Patients Undergoing Gastrointestinal EndoscopyNCT07903545
Recovery Time With the Application of ALDRETE Score in Patients Undergoing Gastrointestinal Endoscopy
A study testing 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 people with Patients Undergoing Gastrointestinal Endoscopy, run by Konstantopoulio-Patission General Hospital of Nea Ionia at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Gastrointestinal Endoscopy
- What is being tested?
- 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteGreece
- Study dates
- 18 Aug 2026to 18 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing gastroscopy and/or colonoscopy
- Age ≥ 18 years
- Ability to understand instructions in Greek language
- Ability to provide written informed consent
Who cannot join
- Patients scheduled to undergo sigmoidoscopy
- Unable to provide informed consent were excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Konstantopoulio - Patision" General Hospital, Athens, Greece
Athens, 151 27
Georgios Tziatzios, phd, 00306942259009, g_tziatzios@yahoo.gr
About this study
Official title: Recovery Time With the Application of ALDRETE Score in Patients Undergoing Gastrointestinal Endoscopy: a Randomized Controlled Trial
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.
- Being tested
- 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
- Keywords
- sedation, aldrete score, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 procesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Comparator | No intervention | 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 |
| Patients assessment of patients in resuscitation room using the modified ALDRETE score and exit when | Active comparator | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through study completion, an average of 1 year
Secondary outcomes (1)
Adverse events rate
Measured: Until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start18 Aug 2026
- Primary completion18 Apr 2027 (estimated)
- Study completion18 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konstantopoulio-Patission General Hospital of Nea Ionia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tziatzios Georgios, Konstantopoulio-Patission General Hospital of Nea Ionia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903545
- Sponsor's protocol ID
- EBΔ 9864/4-4-22
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Time With the Application of ALDRETE Score in Patients Undergoing Gastrointestinal Endoscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07903545
- Acronym / sponsor ID
- EBΔ 9864/4-4-22
- Keywords
- sedation, aldrete score, recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Konstantopoulio-Patission General Hospital of Nea IoniaUniversity, hospital or other
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- 18 Apr 2027 (estimated)
- Study completion
- 18 Aug 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | No intervention | –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 |
| Patients assessment of patients in resuscitation room using the modified ALDRETE score and exit when | Active comparator | 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 procesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing gastroscopy and/or colonoscopy
- Age ≥ 18 years
- Ability to understand instructions in Greek language
- Ability to provide written informed consent
Key exclusion criteria (2 listed)
- Patients scheduled to undergo sigmoidoscopy
- Unable to provide informed consent were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 procesPatients 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 | Procedure or surgery | Patients assessment of patients in resuscitation room using the modified ALDRETE score and exit when |
Primary outcome
Recovery time
Time frame: From enrollment through study completion, an average of 1 year
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.
1 secondary outcome
Adverse events rate
Time frame: Until the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Patients Undergoing Gastrointestinal Endoscopy, run by Konstantopoulio-Patission General Hospital of Nea Ionia at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgios Tziatzios, Phd (00306942259009, g_tziatzios@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time (time frame: From enrollment through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.