Postoperative Nausea and VomitingNCT06197659
Effect of Liberal and Restrictive Fluids on Nausea-vomiting
A study testing Liberal Fluid Grubu and Restrictive Fluid Group in people with Postoperative Nausea and Vomiting, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients planned for laparoscopic cholecystectomy will be included in this study. The effects of liberal and restrictive fluid regimens given peroperatively to patients undergoing laparoscopic cholecystectomy will be compared on postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Liberal Fluid Grubu and Restrictive Fluid Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 15 Feb 2024
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients planned for laparoscopic cholecystectomy
- Patients aged 18-70
Who cannot join
- Congestive heart failure.
- Diabetes.
- Epilepsy.
- Heart valve disease.
- They are pregnant.
- Chronic liver disease.
- Chronic kidney disease. Chronic gastrointestinal tract disease. Those who used antiemetic drugs within 24 hours before surgery. Those who developed intraoperative hypertension. Those who develop excessive blood loss. Patients whose surgery procedure takes more than 2 hours.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Taining and Research Hospital
Karaman, 70200
About this study
Official title: The Effect of Peroperative Restrictive and Liberal Fluid Regimens on Postoperative Nausea-vomiting and Quality of Recovery in Laparoscopic Cholecystectomy: a Prospective Randomized Study.
Patients planned for laparoscopic cholecystectomy will be included in this study. The effects of liberal and restrictive fluid regimens given peroperatively to patients undergoing laparoscopic cholecystectomy will be compared on postoperative nausea and vomiting. The aim of this study is to investigate which regimen is more effective on postoperative nausea and vomiting in laparoscopic cholecystectomy.
Read the detailed description
Postoperative nausea and vomiting (PONV) is a common and disturbing side effect of anesthesia and surgery, and while its incidence in all surgical procedures varies between 20-77% if antiemetic prophylaxis is not applied, this rate is even higher in people prone to vomiting, such as cyclic vomiting syndrome . Its incidence varies between 53 - 72%, especially in patients undergoing laparoscopic cholecystectomy surgery, if antiemetic prophylaxis is not administered.
Since most existing antiemetics are expensive and cannot completely eliminate PONV, pharmacological PONV prophylaxis may not be cost-effective. For this reason, the incidence of PONV can be reduced by increasing the amount of inexpensive fluid used during surgery instead of prophylactic drug treatment. There are several studies investigating the effect of different perioperative fluid administration schemes on PONV in the adult population, especially in patients undergoing laparoscopic cholecystectomy or gynecological surgery, with variable results.
Based on this point, the inestigetors wanted to examine the effect of perioperative liberal and restrictive fluid treatments on PONV in patients who underwent laparoscopic cholecystectomy.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Liberal Fluid Grubu, Restrictive Fluid Group
- Keywords
- Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
- 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.
Liberal Fluid GrubuOther
Also called Liberal group
Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively.
Restrictive Fluid GroupOther
Also called Restrictive group
Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively.
| Study group | Role | What they receive |
|---|---|---|
| Liberal Fluid Group | Active comparator | Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively. Receives: Other: Liberal Fluid Grubu |
| Restrictive Fluid Group | Sham comparator | Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively. Receives: Other: Restrictive Fluid Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea-vomiting
Incidence of nausea and vomiting within 24 hours after surgery. The presence of at least one episode of nausea, retching and vomiting in the first 24 hours postoperatively will be considered a positive result.
Measured: Postoperative 24 hours
Quality of recovery
Quality of recovery will be evaluated at the 24th hour using the QoR-15 scale. It is a scale consisting of 15 questions and scoring from 0 to 10 for each question. 0 represents the worst and 150 represents the best recovery quality.
Measured: Postoperative 24 hours
Secondary outcomes (4)
Time to first antiemetic request
Time to first antiemetic request within 24 hours after surgery
Measured: Postoperative 24 hours
Time to request first oral drink
Time to request first oral drink within 24 hours after surgery
Measured: Postoperative 24 hours
First mobilization time
First mobilization time after surgery
Measured: Postoperative 24 hours
Total amount of analgesic
Total amount of rescue analgesic (tramadol) in the 24 hours after surgery
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Jan 2024
- Primary completion10 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two group; 1. Experimental Group: Group L; Liberal Fluid Group; Peroperative 20 mL/kg/h intravenous ringer lactate will be administered. 2. Sham Comparator: Group R; Restrictive Fluid Group; Peroperative 5 mL/kg/h intravenous ringer lactate will be administered.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muhammet korkusuz, Karaman Training and Research Hospital
- Investigators
- Muhammet Korkusuz, Principal investigator, Karamanoglu Mehmetbey University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197659
- Sponsor's protocol ID
- 10-2023/14
- Status last verified
- Feb 2024
- First submitted
- 12 Dec 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peroperative Restrictive and Liberal Fluid Regimens on Postoperative Nausea-vomiting and Quality of Recovery in Laparoscopic Cholecystectomy: a Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT06197659
- Acronym / sponsor ID
- 10-2023/14
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 9 Jan 2024 (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.
Patients planned for laparoscopic cholecystectomy will be included in this study. The effects of liberal and restrictive fluid regimens given peroperatively to patients undergoing laparoscopic cholecystectomy will be compared on postoperative nausea and vomiting. The aim of this study is to investigate which regimen is more effective on postoperative nausea and vomiting in laparoscopic cholecystectomy.
Detailed description
Postoperative nausea and vomiting (PONV) is a common and disturbing side effect of anesthesia and surgery, and while its incidence in all surgical procedures varies between 20-77% if antiemetic prophylaxis is not applied, this rate is even higher in people prone to vomiting, such as cyclic vomiting syndrome . Its incidence varies between 53 - 72%, especially in patients undergoing laparoscopic cholecystectomy surgery, if antiemetic prophylaxis is not administered.
Since most existing antiemetics are expensive and cannot completely eliminate PONV, pharmacological PONV prophylaxis may not be cost-effective. For this reason, the incidence of PONV can be reduced by increasing the amount of inexpensive fluid used during surgery instead of prophylactic drug treatment. There are several studies investigating the effect of different perioperative fluid administration schemes on PONV in the adult population, especially in patients undergoing laparoscopic cholecystectomy or gynecological surgery, with variable results.
Based on this point, the inestigetors wanted to examine the effect of perioperative liberal and restrictive fluid treatments on PONV in patients who underwent laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two group; 1. Experimental Group: Group L; Liberal Fluid Group; Peroperative 20 mL/kg/h intravenous ringer lactate will be administered. 2. Sham Comparator: Group R; Restrictive Fluid Group; Peroperative 5 mL/kg/h intravenous ringer lactate will be administered.
| Arm | Type | Receives |
|---|---|---|
| Liberal Fluid Group | Active comparator | Other: Liberal Fluid GrubuPatients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively. |
| Restrictive Fluid Group | Sham comparator | Other: Restrictive Fluid GroupPatients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients planned for laparoscopic cholecystectomy
- Patients aged 18-70
Key exclusion criteria (7 listed)
- Congestive heart failure.
- Diabetes.
- Epilepsy.
- Heart valve disease.
- They are pregnant.
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 |
|---|---|---|
| Liberal Fluid GrubuAlso: Liberal groupPatients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively. | Other | Liberal Fluid Group |
| Restrictive Fluid GroupAlso: Restrictive groupPatients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively. | Other | Restrictive Fluid Group |
Primary outcome
Incidence of postoperative nausea-vomiting
Time frame: Postoperative 24 hours
Incidence of nausea and vomiting within 24 hours after surgery. The presence of at least one episode of nausea, retching and vomiting in the first 24 hours postoperatively will be considered a positive result.
Quality of recovery
Time frame: Postoperative 24 hours
Quality of recovery will be evaluated at the 24th hour using the QoR-15 scale. It is a scale consisting of 15 questions and scoring from 0 to 10 for each question. 0 represents the worst and 150 represents the best recovery quality.
4 secondary outcomes
Time to first antiemetic request
Time frame: Postoperative 24 hours
Time to request first oral drink
Time frame: Postoperative 24 hours
First mobilization time
Time frame: Postoperative 24 hours
Total amount of analgesic
Time frame: Postoperative 24 hours
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 16 Feb 2024.
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Muhammet Korkusuz principal investigator
Karamanoglu Mehmetbey University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberal Fluid Grubu and Restrictive Fluid Group in people with Postoperative Nausea and Vomiting, run by Karaman Training and Research 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 7 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 16 Feb 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. Some participants in this study may receive a placebo. 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?
Incidence of postoperative nausea-vomiting (time frame: Postoperative 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?
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 16 Feb 2024.