A study of complication incidence in high-risk patients (ASA class III) undergoing esophagogastroduodenoscopy with colonoscopy under total intravenous anesthesia: A prospective study

Active, not recruiting

• Conditions: patients with ASA class III undergoing upper GI endoscopy and colonoscopy under iv anesthesia; complication incidence , Total Intravenous Anesthesia

• Registration Number: TCTR20240412005
• Lead Sponsor: Department of Anesthesiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-12
• Last Update Posted: 19 August 2024
• Study Completion: 2025-04-02

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 403

Inclusion Criteria

1. Patients for Upper Gastrointestinal Endoscopy and colonoscopy:
1.1 Individuals undergoing upper gastrointestinal endoscopy and colonoscopy.
1.2 Administration of intravenous anesthesia restricted to business hours.
1.3 ASA Class III classification.
1.4 Inpatient and outpatient (one-day surgery) participants.
1.5 No gender restrictions.
1.6 Elective procedure.
2. Age Requirement
2.1 Participants aged 18 years and above.
3. ASA Class III Criteria:
3.1 ASA Class III classification, excluding those in critical condition.
3.2 Stable respiratory and circulatory systems.
4. Non-Emergency Procedure:
4.1 Patients not presenting for emergency gastrointestinal endoscopy and colonoscopy.

Exclusion Criteria

1.Critical Condition or Sepsis:
1.1 Patients in critical condition or with sepsis.
2. Communication Problems:
2.1 Patients with communication difficulties.
3. Substance Use History:
3.1 Patients with a history of substance misuse or inappropriate drug use.
4. Pregnancy:
4.1 Pregnant patients.
5. Difficult Airway Management Suspicions:
5.1 Patients suspected of having difficulties in airway management.
6. Emergency Gastrointestinal Endoscopy:
6.1 Patients coming for emergency gastrointestinal endoscopy.
7. Refusal to Participate:
7.1 Patients unwilling to participate in the research.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication Incidence at 12 months after Complication Incidence at intraoperation and post-operation

Secondary Outcome Measures

Name	Time	Method
To assess patient satisfaction scores regarding the care provided during intravenous anesthesia, aiming to gather insights into the patient experience and improve the quality of care. at 12 month after By questionnaire