painless electronic colonoscopy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Patients must meet all the following criteria to be included in this study: 1. Age between 18 and 65 years, regardless of gender; 2. Patients undergoing painless colonoscopy; 3. ASA (American Society of Anesthesiologists) score of I or II; 4. 18 kg/m²<BMI<28 kg/m²; 5. Fully understanding and voluntarily participating in the study, with informed consent signed by the patient themselves.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Patients with any of the following conditions will not be included in this study: 1. Planned endotracheal intubation (including laryngeal mask) patients; 2. Patients requiring complex endoscopic diagnostic and treatment techniques; 3. History of intestinal stenosis or adhesion; 4. Acute heart failure; unstable angina; myocardial infarction within the past 6 months; 5. Patients with severe respiratory diseases; 6. Patients with psychiatric disorders, long-term use of psychiatric drugs, and cognitive impairment; 7. Patients judged to have difficult airway management (Mallampati score of IV); 8. Patients with severe impairment of major organ functions such as liver and kidney; 9. History of drug abuse, drug addiction, or alcohol abuse within 2 years before screening, where alcohol abuse is defined as daily average alcohol consumption exceeding 2 units (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine); 10. Patients not receiving regular antihypertensive treatment or with poor blood pressure control (sitting systolic blood pressure =160 mmHg or =90mmHg, and/or diastolic blood pressure =100mmHg during screening); 11. Use of benzodiazepines and/or opioids daily within the last month or intermittently in the last three months; 12. Allergy or contraindications to opioids, propofol, or their components; 13. Pregnant or breastfeeding women; 14. Patients with a plan to conceive within 3 months (including males); 15. Participation in any clinical trial within the last 3 months; 16. Patients deemed unsuitable for this trial by the researchers. Withdrawal Criteria: Trial participation will be terminated if a subject meets one or more of the following criteria: 1. Voluntary withdrawal of informed consent at any time by the participant; 2. Ineligibility discovered after randomization; 3. Any clinical adverse event, abnormal laboratory test, or other medical condition occurs that could result in no further benefit from the trial medication; 4. Total duration of colonoscopy >30 minutes; 5. Other reasons deemed by the researcher to discontinue trial treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total dosage of propofol; | — |
Secondary
| Measure | Time frame |
|---|---|
| additional dose of propofol;the times of additional propofol;dose of propofol(mg/kg);the incidence of hypoxaemia;the incidence of hypoxaemia;improved amsterdam Preoperative Anxiety and Information Scale(APAIS);the success rate of sedation;anesthesia induction time;bispectral index(BIS);modified observer‘s assessment of alertness/sedation;time of full consciousnesss;standard time of dicharge;the insertion time of colonscopy;total time of colonoscopy examination;visual analogue scale(VAS)pain after examination;clinician satisfaction with sedation instrument(CSSI);satisfaction of colonoscopy physicians;patient satisfaction with sedation instrument(PSSI);review intention evaluation;the incidence of adverse events during the experiment;adverse reaction rate within 24 hours after examination;evaluation of patient acupuncture acceptance; | — |
Countries
China
Contacts
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine