Clinical trial NCT06617039: The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy
Official title: The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Quality of Postoperative Recovery
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 376
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 \&gt; 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

Primary outcomes:
measure: postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
timeFrame: Baseline (30 min before surgery), postoperative day 1
Secondary outcomes:
measure: postoperative day 3(POD3) Quality of Recovery(QoR)-15 questionnaire score
timeFrame: Postoperative day 3 and 7
measure: Cognitive function assessment
timeFrame: Baseline (30 min before surgery), postoperative day 1,3 and 7
measure: Hospital anxiety and depression scale ( HADS ) score.
timeFrame: Baseline (30 min before surgery), postoperative day 1,3 and 7
measure: Dosage of ciprofol
timeFrame: During endoscopic examination
measure: Heart rate (HR)
timeFrame: Baseline，during surgery and arrived at PACU (up to 30 minutes after surgery)
measure: Pulse oxygen saturation (SpO2)
timeFrame: Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)
measure: Mean blood pressure (MBP)
timeFrame: Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)
measure: Patient satisfaction levels
timeFrame: 30 minutes at recovery room.
Other outcomes:
measure: The incidence of all drug-related adverse events
timeFrame: Within 72hours after surgery
Locations:
city: Yangzhou
country: China
facility: Subei People&#39;s Hospital of Jiangsu Province
state: Jiangsu
Study officials:
References: