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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Postoperative Recovery
• Intervention / Treatment: Drug: Ciprofol; Drug: Remifentanil and ciprofol; Drug: esketamine 0.3mg/kg and ciprofol; Drug: esketamine 0.5mg/kg and ciprofol

• Study Type: Interventional
• Enrollment (Estimated): 376
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • Subei People's Hospital of Jiangsu province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ciprofol group (C group); Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg.	Drug: Ciprofol; Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg.
Experimental: 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.	Drug: Remifentanil and ciprofol; R group will be started with remifentanil 0.5ug/kg and ciprofol 0.4 mg/kg.
Experimental: 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.	Drug: esketamine 0.3mg/kg and ciprofol; Anesthesia induction was initiated by esketamine 0.3mg/kg, followed by ciprofol 0.2-0.4mg/kg.
Experimental: 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.	Drug: esketamine 0.5mg/kg and ciprofol; Anesthesia induction was initiated by esketamine 0.5mg/kg, followed by ciprofol 0.2-0.4mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative day 3(POD3) Quality of Recovery(QoR)-15 questionnaire score	Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 3(minimum value : 0, maximum value : 150, the higher the score, the better the result)	Postoperative day 3 and 7
Cognitive function assessment	A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). MMSE has a maximum total score of 30, with higher scores manifesting a better cognitive performance.	Baseline (30 min before surgery), postoperative day 1,3 and 7
Hospital anxiety and depression scale ( HADS ) score.	Postoperative anxiety and depression scores will be measured by the Hospital Anxiety and Depression Scale, on the morning(8-10 am) of postoperative days (PODs) 1,3 and 7 , a score of 8 points or higher will be diagnosed as depression or anxiety.	Baseline (30 min before surgery), postoperative day 1,3 and 7
Dosage of ciprofol	Consumption of ciprofol during endoscopic examination	During endoscopic examination
Heart rate (HR)	Throughout the procedure, the heart rate (HR) was continuously monitored.	Baseline，during surgery and arrived at PACU (up to 30 minutes after surgery)
Pulse oxygen saturation (SpO2)	Throughout the procedure, the pulse oxygen saturation (SpO2) were continuously monitored.	Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)
Mean blood pressure (MBP)	Throughout the procedure, the mean blood pressure (MBP) was measured at 1-minute intervals.	Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)
Patient satisfaction levels	The patients express their satisfaction with procedures on a visual analogue score, ranging from 0 to 10, where 0 is the minimum and 10 is the maximum satisfaction level.	30 minutes at recovery room.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of all drug-related adverse events	All drug-related adverse events including bradycardia, hypotension, tachycardia, hypertension, arrhythmia, nystagmus, hypersalivation, euphoria, emergence agitation, hallucinations, dreaminess and nightmares during surgery or before discharge.etc.Patients will be followed up for 3 days consecutively(at 8-10am).	Within 72hours after surgery

Collaborators and Investigators

• Sponsor: Northern Jiangsu People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Antidepressive Agents; Remifentanil; Esketamine
• Other Study ID Numbers: 2024ky251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No