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To compare the incidence of hypotension in elderly patients undergoing painless gastroenteroscopy with esketamine or sufentanil combined with propofol

Comparative study of subanesthetic dose esketamine or sufentanil combined with propofol in the incidence of low blood pressure in elderly patients undergoing painless gastroenteroscopy: A randomized double-blind controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088855
Enrollment
Unknown
Registered
2024-08-28
Start date
2024-09-02
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Painless gastrointestinal endoscopy

Interventions

Group A:Esketamine(0.25mg/kg)+propofol(1 mg/kg)
Group B:Sufentanil(0.05ug/kg)+propofol(1 mg/kg)

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 65-80 years old; (2) Body mass index 18-30kg /m^2; (3) Patients to undergo gastroenteroscopy; (4) ASA grade I-III with normal heart function or NHYA grade I-II; (5) The patient volunteered to be tested and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Blood pressure =180/110 mm Hg before entry (WHO-ISH hypertension refers to grade 3 hypertension); (2) Patients with serious risk of intracranial hypertension, such as intracranial tumor, intracranial infection, intracranial hemorrhage, etc.; (3) severe liver and kidney dysfunction; (4) There are contraindications or allergies to the experimental drug and other narcotic drugs; (5) untreated or poorly controlled hyperthyroidism; (6) Patients with high intraocular pressure such as glaucoma; (7) Those who are taking reserpine; (8) Patients with severe auditory, visual, and language system functional impairment who cannot cooperate with the researcher's visit; (9) Confirmed/suspected abuse or long-term use of narcotic sedatives and analgesics; (10) Patients enrolled in other studies within 30 days; (11) Refuse to participate.

Design outcomes

Primary

MeasureTime frame
Incidence of hypotension;

Secondary

MeasureTime frame
Hemodynamic parameters including SBP, MAP, HR and SPO2 (hypoxemia: T0) were observed before anesthesia in patients lying on their side for 5 minutes (T0), gastroscopy at throat (T1), enteroscopy at beginning (T2), enteroscopy at liver flexure (T3), awakening (T4), entering PACU(T5) and exiting PACU(T6). SPO2<90%) and respiratory rate.;The total propofol dose, examination time (the time when the endoscope began to be inserted until the endoscope was completely withdrawn), recovery time (the time when the examination stopped until the patient could automatically open his eyes and act according to the instructions), and PACU residence time (the time when he could walk out of the recovery room accompanied by his family after recovery) were recorded.;The number of cases of respiratory depression, choking, body movement, nausea and vomiting, as well as postoperative adverse reactions such as dizziness, blurred vision, drowsiness and hallucination were recorded.;Evaluate the postoperative satisfaction of patients and endoscopists.;

Countries

China

Contacts

Public ContactLingli Cui

Beijing Friendship Hospital, Capital Medical University

clinly@126.com+86 10 6313 8761

Outcome results

None listed

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