ClinicalTrials.gg
RecruitingNCT07903545Updated Oct 29, 2026

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

An interventional study of 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 in Patients Undergoing Gastrointestinal Endoscopy, sponsored by Konstantopoulio-Patission General Hospital of Nea Ionia. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Konstantopoulio-Patission General Hospital of Nea Ionia · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patients Undergoing Gastrointestinal Endoscopy

Keywords

  • sedation
  • aldrete score
  • recovery
03

In context

Lead sponsor

Konstantopoulio-Patission General Hospital of Nea Ionia is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing gastroscopy and/or colonoscopy
  • Age ≥ 18 years
  • Ability to understand instructions in Greek language
  • Ability to provide written

Exclusion criteria

Exclusion Criteria:

  • Patients scheduled to undergo sigmoidoscopy
  • Unable to provide were excluded
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,300 participants (estimated)

Study arms

  • No intervention
    Comparator

    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

  • Active comparator
    Patients assessment of patients in resuscitation room using the modified ALDRETE score and exit when

    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.

    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

Interventions

  • ProcedureThe 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

06

What researchers measure

Primary outcomes

  1. Recovery time

    Patients randomized to the intervention arm upon arrival in the recovery 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 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.

    Time frame: From enrollment through study completion, an average of 1 year

Secondary outcomes

  1. Adverse events rate

    Time frame: Until the end of the study

07

Study locations

1 of 1 sites recruiting
  • Konstantopoulio - Patision" General Hospital, Athens, Greece
    Athens, 151 27, Greece
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07903545
Lead sponsor
Konstantopoulio-Patission General Hospital of Nea Ionia
Responsible party
Tziatzios Georgios (Consultant Gastroenterology Department MD, PhD, Konstantopoulio-Patission General Hospital of Nea Ionia) — Principal investigator
First posted
Oct 29, 2026
Start date
Aug 18, 2026
Primary completion
Apr 18, 2027 (estimated)
Completion
Aug 18, 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Georgios Tziatzios, Phd
Contact
g_tziatzios@yahoo.gr
00306942259009

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion