Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06390280 |
| Other study ID # |
E2-22-2167 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 10, 2022 |
| Est. completion date |
February 28, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Ankara City Hospital Bilkent |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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.
