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Postoperative Nausea and VomitingNCT06390280

The Role of High Intraoperative Fraction of Inspired Oxygen in Preventing Postoperative Nausea and Vomiting

An observational study of Postoperative Nausea and Vomiting and Laparoscopic Cholecystectomy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postoperative nausea and vomiting is one of the most common complications after laparoscopic surgeries. The investigators aimed to evaluate the effects of intraoperative high fraction of inspired oxygen in preventing postoperative nausea and vomiting according to Apfel score in laparoscopic cholecystectomy patients. Read more about this study

Who is it for?
Ages Up to 60 years
What is being tested?
intraoperative Fraction of Inspired Oxygen
Type of treatment
Surgery or procedure
How many people
98 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jul 2022to 28 Feb 2023
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 Up to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: A total of 98 patients, under the age of 60, in the ASA I-II risk group, who underwent laparoscopic cholecystectomy surgery were included.

Who may be able to join

  • Patients undergoing elective laparoscopy cholecystectomy surgery
  • Patients younger than 60 years old
  • Both genders
  • American Society of Anesthesiologists (ASA) I-II risk group

Who cannot join

  • pregnancy, patients who do not want to participate in the study, surgery time > 2 hours

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital

    Ankara, Bilkent

Other trials in Turkey (Türkiye)

About this study

Official title: The Role of High Intraoperative Fraction of Inspired Oxygen in Preventing Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy

Postoperative nausea and vomiting is one of the most common complications after laparoscopic surgeries.

The investigators aimed to evaluate the effects of intraoperative high fraction of inspired oxygen in preventing postoperative nausea and vomiting according to Apfel score in laparoscopic cholecystectomy patients.

Read the detailed description

All participants will be monitored with electrocardiogram, pulse oximeter , non-invasive blood pressure. The fasting period of the patients was 8 hours. The participants were randomly divided into two groups by the auxiliary health personnel using the closed envelope draw method. After the participants were taken to the operating room, their files were checked, consent for the study was obtained, and the Apfel score was noted. Participants were started on intravenous crystalloid fluid infusion at 8ml/kg/hour. After induction of general anesthesia with 0.03mg/kg midazolam, 2-2.5 mg/kg propofol, 1 µg/kg remifentanil, 0.6 mg/kg rocuronium, the participants were intubated and connected to the anesthesia machine, with sevoflurane and maintenance administered at minimum alveolar concentration 1.3. was achieved with remifentanil infusion. After the participants were connected to the anesthesia device, the tidal volume was adjusted to 7 ml/kg, respiratory rate 12-14/min, positive end-expiratory pressure 5 cmH2O, flow 2 liter/min, Fraction of inspired oxygen 30% in Group I and 80% in Group 2. Gastric fluid and air were aspirated from the participants using an orogastric tube. The participants' vitals were monitored intraoperatively at 5-minute intervals and recorded every 15 minutes. Intra-abdominal pressure was kept between 10-12 mmHg. Approximately 15 minutes before the end of the surgical procedure, remifentanil infusion was stopped, and 1 g paracetamol and 50 mg dexketoprofen i.v. were administered as postoperative analgesics was given. No narcotic analgesics were given. At the end of the operation, exsufflation was performed before the trocars were removed and the intra-abdominal pressure was allowed to return to normal. The surgical team was given bupivacaine to administer 15 mg per trocar site. While the last few skin stitches were being placed, sevoflurane was discontinued in all participants and they were switched to 100% oxygen. Muscle relaxant antagonism was achieved with sugammadex (2 mg/kg) in both groups. The patients were extubated and monitored for 1 hour postoperatively in the recovery unit. All patients were given 2 liter/min O2 in the recovery unit. In case of nausea and vomiting, the Nausea Vomiting Score is noted and 4 mg of ondansetron i.v. is given to patients with moderate to severe nausea and vomiting. Participants requiring additional analgesics were given 100 mg tramadol. Postoperative 24-hour nausea and vomiting was monitored in the patient's hospitalization ward. The participants with nausea and vomiting during the 24-hour follow-up were learned from the follow-up doctor and noted on the follow-up forms. During the ward follow-up, patients with nausea were given 4mg of ondansetron.

Being tested
intraoperative Fraction of Inspired 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.

  • intraoperative Fraction of Inspired OxygenProcedure or surgery

    Group I intraoperative Fraction of Inspired Oxygen 30%, Group II intraoperative Fraction of Inspired Oxygen 80% applied group.

Study groups in NCT06390280
Study groupRoleWhat they receive
grup IIntraoperative Fraction of Inspired Oxygen %30 applied
Receives: Procedure: intraoperative Fraction of Inspired Oxygen
grup IIIntraoperative Fraction of Inspired Oxygen %80 applied
Receives: Procedure: intraoperative Fraction of Inspired Oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative nausea and vomiting

    the investigators aimed to compare postoperative nause and vomiting

    Measured: at the postoperative 15.minutes

  2. Postoperative nausea and vomiting 24.hours

    the investigators aimed to compare postoperative nause and vomiting

    Measured: at the postoperative 24.hours

Secondary outcomes (2)
  1. Postoperative antiemetic 15. minutes

    the investigators aimed to compare postoperative making antiemetic medication

    Measured: at the postoperative 15.minutes

  2. Postoperative antiemetic 24.hours

    the investigators aimed to compare postoperative making antiemetic medication

    Measured: at the postoperative 24.hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start10 Jul 2022
  3. Primary completion30 Jan 2023
  4. Study completion28 Feb 2023

Resources

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
98 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06390280
Sponsor's protocol ID
E2-22-2167
Status last verified
Apr 2024
First submitted
14 Nov 2023
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Nausea and Vomiting and Laparoscopic Cholecystectomy, run by Ankara City Hospital Bilkent 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 4 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: finished, as of the sponsor's last update on 30 Apr 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?

Postoperative nausea and vomiting (time frame: at the postoperative 15.minutes). 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 30 Apr 2024.

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