NCT06203171

Brief Summary

Failure to properly manage the perioperative period of patients is associated with increased morbidity and mortality. Preoperative evaluation in patients planned for surgery contributes to reviewing possible perioperative risks, optimizing the patient's functional and physiological status, and reducing the possibility of perioperative complications. Assessments made during the preoperative evaluation process can be used to educate the patient, organize resources for perioperative care, and formulate plans for intraoperative care, postoperative recovery, and perioperative pain management. However, the effect of preoperative evaluation on patient outcomes has not been clearly demonstrated. In this study, the effect of preoperative anesthesia evaluation on perioperative complications was investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

January 2, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

Anesthesiapreoperative assesmentPerioperative complications

Outcome Measures

Primary Outcomes (2)

  • Perioperative hemodynamic complications

    New developments in the perioperative period hemodynamic complications 1. Hypertension; systolic arterial pressure \>160 mm Hg 2. Hypotension; mean arterial pressure \< 65 mmHg 3. Cardiac arrhythmia 4. Acute Coronary syndrome; ECG changes and/or cardiac enzyme elevation accompanied by chest pain

    Up to 24 hours

  • New developments in the perioperative period respiratuary complications

    Respiratory Failure; Oxygen saturation \< 90 or tachypnea (respiratory rate \> 20/min

    Up to 24 hours

Secondary Outcomes (1)

  • Time of hospital

    2 weeks

Study Arms (2)

Group C

Patients with perioperative complications

Other: Observational

Group non-C

Patients with no perioperative complications

Other: Observational

Interventions

Routine laboratory parameters requested from patients; Direct lung Radiograph and Electrocardiography results were evaluated and preoperative consultations and recommendations requested from the patients were recorded. Type of anesthesia, operation performed, operation duration, intraoperative blood and fluid losses, intraoperative and postoperative complications that develop within the first 24 hours, additional problems that develop (pain, postoperative nausea and vomiting, hypothermia, change of consciousness, bleeding and unplanned transfer to the intensive care unit). postanesthesia recovery The length of stay in the room, length of hospital stay, and method of discharge were recorded. The effects of preoperative laboratory, imaging methods and required consultations on intraoperative and postoperative complications in the first 24 hours were evaluated.

Group CGroup non-C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who will undergo elective surgery have been evaluated by an anesthesiologist at the anesthesia clinic before surgery and have completed the examinations and necessary consultations requested by the anesthesiologist.

You may qualify if:

  • Elective surgery
  • ASA ≤ 3 patients
  • Patients over 18 years of age

You may not qualify if:

  • Emergency surgeries
  • ASA \> 3 patients
  • Pregnant women
  • Age \> 80
  • Age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (5)

  • Rose J, Weiser TG, Hider P, Wilson L, Gruen RL, Bickler SW. Estimated need for surgery worldwide based on prevalence of diseases: a modelling strategy for the WHO Global Health Estimate. Lancet Glob Health. 2015 Apr 27;3 Suppl 2(Suppl 2):S13-20. doi: 10.1016/S2214-109X(15)70087-2.

    PMID: 25926315BACKGROUND
  • Siddaiah H, Patil S, Shelvan A, Ehrhardt KP, Stark CW, Ulicny K, Ridgell S, Howe A, Cornett EM, Urman RD, Kaye AD. Preoperative laboratory testing: Implications of "Choosing Wisely" guidelines. Best Pract Res Clin Anaesthesiol. 2020 Jun;34(2):303-314. doi: 10.1016/j.bpa.2020.04.006. Epub 2020 Apr 22.

    PMID: 32711836BACKGROUND
  • Colla CH, Morden NE, Sequist TD, Schpero WL, Rosenthal MB. Choosing wisely: prevalence and correlates of low-value health care services in the United States. J Gen Intern Med. 2015 Feb;30(2):221-8. doi: 10.1007/s11606-014-3070-z. Epub 2014 Nov 6.

    PMID: 25373832BACKGROUND
  • Beckerleg W, Kobewka D, Wijeysundera DN, Sood MM, McIsaac DI. Association of Preoperative Medical Consultation With Reduction in Adverse Postoperative Outcomes and Use of Processes of Care Among Residents of Ontario, Canada. JAMA Intern Med. 2023 May 1;183(5):470-478. doi: 10.1001/jamainternmed.2023.0325.

    PMID: 36972037BACKGROUND
  • Komurcu O, Genc C, Kurt BC, Demir O, Akbas A, Akyurt D, Kusderci HS, Tulgar S, Suren M. Preoperative evaluation: Impact on early perioperative hemodynamic and respiratory complications. BMC Anesthesiol. 2024 Nov 27;24(1):435. doi: 10.1186/s12871-024-02821-1.

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • OZGUR KOMURCU, 1

    Samsun University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 12, 2024

Study Start

October 15, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations