(QoRLowflow: Changes in Quality of Recovery With Low-Flow Anesthesia (QoRinLowflow)

Sponsor
Acibadem University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05773417
Collaborator
Ataturk University (Other)
50
1
27.9
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Changes in Quality of Recovery With Low-Flow Anesthesia in Minor ENT Surgery (QoRLowflow)
    Actual Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Apr 29, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Low Flow

    0.5 L/minute

    High Flow

    4 L/minute

    Outcome Measures

    Primary Outcome Measures

    1. 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. [Up to 2 days]

      This questionnaire consists of 40 questions with 5 different aspects; emotional state (9 questions), physical comfort (12 questions), psychological support (7 questions), physical independence (5 questions), pain (7 questions). Each question will be answered as 'never', 'sometimes', 'often', 'often', 'always' according to the Likert scale, according to the frequency of occurrence. Each frequency term will be scored from 1 to 5. The questionnaire has parts A and B. In part A, the questions indicate positive aspects, the higher the frequency of occurrence, the higher the score. In part B, the opposite is true. In Part A, 'never' is denoted by '1', 'sometimes' by '2', often' by 3, often' by '4', 'always' by '5' . In part B, 'never' is expressed with '5', sometimes', '4', and so on. The total score ranges from QoR-40 40 (poor compilation) to 200 points (excellent compilation).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Acıbadem Mehmet Ali Aydınlar University Istanbul Üsküdar Turkey 34600

    Sponsors and Collaborators

    • Acibadem University
    • Ataturk University

    Investigators

    • Principal Investigator: Serpil Z Ustalar, doctor, Acıbadem Mehmet Ali Aydınlar University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Acibadem University
    ClinicalTrials.gov Identifier:
    NCT05773417
    Other Study ID Numbers:
    • Recovery quality 2122
    First Posted:
    Mar 17, 2023
    Last Update Posted:
    Mar 17, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Acibadem University

    Study Results

    No Results Posted as of Mar 17, 2023