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

NCT ID: NCT06617039

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Quality of Postoperative Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ciprofol group (C group)

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

Group Type ACTIVE_COMPARATOR

Ciprofol

Intervention Type DRUG

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

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

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

Group Type EXPERIMENTAL

Remifentanil and ciprofol

Intervention Type DRUG

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

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

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

Group Type EXPERIMENTAL

esketamine 0.3mg/kg and ciprofol

Intervention Type DRUG

Anesthesia induction was initiated by esketamine 0.3mg/kg, followed by ciprofol 0.2-0.4mg/kg.

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

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

Group Type EXPERIMENTAL

esketamine 0.5mg/kg and ciprofol

Intervention Type DRUG

Anesthesia induction was initiated by esketamine 0.5mg/kg, followed by ciprofol 0.2-0.4mg/kg.

Interventions

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Remifentanil and ciprofol

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

Intervention Type DRUG

esketamine 0.3mg/kg and ciprofol

Anesthesia induction was initiated by esketamine 0.3mg/kg, followed by ciprofol 0.2-0.4mg/kg.

Intervention Type DRUG

esketamine 0.5mg/kg and ciprofol

Anesthesia induction was initiated by esketamine 0.5mg/kg, followed by ciprofol 0.2-0.4mg/kg.

Intervention Type DRUG

Ciprofol

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northern Jiangsu People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ju Gao

Study Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Subei People's Hospital of Jiangsu Province

Yangzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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2024ky251

Identifier Type: -

Identifier Source: org_study_id

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