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RECRUITING
NCT07903545
NA

Recovery Time With the Application of ALDRETE Score in Patients Undergoing Gastrointestinal Endoscopy

Sponsor: Konstantopoulio-Patission General Hospital of Nea Ionia

View on ClinicalTrials.gov

Summary

Over the past decades, the volume and complexity of gastrointestinal endoscopy (GI) interventions have increased due to the progress in diagnostic and therapeutic procedures along worldwide implementation of colorectal cancer screening and surveillance programs. Nowadays, the first line for procedural sedation is either propofol or midazolam, in combination with opiates when analgesia is required, depending on the country's human resources, service framework, and legislation. Provision of sedation has been shown to decrease patient's anxiety, discomfort and pain improving at the same time procedure efficiency. However, administration of sedative and/or analgesic medications is not risk-free, as a variety of serious adverse effects i.e. respiratory depression, arrhythmia or hypotension may occur. In this regard, optimal discharge management after a procedure with sedation/analgesia, until the patient returns to a fully conscious, clinically stable, and ideally cognitively functional state can be challenging for both endoscopists and nursing personnel\[6\]. In an effort to address this, international endoscopy societies suggest the use of standardized discharge criteria and scoring systems such as the Post Anesthesia Recovery (PAR), or Aldrete, score, Aldrete scoring system and the modified post-anesthesia discharge scoring system (mPADSS), combined with clinical assessment to ensure patient safe discharge and readiness for discharge. Still, data supporting the use of Aldrete score derive mainly from studies evaluating patients discharge post-surgery, while evidence for model use in the setting of GI endoscopic procedures remain scant\[8,9\]. In this context, the investigators conducted a randomized controlled trial (RCT) aiming to explore the impact of Aldrete scoring system on safe discharge of participants who have undergone GI procedures under analgesia/sedation.

Official title: Recovery Time With the Application of ALDRETE Score in Patients Undergoing Gastrointestinal Endoscopy: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1300

Start Date

2026-08-18

Completion Date

2027-08-18

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

PROCEDURE

The post-anesthesia recovery or Aldrete score has been commonly used to clinically assess the physical status of patients recovering from the anesthetic experience and to follow their awakening proces

Patients randomized to the intervention arm upon arrival in the recovery area were assessed by endoscopy nurses experienced in Aldrete score implementation when discharging patients. The Aldrete score was calculated every 10 minutes using a structured questionnaire (Supplementary File B) and after a minimum of 10 minutes, patients could be discharged from the recovery area if their Aldrete score was ≥9, with their accompanying person. Patients assigned to the standard of care Group (SOC) were assessed in the recovery area by other endoscopy nurses in a subjective empirical manner. After a minimum of 10 minutes first, patients' vital signs and consciousness were assessed and if deemed within normal range the patient could be discharged also accompanied by the responsible person. In case the endoscopy nurse considered those requirements inadequate the patient remained in the recovery area and was re-evaluated 5 min later again assessing the same parameters. This process with 5 min interv

Locations (1)

Konstantopoulio - Patision" General Hospital, Athens, Greece

Athens, Greece