Efficacy of Esketamine Combined With Different General Anesthetics on Quality of Postoperative Recovery

Northern Jiangsu People's Hospital

Status: Active, not recruiting

Conditions: Quality of Postoperative Recovery

Treatments: Drug: etomidate-propofol (EP) mixture; Drug: normal saline; Drug: ciprofol; Drug: propofol; Drug: esketamine; Drug: etomidate-ciprofol (EC) mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT06976996

2025ky074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 5 patient groups, including a placebo group

group C

Placebo Comparator group

Description:

normal saline (0.15 ml/kg) + ciprofol (0.5 mg/kg)

Treatment:

Drug: ciprofol

Drug: normal saline

group E

Experimental group

Description:

esketamine (0.15 mg/kg) + ciprofol (0.5 mg/kg)

Treatment:

Drug: esketamine

Drug: ciprofol

group P

Experimental group

Description:

esketamine (0.15 mg/kg) + propofol (2 mg/kg)

Treatment:

Drug: esketamine

Drug: propofol

group EC

Experimental group

Description:

esketamine (0.15 mg/kg) + etomidate-ciprofol (EC) mixture (0.2 ml/kg)

Treatment:

Drug: etomidate-ciprofol (EC) mixture

Drug: esketamine

group EP

Experimental group

Description:

esketamine (0.15 mg/kg) + etomidate-propofol (EC) mixture (0.2 ml/kg)

Treatment:

Drug: esketamine

Drug: etomidate-propofol (EP) mixture