergoing Laparoscopic Cholecystectomy in the Postoperative Period on Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT04597723
- Acronym / sponsor ID
- Selcuk University Konya
- Conditions
- Oxygen, Postoperative Nausea and Vomiting
- Keywords
- postoperative nausea and vomiting, Oxygen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 3 May 2022 (estimated)
- Primary completion
- 3 Jan 2023 (estimated)
- Study completion
- 3 May 2023 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 80% oxygen | Experimental | Drug: oxygen80% oxygen given group |
| 60% oxygen | Experimental | Drug: oxygen60% oxygen given group |
| routine hospital care | No intervention | –The patients in this group received routine hospital care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (1 listed)
- The patient is using anticoagulant medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygenPatients will be given different concentrations of oxygen. | Drug | 60% oxygen, 80% oxygen |
Primary outcome
severity of nausea
Time frame: 0-24 hours in the postoperative period
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.
severity of vomiting
Time frame: 0-24 hours in the postoperative period
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
Related trials for Oxygen
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hulya Bulut study chair
Gazi University
Sevil Guler Demir study chair
Gazi University
Faruk Cicekci study chair
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxygen in people with Oxygen and Postoperative Nausea and Vomiting, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pınar t tuna (05069549225, pinartunctuna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of nausea (time frame: 0-24 hours in the postoperative period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.