Nausea, PostoperativeNCT06022705
Evaluation of the Effect of APFEL Risk Score and Fasting Periods on Postoperative Nausea and/or Vomiting
An observational study of Nausea, Postoperative and Vomiting, Postoperative, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study, it is aimed to determine the effect of Apfel risk score and fasting times on postoperative nausea and vomiting (PONV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea, Postoperative, Vomiting, Postoperative, APFEL RİSK SCORE
- How many people
- 321 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2023to 20 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of the study will be composed of patients who applied for elective surgery to Çukurova University Medical Faculty Balcalı Training and Research Hospital General Surgery Clinic and Tarsus State Hospital General Surgery Clinic between the dates of the study. The sample, on the other hand, will consist of a total of 250 patients who comply with the selection criteria, agree to participate in the study, and are determined by power analysis. The sample of the study was carried out using an unknown population model. The data obtained from the study of Weibel et al. (2020) were used for the effect size to be used in the calculation of the sample number (Weibel et al., 2020).
Who may be able to join
- Being over 18 years old
- To have applied for elective surgery,
- Being hospitalized 6 hours before the operation,
- American Society of Anesthesiologists (ASA) score I-III
- Not having a vision-hearing problem
- Not having chronic pain,
- No alcohol and/or substance addiction,
Who cannot join
- Performing emergency surgical intervention,
- Need for intensive care after surgery
Trial locations and contacts
1 site in 1 country.
About this study
This study, it is aimed to determine the effect of Apfel risk score and fasting times on postoperative nausea and vomiting (PONV).
Read the detailed description
PONV are common causes of delayed discharge. PONV; nausea and/or vomiting in the first 24 hours after surgery. The incidence of PONV after elective surgeries varies between 30-80% depending on anesthesia, type of surgery, and risk factors of the patient. PONV is not only an uncomfortable complication for the patient but is associated with significant patient dissatisfaction. It also includes dehydration, electrolyte imbalance, acid-base imbalance, pulmonary aspiration, pneumothorax, hypoxia, esophageal rupture, increased intracranial pressure, wound problems, bleeding, delayed oral intake, prolonged hospitalization, fatigue, anxiety, unexpected hospital readmission, increased medical costs. Therefore, the prevention and management of nausea and/or vomiting in the perioperative period in surgical patients is very important.
In the preoperative period, patients' risk of nausea and/or vomiting should be evaluated with standard measurement tools. The most commonly used is the Apfel risk score, including four risk factors. These; female gender, history of PONV and/or motion sickness, non-smoking, and postoperative opioid use. In the presence of 0, 1, 2, 3, and 4 risk factors, the incidence of PONV is approximately 10%, 20%, 40%, 60%, and 80%, respectively. It has been observed that the use of risk scoring for PONV significantly reduces the rate of nausea and vomiting in the postoperative period. The risk of PONV varies depending on the patient, the type of anesthesia and the surgery. Female gender, young age, non-smoking, history of PONV or motion sickness are important risk factors for PONV. Type of anesthesia, duration of administration, use of volatile anesthetics and nitrous oxide, and use of opioids in the perioperative period are among other risk factors. It has been reported that PONV is seen more frequently after laparoscopic, bariatric, gynecological surgery, and cholecystectomy.
In order to prevent the development of nausea-vomiting and aspiration pneumonia during and after the operation, patients should be fasted for a certain period of time before the operation. Fasting periods in the preoperative period should not be long enough to cause adverse outcomes in patients. It has been reported in the literature that long preoperative fasting periods do not prevent some complications, but on the contrary increase them. Therefore, it is emphasized that it is unnecessary to starve patients for a long time in the preoperative period. In the study of Hausel et al., it was reported that patients who were fasted for 12-24 hours before surgery had more nausea and vomiting in the postoperative period than patients who were fasted for a short time and were given oral carbohydrate-containing fluids. According to the results of different studies conducted in this area, it has been reported that reducing the preoperative fasting period eliminates the patient's feeling of thirst before the operation, reduces nausea and vomiting, alleviates anxiety, increases patient comfort, accelerates recovery, and significantly shortens the length of hospital stay. It is stated that a short pre-operative fasting period reduces the loss of nitrogen in the urine and prevents loss of muscle strength, reduces the feeling of anxiety and thirst before the operation, and increases patient comfort by reducing nausea and vomiting in the early postoperative period. It has been reported that there are limited clinical studies to explain the relationship between perioperative fasting time and PONV in terms of the level of evidence. In this respect, it is important to determine the relationship between risk factors preoperative fasting times, and PONV.
- Keywords
- APFEL Risk Score,, Postoperative Nausea and Vomiting, Preoperative Fasting
- Medical subject headings
- Postoperative Nausea and Vomiting
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the risk of posoperative nausea and vomiting.
APFEL risk score. It is a valid tool to assess PONV and/or motion sickness, non-smoking status, and postoperative opioid use. Accordingly, 0-1 indicates low, 2-3 moderate and ≥3 high risk for ASBK. Accordingly, 0-1 indicates low risk, 2-3 moderate and ≥3 high risk for ASBK. In the presence of 0, 1, 2, 3 and 4 risk factors, the incidence of ASBK was reported as 10%, 20%, 40%, 60% and 80%, respectively.
Measured: 24 hours
Determination of postoperative nausea and vomiting.
Nausea and Vomiting Evaluation Form. In our study, ASBK status will be evaluated as "Yes/No" at 0, 2, 4, 8, 12 and 24 hours using the Nausea and Vomiting Evaluation Form.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start28 Aug 2023
- Primary completion5 Apr 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Nausea, PostoperativeStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 321 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Collaborators
- Tarsus University
- Responsible party
- Principal investigator, Derya Gezer, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022705
- Sponsor's protocol ID
- TarsusU
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results regarding the relationship between APFEL risk score fasting times and PONV will be shared. However, personal information will not be shared.
Publications
Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.
PubMed 23035051Gan 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.
PubMed 32467512Wan KM, Carter J, Philp S. Predictors of early discharge after open gynecological surgery in the setting of an enhanced recovery after surgery protocol. J Obstet Gynaecol Res. 2016 Oct;42(10):1369-1374. doi: 10.1111/jog.13045. Epub 2016 Jun 29.
PubMed 27353883Parrish RH 2nd, Findley R, Elias KM, Kramer B, Johnson EG, Gramlich L, Nelson GS. Pharmacotherapeutic prophylaxis and post-operative outcomes within an Enhanced Recovery After Surgery (ERAS(R)) program: A randomized retrospective cohort study. Ann Med Surg (Lond). 2021 Dec 14;73:103178. doi: 10.1016/j.amsu.2021.103178. eCollection 2022 Jan.
PubMed 35003725Elvir-Lazo OL, White PF, Yumul R, Cruz Eng H. Management strategies for the treatment and prevention of postoperative/postdischarge nausea and vomiting: an updated review. F1000Res. 2020 Aug 13;9:F1000 Faculty Rev-983. doi: 10.12688/f1000research.21832.1. eCollection 2020.
PubMed 32913634Obrink E, Jildenstal P, Oddby E, Jakobsson JG. Post-operative nausea and vomiting: update on predicting the probability and ways to minimize its occurrence, with focus on ambulatory surgery. Int J Surg. 2015 Mar;15:100-6. doi: 10.1016/j.ijsu.2015.01.024. Epub 2015 Jan 29.
PubMed 25638733Veiga-Gil L, Pueyo J, Lopez-Olaondo L. Postoperative nausea and vomiting: physiopathology, risk factors, prophylaxis and treatment. Rev Esp Anestesiol Reanim. 2017 Apr;64(4):223-232. doi: 10.1016/j.redar.2016.10.001. Epub 2016 Dec 29. English, Spanish.
PubMed 28041609Cao X, White PF, Ma H. An update on the management of postoperative nausea and vomiting. J Anesth. 2017 Aug;31(4):617-626. doi: 10.1007/s00540-017-2363-x. Epub 2017 Apr 28.
PubMed 28455599Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
PubMed 30426190Gecit S, Ozbayir T. Evaluation of Preoperative Risk Assessment and Postoperative Nausea and Vomiting: Importance for Nurses. J Perianesth Nurs. 2020 Dec;35(6):625-629. doi: 10.1016/j.jopan.2020.04.006. Epub 2020 Aug 7.
PubMed 32778493Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
PubMed 10485781American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.
PubMed 21307770Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
PubMed 28045707Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
PubMed 28385477Weibel S, Rucker G, Eberhart LH, Pace NL, Hartl HM, Jordan OL, Mayer D, Riemer M, Schaefer MS, Raj D, Backhaus I, Helf A, Schlesinger T, Kienbaum P, Kranke P. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis. Cochrane Database Syst Rev. 2020 Oct 19;10(10):CD012859. doi: 10.1002/14651858.CD012859.pub2.
PubMed 33075160
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of APFEL Risk Score and Fasting Periods on Postoperative Nausea and/or Vomiting
- ClinicalTrials.gov ID
- NCT06022705
- Acronym / sponsor ID
- TarsusU
- Keywords
- APFEL Risk Score,, Postoperative Nausea and Vomiting, Preoperative Fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Collaborators
- Tarsus University
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 5 Sep 2023 (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.
This study, it is aimed to determine the effect of Apfel risk score and fasting times on postoperative nausea and vomiting (PONV).
Detailed description
PONV are common causes of delayed discharge. PONV; nausea and/or vomiting in the first 24 hours after surgery. The incidence of PONV after elective surgeries varies between 30-80% depending on anesthesia, type of surgery, and risk factors of the patient. PONV is not only an uncomfortable complication for the patient but is associated with significant patient dissatisfaction. It also includes dehydration, electrolyte imbalance, acid-base imbalance, pulmonary aspiration, pneumothorax, hypoxia, esophageal rupture, increased intracranial pressure, wound problems, bleeding, delayed oral intake, prolonged hospitalization, fatigue, anxiety, unexpected hospital readmission, increased medical costs. Therefore, the prevention and management of nausea and/or vomiting in the perioperative period in surgical patients is very important.
In the preoperative period, patients' risk of nausea and/or vomiting should be evaluated with standard measurement tools. The most commonly used is the Apfel risk score, including four risk factors. These; female gender, history of PONV and/or motion sickness, non-smoking, and postoperative opioid use. In the presence of 0, 1, 2, 3, and 4 risk factors, the incidence of PONV is approximately 10%, 20%, 40%, 60%, and 80%, respectively. It has been observed that the use of risk scoring for PONV significantly reduces the rate of nausea and vomiting in the postoperative period. The risk of PONV varies depending on the patient, the type of anesthesia and the surgery. Female gender, young age, non-smoking, history of PONV or motion sickness are important risk factors for PONV. Type of anesthesia, duration of administration, use of volatile anesthetics and nitrous oxide, and use of opioids in the perioperative period are among other risk factors. It has been reported that PONV is seen more frequently after laparoscopic, bariatric, gynecological surgery, and cholecystectomy.
In order to prevent the development of nausea-vomiting and aspiration pneumonia during and after the operation, patients should be fasted for a certain period of time before the operation. Fasting periods in the preoperative period should not be long enough to cause adverse outcomes in patients. It has been reported in the literature that long preoperative fasting periods do not prevent some complications, but on the contrary increase them. Therefore, it is emphasized that it is unnecessary to starve patients for a long time in the preoperative period. In the study of Hausel et al., it was reported that patients who were fasted for 12-24 hours before surgery had more nausea and vomiting in the postoperative period than patients who were fasted for a short time and were given oral carbohydrate-containing fluids. According to the results of different studies conducted in this area, it has been reported that reducing the preoperative fasting period eliminates the patient's feeling of thirst before the operation, reduces nausea and vomiting, alleviates anxiety, increases patient comfort, accelerates recovery, and significantly shortens the length of hospital stay. It is stated that a short pre-operative fasting period reduces the loss of nitrogen in the urine and prevents loss of muscle strength, reduces the feeling of anxiety and thirst before the operation, and increases patient comfort by reducing nausea and vomiting in the early postoperative period. It has been reported that there are limited clinical studies to explain the relationship between perioperative fasting time and PONV in terms of the level of evidence. In this respect, it is important to determine the relationship between risk factors preoperative fasting times, and PONV.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study will be composed of patients who applied for elective surgery to Çukurova University Medical Faculty Balcalı Training and Research Hospital General Surgery Clinic and Tarsus State Hospital General Surgery Clinic between the dates of the study. The sample, on the other hand, will consist of a total of 250 patients who comply with the selection criteria, agree to participate in the study, and are determined by power analysis. The sample of the study was carried out using an unknown population model. The data obtained from the study of Weibel et al. (2020) were used for the effect size to be used in the calculation of the sample number (Weibel et al., 2020).
Key inclusion criteria (7 listed)
- Being over 18 years old
- To have applied for elective surgery,
- Being hospitalized 6 hours before the operation,
- American Society of Anesthesiologists (ASA) score I-III
- Not having a vision-hearing problem
Key exclusion criteria (2 listed)
- Performing emergency surgical intervention,
- Need for intensive care after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determining the risk of posoperative nausea and vomiting.
Time frame: 24 hours
APFEL risk score. It is a valid tool to assess PONV and/or motion sickness, non-smoking status, and postoperative opioid use. Accordingly, 0-1 indicates low, 2-3 moderate and ≥3 high risk for ASBK. Accordingly, 0-1 indicates low risk, 2-3 moderate and ≥3 high risk for ASBK. In the presence of 0, 1, 2, 3 and 4 risk factors, the incidence of ASBK was reported as 10%, 20%, 40%, 60% and 80%, respectively.
Determination of postoperative nausea and vomiting.
Time frame: 24 hours
Nausea and Vomiting Evaluation Form. In our study, ASBK status will be evaluated as "Yes/No" at 0, 2, 4, 8, 12 and 24 hours using the Nausea and Vomiting Evaluation Form.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 23035051Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.
- Background: PubMed 32467512Gan 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.
- Background: PubMed 27353883Wan KM, Carter J, Philp S. Predictors of early discharge after open gynecological surgery in the setting of an enhanced recovery after surgery protocol. J Obstet Gynaecol Res. 2016 Oct;42(10):1369-1374. doi: 10.1111/jog.13045. Epub 2016 Jun 29.
- Background: PubMed 35003725Parrish RH 2nd, Findley R, Elias KM, Kramer B, Johnson EG, Gramlich L, Nelson GS. Pharmacotherapeutic prophylaxis and post-operative outcomes within an Enhanced Recovery After Surgery (ERAS(R)) program: A randomized retrospective cohort study. Ann Med Surg (Lond). 2021 Dec 14;73:103178. doi: 10.1016/j.amsu.2021.103178. eCollection 2022 Jan.
- Background: PubMed 32913634Elvir-Lazo OL, White PF, Yumul R, Cruz Eng H. Management strategies for the treatment and prevention of postoperative/postdischarge nausea and vomiting: an updated review. F1000Res. 2020 Aug 13;9:F1000 Faculty Rev-983. doi: 10.12688/f1000research.21832.1. eCollection 2020.
- Background: PubMed 25638733Obrink E, Jildenstal P, Oddby E, Jakobsson JG. Post-operative nausea and vomiting: update on predicting the probability and ways to minimize its occurrence, with focus on ambulatory surgery. Int J Surg. 2015 Mar;15:100-6. doi: 10.1016/j.ijsu.2015.01.024. Epub 2015 Jan 29.
- Background: PubMed 28041609Veiga-Gil L, Pueyo J, Lopez-Olaondo L. Postoperative nausea and vomiting: physiopathology, risk factors, prophylaxis and treatment. Rev Esp Anestesiol Reanim. 2017 Apr;64(4):223-232. doi: 10.1016/j.redar.2016.10.001. Epub 2016 Dec 29. English, Spanish.
- Background: PubMed 28455599Cao X, White PF, Ma H. An update on the management of postoperative nausea and vomiting. J Anesth. 2017 Aug;31(4):617-626. doi: 10.1007/s00540-017-2363-x. Epub 2017 Apr 28.
- Background: PubMed 30426190Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
- Background: PubMed 32778493Gecit S, Ozbayir T. Evaluation of Preoperative Risk Assessment and Postoperative Nausea and Vomiting: Importance for Nurses. J Perianesth Nurs. 2020 Dec;35(6):625-629. doi: 10.1016/j.jopan.2020.04.006. Epub 2020 Aug 7.
- Background: PubMed 10485781Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
- Background: PubMed 21307770American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.
- Preventable surgical harm in gynecologic oncology: optimizing quality and patient safety.Link provided by the sponsor.
- REVIEW OF STUDIES EVALUATING THE EFFECT OF AROMATHERAPY ON THE MANAGEMENT OF POSTOPERATIVE NAUSEA AND VOMITINGLink provided by the sponsor.
- POSTOPERATIVE NAUSEA AND VOMITINGLink provided by the sponsor.
- TSARLink provided by the sponsor.
- Individual participant dataSharing planned: No. Results regarding the relationship between APFEL risk score fasting times and PONV will be shared. However, personal information will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea, Postoperative and Vomiting, Postoperative, run by Cukurova 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 21 Aug 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the risk of posoperative nausea and vomiting. (time frame: 24 hours). 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?
On the ClinicalTrials.gov record for NCT06022705, which also lists 15 linked publications.
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 21 Aug 2024.