Clinical trial NCT06976996: Efficacy of Esketamine Combined With Different General Anesthetics on Quality of Postoperative Recovery
Official title: Efficacy of Subanesthetic Dose of Esketamine Combined With Different General Anesthetics on Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy
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: 2025-05-16
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the effect of subanesthetic-dose esketamine combined with different general anesthetic drugs on the quality of postoperative recovery in patients undergoing painless gastrointestinal endoscopy.

Detailed description: In this study, we planned to conduct a single-center, prospective, randomized, controlled, double-blind clinical trial to explore the effect of subanesthetic dose esketamine combined with different general anesthesia drugs on the postoperative recovery quality of patients undergoing painless gastrointestinal endoscopy combined with several commonly used intravenous general anesthesia drugs, aiming at gastroscopy combined with colonoscopy, a representative type of diagnosis and treatment of painless and comfortable anesthesia, and to provide more evidence-based medical evidence for clinical work.

Eligibility criteria: Inclusion Criteria:

* (1) Aged between 18 and 75 years old (inclusive); (2) ASA (American Society of Anesthesiologists) physical status classification of Class I to III; (3) Body Mass Index (BMI) ranging from 18 to 30 kg/m²; (4) Individuals scheduled to undergo combined gastroscopy and colonoscopy under painless anesthesia; (5) Those with a patent airway and no history of difficult intubation or difficult airway management; (6) Individuals with intact cognitive function, who have provided informed consent, voluntarily participate in this study, and are capable of cooperating to complete data collection.

Exclusion Criteria:

* （1）A history of unregulated diabetes mellitus, hypertension, or hypotension; （2）Concomitant hyperthyroidism or hypothyroidism; （3）Concomitant psychiatric or neurological disorders; （4）Severe hepatic or renal insufficiency; （5）Concomitant glaucoma, severe hearing or visual impairment that hinders cooperation; （6）Individuals with significant organ dysfunction; （7）Those with allergies to or contraindications for the study drug; （8）Patients with aneurysmal vascular diseases involving the thoracic or abdominal aorta, intracranial arteries, or peripheral arterial vessels; （9）Individuals who are unable to cooperate in completing the Quality of Recovery-15 (QoR-15) questionnaire.

Primary outcomes:
measure: Quality of Recovery-15
timeFrame: Postoperative day 1 and 3
Secondary outcomes:
measure: Perioperative vital signs
timeFrame: Perioperative
measure: Anesthesia Recovery Time
timeFrame: during surgery and arrived at PACU (up to 30 minutes after surgery)
measure: Procedure Duration
timeFrame: during surgery and arrived at PACU (up to 30 minutes after surgery)
measure: PACU residence time
timeFrame: during surgery and arrived at PACU (up to 30 minutes after surgery)
measure: Anesthetic drug use
timeFrame: during surgery and arrived at PACU (up to 30 minutes after surgery)
measure: The way the patient leaves the endoscopy center
timeFrame: Postoperative
measure: The length of the patient's stay in the hospital after leaving the endoscopy center in the PACU
timeFrame: Postoperative
measure: The way the patient leaves the hospital
timeFrame: Postoperative
measure: Satisfaction score
timeFrame: Postoperative
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References: