About this trial
Through a multicenter, three-arm randomized controlled trial design, this study aimed to compare the effects of three positioning strategies-side-lying with elevated head position, supine with elevated head position, and standard side-lying position-on the incidence of hypoxemia during the recovery phase in patients undergoing painless gastroscopy and colonoscopy. The goal was to provide clinicians with a simple, non-invasive, and cost-effective optimization strategy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Severe cardiovascular or cerebrovascular diseases.
Pregnant patients.
History of hypersensitivity to ciprofol.
Endotracheal intubation required during the procedure.
Trial design
Parallel
Treatments tested in this trial
lateral decubitus head-up position (LH group)
Procedure/SurgeryAn angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position. Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response. Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score. Prior to enrollment, all patients remain in the left lateral position (bed head elevated 0°, consistent with the examination position). Patients assigned to the lateral supine head-elevated group (LH group) maintain their pre-assigned lateral position with the head elevated 30°.
supine head-up position (SH group)
Procedure/SurgeryAn angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position. Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to tactile or pain stimuli; 5 = asleep but slow to tactile or pain responses; 6 = deep sleep with no response. Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score. All patients are initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination). Patients assigned to the supine head-elevated group (SH group) are transitioned from the lateral position to supine without a headrest, with the head elevated at 30°.
standard lateral decubitus position group (SL group)
Procedure/SurgeryAn angle measuring device was placed beside the head of the examination bed to facilitate precise adjustment of the head position. Upon admission to the recovery room, the patient's Ramsay Sedation Scale was assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response. Patients scoring 2-4 were immediately randomized into the study group, while those below this range were randomized after achieving the required score. All patients were initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination). Patients in the Standard Lateral Position Group (SL group) maintained their original left lateral position with the head elevated at 0°.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of recovery-phase hypoxemia
Proportion of participants experiencing hypoxemia (SpO₂ ≤ 90% lasting \>10 seconds) during the post-procedure recovery period
Secondary outcomes
Incidence of Subclinical Respiratory Depression during Recovery
Proportion of participants experiencing subclinical respiratory depression, defined as any episode of pulse oxygen saturation (SpO₂) in the range of 90% to \<95% (inclusive of 90%, exclusive of 95%) during the post-procedure recovery period
Overall Incidence of Airway Intervention During Recovery
Proportion of participants requiring any grade of airway intervention (increase oxygen flow, chin lift, mask ventilation, or reintubation) during recovery.
Cough Severity Grade During Recovery
Severity of cough assessed during the recovery period, graded as: Grade I: No cough, smooth breathing; Grade II: Single mild cough; Grade III: Multiple coughs lasting \<15 seconds; Grade IV: Continuous coughing lasting ≥15 seconds. Reported as the proportion of participants reaching each grade (I-IV).
Length of Stay in Post-Anesthesia Care Unit (PACU)
Time from admission to the post-anesthesia care unit (PACU) until discharge criteria are met (modified Aldrete score ≥9 on three consecutive assessments), recorded in minutes.
Sponsors and contacts
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General Hospital of Ningxia Medical University
Lead sponsor
Yinchuan Traditional Chinese Medicine Hospital
Collaborator
Guyuan Municipal People's Hospital
Collaborator
Wuzhong City People's Hospital
Collaborator
Zhongwei City People's Hospital
Collaborator
Shizuishan City People's Hospital
Collaborator
Zhongwei City Traditional Chinese Medicine Hospital
Collaborator
Pingluo County People's Hospital
Collaborator
Tongxin County People's Hospital
Collaborator
Yanchi County People's Hospital
Collaborator
Zhongning County People's Hospital
Collaborator
Lingwu City People's Hospital
Collaborator
Qingtongxia City People's Hospital
Collaborator