NCT07032012: iPAEonAnx

Impact of Pre-anesthetic Evaluation on the Anxiety

Not yet recruiting NA Last updated 22 June 2025

What this trial tests

NA trial testing control - anxiety evaluation before Pre-anesthetic in Anxiety in 100 participants. Not yet recruiting.

Timeline

1 July 2025

Primary endpoint
30 September 2025

30 September 2025

Quick facts

Lead sponsor	Hospital de Base
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	100
Start date	1 July 2025
Primary completion	30 September 2025
Estimated completion	30 September 2025

Drugs / interventions tested

• control - anxiety evaluation before Pre-anesthetic
• group intervention - anxiety evaluation after Pre-anesthetic

Conditions studied

• Anxiety — all drugs for Anxiety →
• Postoperative Care — all drugs for Postoperative Care →
• Preoperative Anxiety — all drugs for Preoperative Anxiety →

Sponsor

Hospital de Base

Who can join

Adults 18 to 65, any sex, with Anxiety or Postoperative Care. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Since the last century, it has been understood that "the pre-anesthetic evaluation is the patient's right and the anesthesiologist's duty." As early as 2006, the Conselho Federal de Medicina (CFM) published a resolution addressing the anesthetic act and guiding the conduct of pre-anesthetic evaluation (PAE) and in 2017 revised these guidelines in a new resolution. The PAE is an important step in preparing the patient for elective surgical procedures. It refers to the moment when the anesthesiologist and patient have the opportunity to get to know each other, optimize the patient's clinical conditions and even request exams or consult other specialists when necessary. The prevalence and levels of anxiety, commonly generated by the expectation of the surgical-anesthetic procedure, tend to reduce with the PAE. This leads to fewer patients presenting to the operating room with arterial hypertension or arrhythmia, which are triggered by anxiety. It can be said that the implementation of the PAE directs screening processes and consequently reduces the patient's risk to unnecessary procedures or consultations. It also highlights the reduction in perioperative morbidity and mortality rates. By analyzing the dynamics of the surgical center, where the space is highly technological and contested by various surgical specialties, it is possible to associate the PAE with the reduction in cancellation rates of procedures and the proper use of space. Measuring sentiment is difficult and to assess anxiety, one can use complex questionnaires to small and objective scales. Some studies show how anxiety can contribute to increased postoperative pain, higher medication consumption, and longer hospitalization time. A possible tool to change this scenario would be the PAE, but its relationship with anxiety still needs to be further documented, especially in Brazil. Therefore, this project seeks to study the hypothesis that the PAE reduces anxiety levels, brings quality to the anesthetic-surgical experience, and improves perioperative morbidity indicators. This study aims to evaluate the impact of pre-anesthetic evaluation on perioperative surgical outcomes in patients of the orthopedic specialty undergoing procedures at the institution. It aims to identify the anxiety level of patients undergoing orthopedic surgery. This randomized clinical trial will be conducted at the Hospital de Base do Distrito Federal, Brasília, Distrito Federal, Brazil.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.