Clinical trial NCT05773417: Changes in Quality of Recovery With Low-Flow Anesthesia (QoRinLowflow)
Official title: Changes in Quality of Recovery With Low-Flow Anesthesia in Minor ENT Surgery (QoRLowflow)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Flow Anesthesia
Keywords: Low Flow Anesthesia
Quality of Recovery
Cognition Tests
Postoperative Complications
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2023-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary Care Clinic

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 0.07mg/kg intramuscularly 20 minutes before the operation. In both groups, anesthesia induction will be achieved with intravenous propofol 3 mg/kg, remifentanil 0.1 mic/kg, and rocuronium 0.06 mg/kg. Following endotracheal intubation, maintenance of anesthesia will be provided to the patients in Group I by inhalation, with sevoflurane MAC 1 in O2/Air 1/3 (4lt/min). On the other hand, patients in Group II will be switched to O2/Air 0.16/0.48 (0.5 lt/min) low flow anesthesia 15 minutes after the depth of anesthesia is provided (BIS\<50) and inhalation anesthesia starts. Remifentanil infusion will be administered intravenously at 0.025-0.1 mic/kg/min to all patients in both groups for peroperative analgesia. For postoperative analgesia, fentanyl will be administered intravenously as 2 mic/kg 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, inspiratory/expiratory oxygen/air/sevoflurane 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 mg/kg. 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. Nausea/vomiting 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.

Eligibility criteria: Inclusion Criteria:

1. Cases in which general anesthesia will be applied by intubation and anesthesia will be maintained with inhalation anesthetics;
2. 2 - 6 hour cases
3. 18 - 60 years old
4. Low flow anesthesia application with 0.5 lt/min flow rate
5. Patients undergoing muscular recovery with sugammadex

Exclusion Criteria:

1. Patients with bleeding diathesis or patients with bleeding in excess of 400 ml
2. Patients with mental/neurological problems
3. Patients who refused to participate in the study and could not respond
4. Patients who cannot apply low current
5. Uncooperative patients with delirium
6. Hypotension in perioperative parameters (MAP \< 40 mmHg)
7. Patients with diabetic ketoacidosis
8. Cases taken when soda lime is dry

Primary outcomes:
measure: The effect of low-flow anesthesia applications on the quality of patient recovery by evaluating the 'Quality of Recovery' performed in the early postoperative period.
timeFrame: Up to 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Mehmet Ali Aydınlar University
state: Üsküdar
Study officials:
affiliation: Acıbadem Mehmet Ali Aydınlar University
name: Serpil Z Ustalar, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.
citation: Jakobsson J. Assessing recovery after ambulatory anaesthesia, measures of resumption of activities of daily living. Curr Opin Anaesthesiol. 2011 Dec;24(6):601-4. doi: 10.1097/ACO.0b013e32834c3916.