Sequential Determination of the Effective Dose of Affentanil Combined with Reimazolam for Painless Gastrointestinal Endoscopy under Wrist-Ankle Acupuncture

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200067003

Enrollment

Unknown

Registered

2022-12-23

Start date

2023-01-01

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Gastroenteroscopy

Interventions

Young women's group:Phase 1: wrist-ankle acupuncture + 3 ug/kg of alfentanil + remifentanil (modified sequential administration)

Phase 2: wrist-ankle acupuncture + fentanyl (modified sequential administration) + remifentanil ED95 dose.

Young men's group:Phase 1: wrist-ankle acupuncture + 3 ug/kg of alfentanil + remifentanil (modified sequential administration)

Senior Women's Group:Phase 1: wrist-ankle acupuncture + 3 ug/kg of alfentanil + remifentanil (modified sequential administration)

Senior Male Group:Phase 1: wrist-ankle acupuncture + 3 ug/kg of alfentanil + remifentanil (modified sequential administration)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Voluntarily accept painless gastrointestinal endoscopy patients, gender is not limited; 2. Aged >= 18 years old; His cardiopulmonary function was good, and he met ASA (American Association of Anesthesiologists) Class I–III standards, and he had no other severe system combined diseases; 3. The patient has no experience of wrist-ankle acupuncture; 4. Those who volunteered for the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Emergency examination; 2. There are other serious system complications or mental disorders or other reasons can not cooperate; 3. Lactation, pregnancy women; 4. Allergic constitution and long-term use of hormone drugs; 5. Those who did not voluntarily participate in the experiment; 6. Taking psychotropic drugs; 7. Gastrointestinal endoscopy.

Design outcomes

Primary

Measure	Time frame
ED50 and ED95 of mizolam and alfentanil; ED50 differences between young men and women, older men and women;	—

Secondary

Measure	Time frame
Incidence of swallowing, vomiting, cough, body movement and postoperative nausea, vomiting, hiccup and hiccup in our patient;Heart rate, blood pressure, blood oxygen saturation;	—

Countries

China

Contacts

Public ContactWei Hao

Hebei Provincial Hospital of Traditional Chinese Medicine

hao_wei800@163.com+86 138 3212 2359

Outcome results

None listed

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