Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06203171
Other study ID # SUKAEK-2023 17/16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 15, 2023
Est. completion date April 1, 2024

Study information

Verified date April 2024
Source Samsun University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Elective surgery - ASA = 3 patients - Patients over 18 years of age Exclusion Criteria: - Emergency surgeries - ASA > 3 patients - Pregnant women - Age > 80 - Age < 18

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational
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.

Locations

Country Name City State
Turkey Samsun University Samsun Canik

Sponsors (1)

Lead Sponsor Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Perioperative hemodynamic complications New developments in the perioperative period hemodynamic complications
Hypertension; systolic arterial pressure >160 mm Hg
Hypotension; mean arterial pressure < 65 mmHg
Cardiac arrhythmia
Acute Coronary syndrome; ECG changes and/or cardiac enzyme elevation accompanied by chest pain
Up to 24 hours
Primary New developments in the perioperative period respiratuary complications Respiratory Failure; Oxygen saturation < 90 or tachypnea (respiratory rate > 20/min Up to 24 hours
Secondary Time of hospital Time in hospital after surgery 2 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04602429 - Children's Acute Surgical Abdomen Programme
Completed NCT04167410 - Effect of Perioperative Glycemia Protocol on Glycemic Outcomes in Diabetic Patients Undergoing Abdominal Surgery N/A
Terminated NCT04506372 - Management of Angiotensin Inhibitors During the Perioperative Period N/A
Completed NCT04006106 - Defining ENDOtypes in Perioperative Hypersensitivity by Extensive Cellular and Molecular PHENotyping (ENDOPHEN)
Not yet recruiting NCT06065137 - Standardised Drug Provocation Testing in Perioperative Hypersensitivity Phase 4
Completed NCT04120324 - Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty
Not yet recruiting NCT06279000 - Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery Phase 3
Completed NCT02958293 - Perioperative Morbidity in Elective Surgery Based on the Time of the Year
Recruiting NCT04120012 - The Effect of Frailty to Perioperative Complications in the Elderly
Completed NCT04665349 - Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments N/A
Recruiting NCT04266574 - BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study N/A
Recruiting NCT04256798 - Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery Phase 3
Completed NCT04260334 - Preoperative Care In Ovarian Cancer Patients N/A
Recruiting NCT05533112 - Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia N/A
Completed NCT06097052 - Hypotension Predictive Index Effect on Intraoperative Hypotension During Pancreatic Surgery.
Recruiting NCT06035627 - The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.
Not yet recruiting NCT06326528 - SGLT2 Inhibitors and Perioperative Period
Recruiting NCT04347772 - Effectiveness of Intensive Perioperative Nutrition Therapy Among Adults Undergoing Gastrointestinal & Oncology Surgery N/A
Completed NCT03974321 - Intraoperative Hypotension and Perioperative Myocardial Injury
Completed NCT04573738 - Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer N/A