Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390280
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-11-14
Brief Title:
The Role of High Intraoperative Fraction of Inspired Oxygen in Preventing Postoperative Nausea and Vomiting
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
The Role of High Intraoperative Fraction of Inspired Oxygen in Preventing Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 8mlkghour After induction of general anesthesia with 003mgkg midazolam 2-25 mgkg propofol 1 µgkg remifentanil 06 mgkg rocuronium the participants were intubated and connected to the anesthesia machine with sevoflurane and maintenance administered at minimum alveolar concentration 13 was achieved with remifentanil infusion After the participants were connected to the anesthesia device the tidal volume was adjusted to 7 mlkg respiratory rate 12-14min positive end-expiratory pressure 5 cmH2O flow 2 litermin 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 iv 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 mgkg in both groups The patients were extubated and monitored for 1 hour postoperatively in the recovery unit All patients were given 2 litermin O2 in the recovery unit In case of nausea and vomiting the Nausea Vomiting Score is noted and 4 mg of ondansetron iv 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None