NCT07545642

Brief Summary

Using prospective real-world data, this study aims to determine whether the lateral decubitus position reduces the incidence of post-procedure hypoxemia in patients undergoing painless gastroscopy/colonoscopy, thereby providing a simple, non-invasive, and low-cost optimization strategy for clinical practice.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
960

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

April 7, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 7, 2026

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of recovery-phase hypoxemia,

    Proportion of participants experiencing hypoxemia (SpO₂ ≤ 90% lasting \>10 seconds) during the post-procedure recovery period.

    From PACU admission until discharge, assessed up to 30 minutes

Secondary Outcomes (12)

  • Incidence of Subclinical Respiratory Depression during Recovery

    From PACU admission until discharge, assessed up to 30 minutes.

  • Incidence of Severe Hypoxemia During Recovery

    From PACU admission until discharge, assessed up to 30 minutes

  • Overall Incidence of Airway Intervention During Recovery

    From PACU admission until discharge, assessed up to 30 minutes

  • Cough Severity Grade During Recovery

    From PACU admission until discharge, assessed up to 30 minutes

  • Length of Stay in Post-Anesthesia Care Unit (PACU)

    From PACU admission until discharge

  • +7 more secondary outcomes

Other Outcomes (1)

  • Prespecified Subgroup Analyses

    From PACU admission until discharge, assessed up to 30 minutes

Study Arms (2)

Supine position group (Group S)

EXPERIMENTAL

The patient was turned from the predetermined left lateral position to the supine position without a head pillow (head-of-bed elevation at 0 degrees)

Procedure: Supine position group (Group S)

Lateral decubitus position group (Group L)

EXPERIMENTAL

Upon arrival in the post-anesthesia care unit (PACU), the patient was kept in the left lateral decubitus position

Procedure: Lateral decubitus position group (Group L)

Interventions

Upon admission to the Post-Anesthesia Care Unit (PACU), an independent researcher (attending anesthesiologist) assessed the patient using the Ramsay Sedation Scale (1: anxious and agitated; 2: awake, calm, and cooperative; 3: drowsy but responsive to verbal commands; 4: asleep but responsive to tactile stimulation or pain; 5: asleep with a sluggish response to stimulation; 6: deep sleep with no response). Patients in the Lateral Group (Group L) were maintained in the predetermined left lateral position. Standard monitoring was applied, and nasal cannula oxygen was administered at 2 L/min. If SpO₂ remained \>95% for at least 5 minutes, oxygen was discontinued for observation. To ensure strict adherence to the protocol, an independent researcher continuously monitored and verified patient positioning (corrections were made only if the patient rolled unconsciously). Patients were evaluated using the Aldrete discharge scoring system; discharge from the PACU occurred when a score of \>9 was a

Lateral decubitus position group (Group L)

Upon admission to the Post-Anesthesia Care Unit (PACU), an independent researcher (attending anesthesiologist) assessed the patient using the Ramsay Sedation Scale (1: anxious and agitated; 2: awake, calm, and cooperative; 3: drowsy but responsive to verbal commands; 4: asleep but responsive to tactile stimulation or pain; 5: asleep with a sluggish response to stimulation; 6: deep sleep with no response). Patients in the Supine Group (Group S) were turned from the predetermined lateral position to the supine position without a head pillow (head-of-bed elevation at 0 degrees). Standard monitoring was applied, and nasal cannula oxygen was administered at 2 L/min. If SpO₂ remained \>95% for at least 5 minutes, oxygen was discontinued for observation. To ensure strict adherence to the protocol, an independent researcher continuously monitored and verified patient positioning (corrections were made only if the patient rolled unconsciously). Patients were evaluated using the Aldrete discharge

Supine position group (Group S)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status classification I-III.
  • Scheduled for combined painless esophagogastroduodenoscopy/colonoscopy or either of the two procedures.
  • Ability to understand the study protocol and provide written informed consent.

You may not qualify if:

  • Severe cardiovascular or cerebrovascular diseases.
  • Pregnant patients.
  • History of hypersensitivity to ciprofol.
  • Withdrawal Criteria:
  • Endotracheal intubation required during the procedure.
  • Voluntary withdrawal requested by the patient or their legal representative.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General hospital of Ningxia medical university, Yinchuan, Ningxia

Yinchuan, Ningxia, 750001, China

RECRUITING

Study Officials

  • Xinli Ni, Doctoral

    86-951-674-3252

    STUDY CHAIR

Central Study Contacts

Xiaoyong Wei, Degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Random sequence generation was performed by an independent statistician using computer-generated codes. Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes (SNOSE), which were opened immediately prior to intervention implementation. Due to the nature of the intervention (body positioning), blinding of participants and personnel was not feasible; however, outcome assessors were blinded, and objective outcome measures were utilized to minimize detection bias."
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 22, 2026

Study Start

April 23, 2026

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations