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Comparative study for different ventilation modes in the elderly patients with ERCP under monitored anaesthesia

Comparative study for different ventilation modes in the elderly patients with ERCP under monitored anaesthesia: study protocol for a single-center, randomized, controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025182
Enrollment
Unknown
Registered
2019-08-15
Start date
2019-08-15
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

ERCP?????????

Interventions

Nasopharyngeal airway group:Nasopharyngeal airway
Endoscopic mask group:Endoscopic mask

Sponsors

General Hospital of Northern Theater Command of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 70years; 2. ASA:II or III; 3. Volunteer to participate in this experiment, can cooperate with the completion of the entire experimental process.

Exclusion criteria

Exclusion criteria: 1. Blood coagulation dysfunction (such as PT or INR >=1.5 x ULN, APTT >= 1.5 x ULN, preoperative hemophilia without supplementation of coagulation factors, abnormal hemostasis caused by abnormal platelets) or nosebleeding or nasal polyps; 2. Respiratory and circulatory diseases that are not properly controlled and may be life-threatening, such as uncontrolled severe hypertension, severe arrhythmias, unstable angina pectoris, hemorrhagic shock, resting ECG heart rate =80x10^9/ L), gastrointestinal obstruction with gastric content retention; 4. Allergic to propofol, eggs, soybeans or albumin, etc; 5. Renal dysfunction,urea or urea nitrogen>=1.5xULN,serum creatinine>=1.0xULN; 6. Diabetics whose blood glucose was not controlled satisfactorily (blood glucose>=11.1mmol/L during screening period); 7. Suffer from mental illness (such as schizophrenia, mania, insanity, etc); 8. Hypertension with uncontrolled blood pressure (systolic blood pressure>=180mHg during screening period, and / or diastolic blood pressure>=100 mmHg during screening period); 9. The basal oxygen saturation (SpO2) was less than 95%.

Design outcomes

Primary

MeasureTime frame
SpO2;

Secondary

MeasureTime frame
Incidence of body movement, cough, nausea, vomiting, pain, dizziness, delirium and sore throat between entering the operating room and leaving the recovery room;Incidence of respiratory depression (RR < 8 times / min);The number of cases of mandibular lift and the number of cases of mask ventilation;Blood gas analysis (PaCO2 mmHg, PaO2 mmHg, PH, BEmmol/L, HCO3-mmol/L);Anesthesiologist, endoscopic doctor, patient satisfaction;Dosage of sufentanil, propofol, dextromethomide;Anaesthesia recovery time (time between withdrawal of medication and normal response of the patient), operation time;

Countries

China

Contacts

Public ContactSong Dandan

General Hospital of Northern Theater Command of the Chinese People's Liberation Army

songdandan6@163.com+86 13352455132

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026