Low Flow Anesthesia(QoRLowflowNCT05773417
Changes in Quality of Recovery With Low-Flow Anesthesia (QoRinLowflow)
An observational study of Low Flow Anesthesia, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Flow Anesthesia
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary Care Clinic
Who may be able to join
- Cases in which general anesthesia will be applied by intubation and anesthesia will be maintained with inhalation anesthetics;
- 2 - 6 hour cases
- 18 - 60 years old
- Low flow anesthesia application with 0.5 lt/min flow rate
- Patients undergoing muscular recovery with sugammadex
Who cannot join
- Patients with bleeding diathesis or patients with bleeding in excess of 400 ml
- Patients with mental/neurological problems
- Patients who refused to participate in the study and could not respond
- Patients who cannot apply low current
- Uncooperative patients with delirium
- Hypotension in perioperative parameters (MAP < 40 mmHg)
- Patients with diabetic ketoacidosis
- Cases taken when soda lime is dry
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acıbadem Mehmet Ali Aydınlar University
Istanbul, Üsküdar, 34600
Serpil Z Ustalar, Doctor, +905336663396, serpozgen@gmail.com
Merve Şeker, Doctor, 05315524681, merbal_@hotmail.com
About this study
Official title: Changes in Quality of Recovery With Low-Flow Anesthesia in Minor ENT Surgery (QoRLowflow)
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.
Read the 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.
- Conditions
- Low Flow Anesthesia
- Keywords
- Low Flow Anesthesia, Quality of Recovery, Cognition Tests, Postoperative Complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low Flow | 0.5 L/minute | |
| High Flow | 4 L/minute |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: Up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Jan 2021
- Primary completion29 Apr 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Flow AnesthesiaStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor
- Investigators
- Serpil Z Ustalar, doctor, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773417
- Sponsor's protocol ID
- Recovery quality 2122
- Acronym
- (QoRLowflow
- Status last verified
- Mar 2023
- First submitted
- 18 Jan 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20601860Jakobsson 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.
PubMed 21945921
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Quality of Recovery With Low-Flow Anesthesia in Minor ENT Surgery (QoRLowflow)
- ClinicalTrials.gov ID
- NCT05773417
- Acronym / sponsor ID
- (QoRLowflow / Recovery quality 2122
- Conditions
- Low Flow Anesthesia
- Keywords
- Low Flow Anesthesia, Quality of Recovery, Cognition Tests, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 29 Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Flow | – | –0.5 L/minute |
| High Flow | – | –4 L/minute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary Care Clinic
Key inclusion criteria (5 listed)
- Cases in which general anesthesia will be applied by intubation and anesthesia will be maintained with inhalation anesthetics;
- 2 - 6 hour cases
- 18 - 60 years old
- Low flow anesthesia application with 0.5 lt/min flow rate
- Patients undergoing muscular recovery with sugammadex
Key exclusion criteria (8 listed)
- Patients with bleeding diathesis or patients with bleeding in excess of 400 ml
- Patients with mental/neurological problems
- Patients who refused to participate in the study and could not respond
- Patients who cannot apply low current
- Uncooperative patients with delirium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Results publication: PubMed 20601860Royse 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.
- Results publication: PubMed 21945921Jakobsson 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.
- Individual participant dataSharing planned: No
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Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serpil Z Ustalar, doctor principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Flow Anesthesia, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serpil Z Ustalar, doctor (+905336663396, serpozgen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Up to 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05773417, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.