Post Operative PainNCT05961722
Preoperative Intravenous Fluid Type and Postoperative Nausea
An observational study of Post Operative Pain and Nausea and Vomiting, Postoperative, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to investigate the relationship between postoperative nausea and vomiting, anxiety levels and pain scores in the postoperative period according to dosing and choosing of intravenous fluid type that the patients received in the preoperative period. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Operative Pain, Nausea and Vomiting, Postoperative, Anxiety
- What is being tested?
- preoperative IV 0.9% saline 400 ml, preoperative dextrose 5% 400 ml and preoperative and intraoperative dextrose 5% 400 ml
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 5 Aug 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 90 ASA I-II patients who will undergo laparoscopic cholecystectomy surgery will be included in the study and will be divided into three equal groups.
Who may be able to join
- Patients who underwent laparoscopic cholecystectomy
- Patients over the age of 18
Who cannot join
- Patients who do not accept the study
- Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170
About this study
Official title: The Effect of Choosing of Preoperative Intravenous Fluid Type on the Postoperative Nausea, Vomiting, Anxiety and Pain After Laparoscopic Cholecystectomy
In this study, it was aimed to investigate the relationship between postoperative nausea and vomiting, anxiety levels and pain scores in the postoperative period according to dosing and choosing of intravenous fluid type that the patients received in the preoperative period.
Read the detailed description
Fluid management is an integral and important part of perioperative treatment. In order to prevent organ damage, a key components of assuring adequate organ perfusion is to provide adequate volume and appropriate fluid. Types of the fluids, amount of the fluid given and timing of the administration are the main topics that determine the fluid management strategy. Colloids (e.g. albumin or fresh frozen plasma (FFP)) and crystalloids (e.g. ringer lactate, isotonic, 5% dextrose) are types of intravenous fluids that are used for fluid replacement apart from blood transfusion . Crystalloids are low-cost salt solutions with small molecules, which can move around easily when injected into the body.
There are studies reporting that fluid therapy applied in the preoperative period reduces gastric acid secretion and reduces stomach movements and nausea and vomiting. In addition, there are studies reporting that fluids given in the preoperative period have a positive effect on anxiety levels by reducing the feeling of hunger and thirst in patients. There are studies reporting that fluid therapy reduces ATP destruction and oxidative stress, which contributes to the reduction of pain levels.
90 ASA I-II patients who will undergo laparoscopic cholecystectomy surgery will be included in the study and will be divided into three equal groups. Patients in Group 1 were administered 400 ml 0.9% saline infusion within 30 minutes, 2 hours before surgery. Patients in Group 2 were infused with 400 ml 5% Dextrose at the same infusion rate. In groups 1 and 2, 10 ml/kg/h 0.9% saline infusion was applied during the intraoperative period. Patients in Group 3 were administered 200 ml dextrose infusion in the preoperative period and 200 ml dextrose infusion in the intraoperative period. 0.9% saline infusion was applied so that the total intraoperative fluid volume was the same as in the other groups.
Postoperative nausea and vomiting (PONV) , within 24 hours was compared between groups by PONV score. Other outcomes were the antiemetic drugs needed, The NRS Score, The State-Trait Anxiety Inventory , additional analgesic drug requirement.
In this study, it was aimed to investigate the relationship between postoperative nausea and vomiting, anxiety levels and pain scores in the postoperative period according to dosing and choosing of intravenous fluid type that the patients received in the preoperative period.
- Being tested
- preoperative IV 0.9% saline 400 ml, preoperative dextrose 5% 400 ml, preoperative and intraoperative dextrose 5% 400 ml
- Keywords
- preoperative intravenous fluid type, laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative IV 0.9% saline 400 mlOther
Group 1 will be infused with IV 0.9% saline 400 mL.
preoperative dextrose 5% 400 mlOther
Group 2 will be infused with dextrose 5% Dekstroz 400 ml.
preoperative and intraoperative dextrose 5% 400 mlOther
Group 3 will be infused with dextrose preoperative 200 ml and intraoperative 200 ml 5% dextrose infusion.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group receiving preoperative and intraoperative saline infusion. Receives: Other: preoperative IV 0.9% saline 400 ml | |
| Group 2 | The group receiving preoperative dextrose and intraoperative saline infusion. Receives: Other: preoperative dextrose 5% 400 ml | |
| Group 3 | The group receiving preoperative and intraoperative dextrose infusion. Receives: Other: preoperative and intraoperative dextrose 5% 400 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV Score
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy.
- 0=no PONV: patient reports no nausea and has had no emesis episodes;
- 1=mild PONV: patient reports nausea but declines antiemetic treatment;
- 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and
- 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
Measured: 0 hours postoperatively
PONV Score
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy.
- 0=no PONV: patient reports no nausea and has had no emesis episodes;
- 1=mild PONV: patient reports nausea but declines antiemetic treatment;
- 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and
- 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
Measured: 2 hours postoperatively
PONV Score
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy.
- 0=no PONV: patient reports no nausea and has had no emesis episodes;
- 1=mild PONV: patient reports nausea but declines antiemetic treatment;
- 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and
- 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
Measured: 4 hours postoperatively
PONV Score
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy.
- 0=no PONV: patient reports no nausea and has had no emesis episodes;
- 1=mild PONV: patient reports nausea but declines antiemetic treatment;
- 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and
- 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
Measured: 8 hours postoperatively
PONV Score
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy.
- 0=no PONV: patient reports no nausea and has had no emesis episodes;
- 1=mild PONV: patient reports nausea but declines antiemetic treatment;
- 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and
- 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
Measured: 12 hours postoperatively
PONV Score
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy.
- 0=no PONV: patient reports no nausea and has had no emesis episodes;
- 1=mild PONV: patient reports nausea but declines antiemetic treatment;
- 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and
- 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
Measured: 24 hours postoperatively
Secondary outcomes (8)
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 0 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 2 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 4 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 8 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 12 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 24 hours postoperatively
State-Trait Anxiety Inventory ( The STAI )
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: 2 hours before induction of anesthesia
State-Trait Anxiety Inventory ( The STAI )
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: 0 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Oct 2023
- Primary completion1 Feb 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf Özgüner, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961722
- Sponsor's protocol ID
- AnkaraEtlikYusufOzguner003
- Status last verified
- Sep 2024
- First submitted
- 13 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoorn EJ. Intravenous fluids: balancing solutions. J Nephrol. 2017 Aug;30(4):485-492. doi: 10.1007/s40620-016-0363-9. Epub 2016 Nov 29.
PubMed 27900717Agarwal A, Dhiraaj S, Tandon M, Singh PK, Singh U, Pawar S. Evaluation of capsaicin ointment at the Korean hand acupressure point K-D2 for prevention of postoperative nausea and vomiting. Anaesthesia. 2005 Dec;60(12):1185-8. doi: 10.1111/j.1365-2044.2005.04402.x.
PubMed 16288616Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.
PubMed 11682427Kristoffersen L, Malahleha M, Duze Z, Tegnander E, Kapongo N, Stoen R, Follestad T, Eik-Nes SH, Bergseng H. Randomised controlled trial showed that neonates received better pain relief from a higher dose of sucrose during venepuncture. Acta Paediatr. 2018 Dec;107(12):2071-2078. doi: 10.1111/apa.14567. Epub 2018 Oct 2.
PubMed 30188590
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Choosing of Preoperative Intravenous Fluid Type on the Postoperative Nausea, Vomiting, Anxiety and Pain After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05961722
- Acronym / sponsor ID
- AnkaraEtlikYusufOzguner003
- Keywords
- preoperative intravenous fluid type, laparoscopic cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 27 Jul 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.
In this study, it was aimed to investigate the relationship between postoperative nausea and vomiting, anxiety levels and pain scores in the postoperative period according to dosing and choosing of intravenous fluid type that the patients received in the preoperative period.
Detailed description
Fluid management is an integral and important part of perioperative treatment. In order to prevent organ damage, a key components of assuring adequate organ perfusion is to provide adequate volume and appropriate fluid. Types of the fluids, amount of the fluid given and timing of the administration are the main topics that determine the fluid management strategy. Colloids (e.g. albumin or fresh frozen plasma (FFP)) and crystalloids (e.g. ringer lactate, isotonic, 5% dextrose) are types of intravenous fluids that are used for fluid replacement apart from blood transfusion . Crystalloids are low-cost salt solutions with small molecules, which can move around easily when injected into the body.
There are studies reporting that fluid therapy applied in the preoperative period reduces gastric acid secretion and reduces stomach movements and nausea and vomiting. In addition, there are studies reporting that fluids given in the preoperative period have a positive effect on anxiety levels by reducing the feeling of hunger and thirst in patients. There are studies reporting that fluid therapy reduces ATP destruction and oxidative stress, which contributes to the reduction of pain levels.
90 ASA I-II patients who will undergo laparoscopic cholecystectomy surgery will be included in the study and will be divided into three equal groups. Patients in Group 1 were administered 400 ml 0.9% saline infusion within 30 minutes, 2 hours before surgery. Patients in Group 2 were infused with 400 ml 5% Dextrose at the same infusion rate. In groups 1 and 2, 10 ml/kg/h 0.9% saline infusion was applied during the intraoperative period. Patients in Group 3 were administered 200 ml dextrose infusion in the preoperative period and 200 ml dextrose infusion in the intraoperative period. 0.9% saline infusion was applied so that the total intraoperative fluid volume was the same as in the other groups.
Postoperative nausea and vomiting (PONV) , within 24 hours was compared between groups by PONV score. Other outcomes were the antiemetic drugs needed, The NRS Score, The State-Trait Anxiety Inventory , additional analgesic drug requirement.
In this study, it was aimed to investigate the relationship between postoperative nausea and vomiting, anxiety levels and pain scores in the postoperative period according to dosing and choosing of intravenous fluid type that the patients received in the preoperative period.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: preoperative IV 0.9% saline 400 mlGroup receiving preoperative and intraoperative saline infusion. |
| Group 2 | – | Other: preoperative dextrose 5% 400 mlThe group receiving preoperative dextrose and intraoperative saline infusion. |
| Group 3 | – | Other: preoperative and intraoperative dextrose 5% 400 mlThe group receiving preoperative and intraoperative dextrose infusion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 90 ASA I-II patients who will undergo laparoscopic cholecystectomy surgery will be included in the study and will be divided into three equal groups.
Key inclusion criteria (2 listed)
- Patients who underwent laparoscopic cholecystectomy
- Patients over the age of 18
Key exclusion criteria (2 listed)
- Patients who do not accept the study
- Diabetes Mellitus
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 |
|---|---|---|
| preoperative IV 0.9% saline 400 mlGroup 1 will be infused with IV 0.9% saline 400 mL. | Other | Group 1 |
| preoperative dextrose 5% 400 mlGroup 2 will be infused with dextrose 5% Dekstroz 400 ml. | Other | Group 2 |
| preoperative and intraoperative dextrose 5% 400 mlGroup 3 will be infused with dextrose preoperative 200 ml and intraoperative 200 ml 5% dextrose infusion. | Other | Group 3 |
Primary outcome
PONV Score
Time frame: 0 hours postoperatively
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy. * 0=no PONV: patient reports no nausea and has had no emesis episodes; * 1=mild PONV: patient reports nausea but declines antiemetic treatment; * 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and * 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
PONV Score
Time frame: 2 hours postoperatively
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy. * 0=no PONV: patient reports no nausea and has had no emesis episodes; * 1=mild PONV: patient reports nausea but declines antiemetic treatment; * 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and * 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
PONV Score
Time frame: 4 hours postoperatively
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy. * 0=no PONV: patient reports no nausea and has had no emesis episodes; * 1=mild PONV: patient reports nausea but declines antiemetic treatment; * 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and * 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
PONV Score
Time frame: 8 hours postoperatively
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy. * 0=no PONV: patient reports no nausea and has had no emesis episodes; * 1=mild PONV: patient reports nausea but declines antiemetic treatment; * 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and * 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
PONV Score
Time frame: 12 hours postoperatively
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy. * 0=no PONV: patient reports no nausea and has had no emesis episodes; * 1=mild PONV: patient reports nausea but declines antiemetic treatment; * 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and * 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
PONV Score
Time frame: 24 hours postoperatively
Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy. * 0=no PONV: patient reports no nausea and has had no emesis episodes; * 1=mild PONV: patient reports nausea but declines antiemetic treatment; * 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and * 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
8 secondary outcomes
Pain on the Numeric Rating Scale (NRS)
Time frame: 0 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time frame: 2 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time frame: 4 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time frame: 8 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time frame: 12 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time frame: 24 hours postoperatively
State-Trait Anxiety Inventory ( The STAI )
Time frame: 2 hours before induction of anesthesia
State-Trait Anxiety Inventory ( The STAI )
Time frame: 0 hours postoperatively
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 19 Sep 2024.
- Results publication: PubMed 27900717Hoorn EJ. Intravenous fluids: balancing solutions. J Nephrol. 2017 Aug;30(4):485-492. doi: 10.1007/s40620-016-0363-9. Epub 2016 Nov 29.
- Results publication: PubMed 16288616Agarwal A, Dhiraaj S, Tandon M, Singh PK, Singh U, Pawar S. Evaluation of capsaicin ointment at the Korean hand acupressure point K-D2 for prevention of postoperative nausea and vomiting. Anaesthesia. 2005 Dec;60(12):1185-8. doi: 10.1111/j.1365-2044.2005.04402.x.
- Results publication: PubMed 11682427Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.
- Results publication: PubMed 30188590Kristoffersen L, Malahleha M, Duze Z, Tegnander E, Kapongo N, Stoen R, Follestad T, Eik-Nes SH, Bergseng H. Randomised controlled trial showed that neonates received better pain relief from a higher dose of sucrose during venepuncture. Acta Paediatr. 2018 Dec;107(12):2071-2078. doi: 10.1111/apa.14567. Epub 2018 Oct 2.
- Individual participant dataSharing planned: No
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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 Post Operative Pain and Nausea and Vomiting, Postoperative, run by Ankara Etlik City Hospital 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 2 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 19 Sep 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?
PONV Score (time frame: 0 hours postoperatively). The study lists 6 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 NCT05961722, which also lists 4 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 19 Sep 2024.