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

NCT ID: NCT05773417

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Low Flow Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low Flow

0.5 L/minute

No interventions assigned to this group

High Flow

4 L/minute

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role collaborator

Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Serpil Z Ustalar, doctor

Role: PRINCIPAL_INVESTIGATOR

Acıbadem Mehmet Ali Aydınlar University

Locations

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Acıbadem Mehmet Ali Aydınlar University

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Serpil Z Ustalar, doctor

Role: CONTACT

+905336663396

Merve Şeker, doctor

Role: CONTACT

+905315524681

Facility Contacts

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Serpil Z Ustalar, Doctor

Role: primary

+905336663396

Merve Şeker, Doctor

Role: backup

05315524681

References

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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.

Reference Type RESULT
PMID: 20601860 (View on PubMed)

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.

Reference Type RESULT
PMID: 21945921 (View on PubMed)

Other Identifiers

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Recovery quality 2122

Identifier Type: -

Identifier Source: org_study_id

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