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

Not Applicable

Active, not recruiting

• Conditions: Quality of Postoperative Recovery
• Interventions: Drug: Remifentanil and ciprofol; Drug: esketamine 0.3mg/kg and ciprofol; Drug: Ciprofol; Drug: esketamine 0.5mg/kg and ciprofol

• Registration Number: NCT06617039
• Lead Sponsor: Northern Jiangsu People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-27
• Study Start: 2024-10-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-07-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 376

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The group of remifentanil 0.5ug/kg combined with ciprofol(R group)	Remifentanil and ciprofol	R group will be started with remifentanil 0.5ug/kg and ciprofol 0.2-0.4 mg/kg.
The group of esketamine 0.3mg/kg combined with ciprofol(E1 group)	esketamine 0.3mg/kg and ciprofol	E1 group will be started with esketamine 0.3mg/kg and ciprofol 0.2-0.4 mg/kg.
Ciprofol group (C group)	Ciprofol	Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg.
The group of esketamine 0.5mg/kg combined with ciprofol(E2 group)	esketamine 0.5mg/kg and ciprofol	E2 group will be started with esketamine 0.5mg/kg and ciprofol 0.2-0.4 mg/kg.

Primary Outcome Measures

Name	Time	Method
postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score	Baseline (30 min before surgery), postoperative day 1	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)

Secondary Outcome Measures

Name	Time	Method
postoperative day 3(POD3) Quality of Recovery(QoR)-15 questionnaire score	Postoperative day 3 and 7	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)
Cognitive function assessment	Baseline (30 min before surgery), postoperative day 1,3 and 7	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.
Hospital anxiety and depression scale ( HADS ) score.	Baseline (30 min before surgery), postoperative day 1,3 and 7	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.
Dosage of ciprofol	During endoscopic examination	Consumption of ciprofol during endoscopic examination
Heart rate (HR)	Baseline，during surgery and arrived at PACU (up to 30 minutes after surgery)	Throughout the procedure, the heart rate (HR) was continuously monitored.
Pulse oxygen saturation (SpO2)	Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)	Throughout the procedure, the pulse oxygen saturation (SpO2) were continuously monitored.
Mean blood pressure (MBP)	Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)	Throughout the procedure, the mean blood pressure (MBP) was measured at 1-minute intervals.
Patient satisfaction levels	30 minutes at recovery room.	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.

Trial Locations

Locations (1)

Subei People's Hospital of Jiangsu Province; 🇨🇳 Yangzhou, Jiangsu, China