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

NCT06617039 | Active Not Recruiting

• 1 other identifier: 2024ky251
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Quality of Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score

  Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value : 0, maximum value : 150, the higher the score, the better the result)

  Baseline (30 min before surgery), postoperative day 1

Secondary Outcomes (8)

• postoperative day 3(POD3) Quality of Recovery(QoR)-15 questionnaire score

  Postoperative day 3 and 7

• Cognitive function assessment

  Baseline (30 min before surgery), postoperative day 1,3 and 7

• Hospital anxiety and depression scale ( HADS ) score.

  Baseline (30 min before surgery), postoperative day 1,3 and 7

• Dosage of ciprofol

  During endoscopic examination

• Heart rate (HR)

  Baseline，during surgery and arrived at PACU (up to 30 minutes after surgery)

Other Outcomes (1)

• The incidence of all drug-related adverse events

  Within 72hours after surgery

Study Arms (4)

Ciprofol group (C group)

ACTIVE COMPARATOR

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

Drug: Ciprofol

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

EXPERIMENTAL

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

Drug: Remifentanil and ciprofol

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

EXPERIMENTAL

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

Drug: esketamine 0.3mg/kg and ciprofol

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

EXPERIMENTAL

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

Drug: esketamine 0.5mg/kg and ciprofol

Interventions

Remifentanil and ciprofol DRUG

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

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

esketamine 0.3mg/kg and ciprofol DRUG

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

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

esketamine 0.5mg/kg and ciprofol DRUG

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

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

Ciprofol DRUG

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

Ciprofol group (C group)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Scheduled painless gastroscopy examination and treatment
• \. Age 60-75 years old
• \. ASA grade Ⅰ-Ⅱ
• \. The respiratory tract is unobstructed and there is no difficult airway
• \. No history of allergy to etomidate and cyclopropofol
• \. Participants with normal heart, liver, lung, and kidney functions
• \. Able to complete the QoR-15, MMSE, and HADS scale assessments
• \. lnformed consent, voluntary participation in the trial, and signed by the patient informed consent

You may not qualify if:

• \. Participants with concurrent dysfunction of major organs.
• \. Participants with a history of mental illness and abuse of sedative drugs
• \. Participants with allergies or contraindications to the study drugs
• \. Participants with severe visual, auditory, or speech communication impairments
• \. Participants with acute gastrointestinal inflammation or obstruction
• \. History of uncontrolled diabetes, hypertension, and hypotension
• \. Participants with malignant tumors, severe hyperkalemia, bronchial asthma, or excessive obesity (BMI \> 30kg/m2)
• \. Participants with aneurysmal vascular diseases of the thoracic and abdominal aorta, intracranial and peripheral arterial vessels.
• \. Unable to cooperate with the QoR-15, MMSE, and HADS scale assessments

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Subei People's Hospital of Jiangsu Province

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Interventions

Remifentanil; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Esketamine

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 27, 2024
• Study Start: October 10, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)