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Completed

NCT Number: NCT05842720

Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure

This study aim to examine the safety and feasibility of unsedated colonoscopy in patients with high risk for sedation (ASA score≥3).

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba medical center Tel Hashomer

Ramat Gan, 5262000, Israel

About this study

This was a two-part study: Part 1 was a retrospective study of patients with ASA score≥3 that underwent unsedated colonoscopy from May 2021 to August 2022 at Sheba medical center, who were contacted up to one year after the procedure and were asked to assess their satisfaction and pain level on a standard Likert score from 1-5. Part 2 was a prospective study which included high risk patients who were scheduled for an anesthesiologist-assisted sedated-colonoscopy and who consented to undergo an unsedated procedure. The primary outcome was patients' satisfaction during and up to one week after the procedure. Pain level, adverse events and hemodynamic parameters during the procedure were secondary outcomes. Baseline State-Trait Anxiety Inventory (STAI) questionnaire were also administered and results examined vis-à-vis satisfaction scores

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Only adults (>18 years of age) that will be assessed as high risk and require an anesthesiologist clinic assessment prior to the procedure and anesthesiologist presence during the procedure.

Exclusion criteria

  • Patients that are planned to go through both gastroscopy and colonoscopy procedures.
  • Patients with known adhesions and/or prior small bowel obstructions.
  • Patients that are planned to have a complicated procedure (complicated polypectomy etc).
  • Patients that are not able to give their consent with a full understanding of the procedure.
  • Patients that are pregnant.
  • Patients with a heart rate above 120 bpm or less than 40 bpm at the baseline as measured before starting the procedure.
  • Patients with a systolic blood pressure above 180mmHg or bellow 90mmHg as measured at the baseline before starting the procedure.

Treatment and study plan

un-sedated colonoscopies

Procedure

un-sedated colonoscopies in high risk patients with ASA>=3

Primary outcomes

  1. satisfaction rate

    Time frame: up to 1 week after the date of the procedure

    Overall satisfaction score as assessed by Likert scale post-procedure

Secondary outcomes

  1. Recovery time after the procedure

    Time frame: up to 24 hours after the procedure

    the time lapse between extraction of colonoscope from the rectum and discharge of the patient from the Endoscopy recovery unit.

  2. Complications or adverse effects rates during the procedure

    Time frame: from the beginning of the procedure until the end of the procedure

    perforations, post-polypectomy bleeding, bradycardia (defined as pulse rate under 40 bpm), low oxygen saturation (defined as saturation below 90% under nasal oxygen cannula) or hemodynamically instability (defined as systolic blood pressure below 90mmHg and diastolic blood pressure below 60mmHg)

  3. Complete examination rates

    Time frame: from the beginning of the procedure until the end of the procedure

    how many examination were completed up to cecum intubation without need for sedation

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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