Clinical trial NCT06390280: The Role of High Intraoperative Fraction of Inspired Oxygen in Preventing Postoperative Nausea and Vomiting
Official title: The Role of High Intraoperative Fraction of Inspired Oxygen in Preventing Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Nausea and Vomiting
Laparoscopic Cholecystectomy
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 98
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: at the postoperative 15.minutes
measure: Postoperative nausea and vomiting 24.hours
timeFrame: at the postoperative 24.hours
Secondary outcomes:
measure: Postoperative antiemetic 15. minutes
timeFrame: at the postoperative 15.minutes
measure: Postoperative antiemetic 24.hours
timeFrame: at the postoperative 24.hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Bilkent
Study officials:
References: