NCT06617039
Active, not recruiting
Not Applicable
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 Hospital1 site in 1 country376 target enrollmentStarted: October 10, 2024Last updated:
ConditionsQuality of Postoperative Recovery
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Northern Jiangsu People's Hospital
- Enrollment
- 376
- Locations
- 1
- Primary Endpoint
- postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Ciprofol group (C group)
Active Comparator
Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg.
Intervention: Ciprofol (Drug)
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.
Intervention: Remifentanil and ciprofol (Drug)
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.
Intervention: esketamine 0.3mg/kg and ciprofol (Drug)
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.
Intervention: esketamine 0.5mg/kg and ciprofol (Drug)
Outcomes
Primary Outcomes
postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
Time Frame: 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 Outcomes
- 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))
- Pulse oxygen saturation (SpO2)(Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery))
- Mean blood pressure (MBP)(Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery))
- Patient satisfaction levels(30 minutes at recovery room.)
Investigators
Ju Gao
Study Director
Northern Jiangsu People's Hospital
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast CancerDepressionNCT04850937Yangzhou University90
Completed
Not Applicable
The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic SurgeryPostoperative PainNCT06300944General Hospital of Ningxia Medical University100
Completed
Phase 3
Effect of low-dose esketamine on postoperative delirium in patients undergoing noncardiac surgery.Postoperative confusion after noncardiac surgery1001222110043413NL-OMON38654Erasmus MC, Universitair Medisch Centrum Rotterdam70
Unknown
Not Applicable
Esketamine vs. Ketorolac for Prevention of Postoperative Pain and Cognitive Dysfunction After Total Knee ArthroplastyPostoperative PainPostoperative Cognitive DysfunctionTotal Knee ArthroplastyNCT05132595Tianjin Medical University General Hospital160
Completed
Not Applicable
Postoperative Analgesic Effect of EsketamineGynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed LaborAnalgesiaNCT05582135Xuanhan County People's Hospital119