The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy

Northern Jiangsu People's Hospital

Status: Active, not recruiting

Conditions: Quality of Postoperative Recovery

Treatments: Drug: Ciprofol; Drug: esketamine 0.3mg/kg and ciprofol; Drug: Remifentanil and ciprofol; Drug: esketamine 0.5mg/kg and ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06617039

2024ky251

Details and patient eligibility

About

To explore the impact of esketamine combined with ciprofol on the quality of early postoperative recovery in elderly patients undergoing painless gastroscopy, as well as the effectiveness and safety of this regimen.

Enrollment: 376 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Scheduled painless gastroscopy examination and treatment

  2. Age 60-75 years old

  3. ASA grade Ⅰ-Ⅱ

  4. The respiratory tract is unobstructed and there is no difficult airway

  5. No history of allergy to etomidate and cyclopropofol

  6. Participants with normal heart, liver, lung, and kidney functions

  7. Able to complete the QoR-15, MMSE, and HADS scale assessments

  8. lnformed consent, voluntary participation in the trial, and signed by the patient informed consent

Exclusion criteria

• 1. Participants with concurrent dysfunction of major organs.

  2. Participants with a history of mental illness and abuse of sedative drugs

  3. Participants with allergies or contraindications to the study drugs

  4. Participants with severe visual, auditory, or speech communication impairments

  5. Participants with acute gastrointestinal inflammation or obstruction

  6. History of uncontrolled diabetes, hypertension, and hypotension

  7. Participants with malignant tumors, severe hyperkalemia, bronchial asthma, or excessive obesity (BMI > 30kg/m2)

  8. Participants with aneurysmal vascular diseases of the thoracic and abdominal aorta, intracranial and peripheral arterial vessels.

  9. Unable to cooperate with the QoR-15, MMSE, and HADS scale assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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376 participants in 4 patient groups

Ciprofol group (C group)

Active Comparator group

Description:

Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg.

Treatment:

Drug: Ciprofol

The group of remifentanil 0.5ug/kg combined with ciprofol(R group)

Experimental group

Description:

R group will be started with remifentanil 0.5ug/kg and ciprofol 0.2-0.4 mg/kg.

Treatment:

Drug: Remifentanil and ciprofol

The group of esketamine 0.3mg/kg combined with ciprofol(E1 group)

Experimental group

Description:

E1 group will be started with esketamine 0.3mg/kg and ciprofol 0.2-0.4 mg/kg.

Treatment:

Drug: esketamine 0.3mg/kg and ciprofol

The group of esketamine 0.5mg/kg combined with ciprofol(E2 group)

Experimental group

Description:

E2 group will be started with esketamine 0.5mg/kg and ciprofol 0.2-0.4 mg/kg.

Treatment:

Drug: esketamine 0.5mg/kg and ciprofol