NCT05773417

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

January 18, 2023

Last Update Submit

March 6, 2023

Conditions

Low Flow Anesthesia

Keywords

Low Flow AnesthesiaQuality of RecoveryCognition TestsPostoperative Complications

Outcome Measures

Primary Outcomes (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.

    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).

    Up to 2 days

Study Arms (2)

Low Flow

0.5 L/minute

High Flow

4 L/minute

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Tertiary Care Clinic

You may qualify if:

  • Cases in which general anesthesia will be applied by intubation and anesthesia will be maintained with inhalation anesthetics;
  • hour cases
  • years old
  • Low flow anesthesia application with 0.5 lt/min flow rate
  • Patients undergoing muscular recovery with sugammadex

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Mehmet Ali Aydınlar University

Istanbul, Üsküdar, 34600, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 20601860RESULT

  • 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.

    PMID: 21945921RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Serpil Z Ustalar, doctor

    Acıbadem Mehmet Ali Aydınlar University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serpil Z Ustalar, doctor

CONTACT

+905336663396serpozgen@gmail.com

Merve Şeker, doctor

CONTACT

+905315524681merbal_@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2023

First Posted

March 17, 2023

Study Start

January 1, 2021

Primary Completion

April 29, 2023

Study Completion

May 1, 2023

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)