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CompletedNCT06203171Updated Apr 19, 2024

Preoperative Evaluation on Perioperative Complications

An observational study in Perioperative Complication, sponsored by Samsun University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Samsun University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Not managing patients well before, during, and after surgery can lead to more health problems and deaths. In wealthy countries, 3-16% of patients face major issues during this time, and 0.4-0.8% of them might end up permanently disabled or dead. Checking patients before surgery helps identify risks, improves their health and fitness, and lowers the chances of problems during this period.

On another note, even though the right surgeries can save lives and prevent injuries, the growing cost of healthcare is a big issue worldwide. In the United States, the rising cost is a concern for everyone, including insurance companies and drug makers. It's believed that treatments that don't really help could be causing about 30% of these high costs.

No matter the surgery, patient's health, or anesthesia plan, checking patients before surgery is key to safe anesthesia for people of all ages. A thorough check before surgery helps manage patient care during this period, prevents surgery cancellations due to patient issues, and helps keep the surgery schedule efficient and cost-effective.

There's no agreed-upon definition for checking patients before anesthesia in medical literature. This check involves looking at the patient's medical history, interviews, physical exams, and test results. Anesthesiologists might also talk to other healthcare workers for more information or help with anesthesia care during this period. The information gathered can help educate the patient, plan for care during and after surgery, and manage pain.

However, it's not clear how much these pre-surgery checks actually improve patient outcomes. A recent study found that seeing a doctor before surgery didn't reduce, but actually increased, the chances of problems after surgery. This study looks at how well pre-surgery anesthesia checks at our center help prevent problems during this period

02

Conditions studied

  • Perioperative Complication

Keywords

  • Anesthesia
  • preoperative assesment
  • Perioperative complications
03

In context

Lead sponsor

Samsun University is the lead sponsor of 81 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Probability 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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Emergency surgeries
  • ASA > 3 patients
  • Pregnant women
  • Age > 80
  • Age \< 18
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Target follow-up
14 Days
Patient registry
Yes

Groups and cohorts

  • Group C

    Patients with perioperative complications

    Other: Observational

  • Group non-C

    Patients with no perioperative complications

    Other: Observational

Interventions

  • OtherObservational

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 24 hours

  2. New developments in the perioperative period respiratuary complications

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

    Time frame: Up to 24 hours

Secondary outcomes

  1. Time of hospital

    Time in hospital after surgery

    Time frame: 2 weeks

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Study locations

1 site
  • Samsun University
    Samsun, Canik 55090, Turkey
08

References and documents

Publications

  • 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. PubMed 25926315 ↗
  • 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. PubMed 32711836 ↗
  • 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. Erratum In: J Gen Intern Med. 2016 Apr;31(4):450. doi: 10.1007/s11606-015-3420-5. PubMed 25373832 ↗
  • 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. PubMed 36972037 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06203171
Lead sponsor
Samsun University
Responsible party
Sponsor
First posted
Jan 12, 2024
Start date
Oct 15, 2023
Primary completion
Apr 1, 2024
Completion
Apr 1, 2024
Last update
Apr 19, 2024

Study contacts

OZGUR KOMURCU, 1
principal investigator · Samsun University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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