Comparison of dexmedetomidine-propofol and sufentanil-propofol administration during sedation-guided gastrointestinal endoscopy

Comparison of the efficacy and safety of dexmedetomidine combined with propofol and sufentanil combined with propofol in sedation for gastrointestinal endoscopy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200057956

Enrollment

Unknown

Registered

2022-03-24

Start date

2022-03-25

Completion date

Unknown

Last updated

2025-01-13

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

Conditions

None listed

Interventions

Group 1:Dexmedetomidine

Group 2:Sufentanil

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The age ranged from 18 to 65 years; 2. Patients who underwent gastroscopy and colonoscopy under anesthesia; 3. ASA is classified as Grade I to II; 4. 18.0 <= body mass index (BMI) <= 30; 5. Mallampati classified as Grade I to II; 6. Fully understand the purpose and significance of this trial, voluntarily participate in this clinical trial, be able to read and understand the informed consent form, and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Inability to ambulate without assistance; 3. Patients with bradycardia (heart rate <= 60 beats /min) severe arrhythmia history or cardiac insufficiency history; 4. Clinical diagnosis of cognitive impairment in medical history; 5. Body weight greater than 100 kg; 6. Allergies to soybeans, glycerol or medications used in this study; 7. Previous diagnosis of acute or chronic renal impairment; 8. Severe liver damage leads to ascites and liver cirrhosis; 9. Use of benzodiazepines or opioids within 24 hours before gastrointestinal endoscopy; 10. Uncontrolled hypertension, myocardial infarction, ischemic cardiomyopathy or taking beta-Receptor blockers; 11. A history or possibility of difficult airway, such as obstructive sleep apnea syndrome; 12. Mouth opening < 3cm, radiation injury or tumor of neck, instability of cervical spine; 13. Upper airway diseases, such as a history of upper respiratory tract infection within two weeks.

Design outcomes

Primary

Measure	Time frame
Unit propofol;	—

Secondary

Measure	Time frame
General Information of Patients;The number of patients with "failure" or "success" reaction during and within 1 min after gastroscopy implantation after induction;Total dosage of propofol during the entire gastroscopy and colonoscopy procedure;Total amount of propofol supplementation after induction;Frequency of propofol supplementation;The time required for gastroscopy + colonoscopy;Modified Observer's Alertness/Sedation scale (MOAA/S);Improved Aldrete score;Open eye time;PACU residence time;Adverse Events;Patient satisfaction with the procedure;Endoscopists' satisfaction with the procedure;	—

Measure

Time frame

General Information of Patients;The number of patients with "failure" or "success" reaction during and within 1 min after gastroscopy implantation after induction;Total dosage of propofol during the entire gastroscopy and colonoscopy procedure;Total amount of propofol supplementation after induction;Frequency of propofol supplementation;The time required for gastroscopy + colonoscopy;Modified Observer's Alertness/Sedation scale (MOAA/S);Improved Aldrete score;Open eye time;PACU residence time;Adverse Events;Patient satisfaction with the procedure;Endoscopists' satisfaction with the procedure;

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Countries

China

Contacts

Public ContactXue Fushan

Beijing Friendship Hospital, Capital Medical University

xuefushan@aliyun.com+86 10 6313 8761

Outcome results