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Safety and efficacy evaluation of an anesthesia guidance protocol based on heart-rate (HR) and perfusion-index (PI) variability in patients undergoing painless gastrointestinal endoscopy

Safety and efficacy evaluation of an anesthesia guidance protocol based on heart-rate (HR) and perfusion-index (PI) variability in patients undergoing painless gastrointestinal endoscopy - HR-PI-Guided Anesthesia for Painless GI Endoscopy: Safety and Efficacy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126141
Enrollment
Unknown
Registered
2026-06-04
Start date
2026-06-08
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastrointestinal diseases

Interventions

Observation group:None
Conventonal group:The anesthesiologist determines the timing for endoscope insertion based on clinical experience (1–3 minutes after induction, indicated by the loss of eyelash reflex).
Pulse Perfusion Index(PI) Steering group:Perform gastroscopy after the PI reaches its peak value

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–75 years, with ASA physical status classification Grade ?–?. 2. Scheduled for painless gastroenteroscopy. 3. Having signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe cardiovascular diseases: uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg), coronary heart disease (history of myocardial infarction within the past 6 months), cardiac arrhythmias (atrial fibrillation/ventricular tachycardia). 2. Peripheral circulatory disorders: Raynaud’s syndrome, acral vascular lesions (e.g., diabetic foot). 3. Respiratory system diseases: acute exacerbation of chronic obstructive pulmonary disease (COPD), status asthmaticus. 4. Hepatic or renal insufficiency: Child-Pugh class B or higher, serum creatinine > 133 µmol/L. 5. Hypersensitivity to ciprofol or sufentanil. 6. Pregnant or lactating women. 7. Mental illness or cognitive impairment, unable to cooperate with monitoring. 8. Refusal to participate in the study or inability to complete follow-up.

Design outcomes

Primary

MeasureTime frame
Pulse Perfusion Index;Heart Rate;Primary endoscope insertion success rate;C-statistic;—

Secondary

MeasureTime frame
Blood oxygen saturation;Blood pressure;Ciprofol usage amount;Recovery time;Length of stay in the PACU;The incidence of PONV within 24 hours;Model calibration;The incidence of hypotension;The incidence of bradycardia;Duration of hypotension;—

Countries

China

Contacts

Public ContactWei Zhao

Zhujiang Hospital, Southern Medical University

zw618812@smu.edu.cn+86 155 2111 8430

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026