Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773417
Status:
RECRUITING
Last Update Posted:
2023-03-17
First Post:
2023-01-18
Brief Title:
Changes in Quality of Recovery With Low-Flow Anesthesia QoRinLowflow
Sponsor:
Acibadem University
Organization:
Acibadem University
Study Overview
Official Title:
Changes in Quality of Recovery With Low-Flow Anesthesia in Minor ENT Surgery QoRLowflow
Status:
RECRUITING
Status Verified Date:
2023-03
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:
QoRLowflow
Brief Summary:
Postoperative recovery quality is as important as patient satisfaction and clinical results in terms of a fast and high-quality surgical process This study was conducted to investigate the effect of low-flow anesthesia applications on the quality of patient recovery by evaluating the Quality of Recovery QoR40 test and the perception tests PQRS Cognitive test performed in the early postoperative period
Detailed Description:
All patients will be evaluated preoperatively in the anesthesia outpatient clinic their consent will be obtained and they will be informed about the Postoperative Recovery Evaluation and pre-tests will be performed All patients will receive premedication midazolam 007mgkg intramuscularly 20 minutes before the operation In both groups anesthesia induction will be achieved with intravenous propofol 3 mgkg remifentanil 01 mickg and rocuronium 006 mgkg Following endotracheal intubation maintenance of anesthesia will be provided to the patients in Group I by inhalation with sevoflurane MAC 1 in O2Air 13 4ltmin On the other hand patients in Group II will be switched to O2Air 016048 05 ltmin low flow anesthesia 15 minutes after the depth of anesthesia is provided BIS50 and inhalation anesthesia starts Remifentanil infusion will be administered intravenously at 0025-01 mickgmin to all patients in both groups for peroperative analgesia For postoperative analgesia fentanyl will be administered intravenously as 2 mickg 10 minutes before the end of the surgery In group I patients remifentanil infusion and inhalation anesthesia will be reduced and stopped at the end of surgery BIS maximum 60 In patients in Group II inhalation anesthesia will be terminated 15 minutes before the end of surgery and remifentanil infusion will be terminated with the last suture BIS maximum 60 Peroperatively patients heart rate mean blood pressure oxygen saturation with pulse oximetry tidal volume respiratory rate inspiratoryexpiratory oxygenairsevoflurane concentrations leakage amounts end tidal CO2 and inspiratory CO2 amounts BIS values will be recorded at 15-minute intervals The end of the surgery the last suture of the surgery the end of the anesthesia will be recorded as the termination of the administration of intravenous and inhalation anesthetics Muscle laxity of the patients will be restored with sugammadex 2 mgkg As the extubation criteria the spontaneous ventilation of the patients with sufficient tidal volume and the end of muscle relaxation will be taken as BIS 70 The extubation time will be recorded Postoperative recovery evaluations of the patients will be made Nauseavomiting and Modified Aldrete scores and VAS values of the patients followed for 30 minutes in the recovery unit will be recorded At the end of the first 30 minutes PQRS Cognitive test will be applied to the patients On the morning of the first postoperative day the QoR40 test will be applied and scored by an anesthesia technician who does not know the anesthesia method The results will be compared
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