None
Conditions
Interventions
Lidocaine group:Administer intravenous 2% lidocaine at a dose of 1.5 mg/kg as a slow bolus over 1–2 minutes, given 1–2 minutes before sedation induction. Subsequently, continue a continuous infusion o
Normal saline group:Administer intravenous 0.9% normal saline of the same volume as the lidocaine regimen (1.5 mg/kg equivalent volume) as a slow bolus over 1–2 minutes, given 1–2 minutes before sedat
Sponsors
Yunnan Diqing Tibetan Autonomous Prefecture Tibetan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–70 years; 2. American Society of Anesthesiologists (ASA) physical status I–III; 3. Body mass index (BMI) 18–30 kg/m^2; 4. Planned to undergo simultaneous painless gastroscopy and colonoscopy at the institutional endoscopy center; 5. Residing at an altitude of >=2500m for >=1 year (highland-adapted population, including local Tibetans and long-term resident Han Chinese); 6. Resting oxygen saturation (SpO2) >=90% on room air without significant dyspnea; 7. Able to understand the study content and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of allergy to propofol, soy/egg products, lidocaine, or other amide-type local anesthetics. 2. Known second- or third-degree atrioventricular block, severe arrhythmias, significant sinus bradycardia (heart rate 2 times the upper limit of normal, or eGFR =5 with significant daytime sleepiness). 8. Use of class I antiarrhythmic drugs, continuous intravenous local anesthetics, or other medications that significantly affect lidocaine metabolism within the past week. 9. Pregnancy or breastfeeding. 10. Presence of significant psychiatric or cognitive impairment that precludes cooperation with scoring or follow-up. 11. Planned complex therapeutic endoscopic procedures (e.g., large polyp resection, extensive mucosal resection) with an expected procedure time >60 minutes. 12. Any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total propofol consumption (mg) during the entire painless gastroscopy and colonoscopy procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of oxygen desaturation events (SpO2 10 s);Frequency of interventions related to hypoxemia (increase in oxygen flow rate, jaw thrust, positive pressure ventilation, etc.);Incidence of hypotension (MAP = 20% from baseline);Incidence of bradycardia (HR = 30% from baseline) and other cardiac arrhythmias;Proportion requiring intervention with vasoactive agents or atropine;Incidence of intraoperative body movement, struggling, and cough reflex;Endoscopist’s sedation satisfaction score (0–10 points);Recovery time (from termination of drug administration to eye opening with response);Time to discharge from recovery room;Scores of pharyngeal discomfort, abdominal pain, nausea, and vomiting at 30–60 min postoperatively;Fatigue and overall comfort at 24 h postoperatively;Patient overall satisfaction (0–10 scale);Patient’s memory of the procedure;Incidence of lidocaine-related neurological and cardiovascular adverse reactions;Serious adverse events (including requirement for tracheal intubation, cardiopulmonary resuscitation, ICU admission, etc.); | — |
Countries
China
Contacts
Public ContactWen Yun
Yunnan Diqing Tibetan Autonomous Prefecture Tibetan Hospital
Outcome results
None listed