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

NCT ID: NCT06976996

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-16

Study Completion Date

2025-12-15

Brief Summary

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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

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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.

Conditions

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Quality of Postoperative Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group C

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

normal saline (0.15 ml/kg)

ciprofol

Intervention Type DRUG

ciprofol (0.5 mg/kg)

group E

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

Group Type EXPERIMENTAL

esketamine

Intervention Type DRUG

esketamine (0.15 mg/kg)

ciprofol

Intervention Type DRUG

ciprofol (0.5 mg/kg)

group P

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

Group Type EXPERIMENTAL

esketamine

Intervention Type DRUG

esketamine (0.15 mg/kg)

propofol

Intervention Type DRUG

propofol (2 mg/kg)

group EC

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

Group Type EXPERIMENTAL

esketamine

Intervention Type DRUG

esketamine (0.15 mg/kg)

etomidate-ciprofol (EC) mixture

Intervention Type DRUG

etomidate-ciprofol (EC) mixture (0.2 ml/kg)

group EP

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

Group Type EXPERIMENTAL

esketamine

Intervention Type DRUG

esketamine (0.15 mg/kg)

etomidate-propofol (EP) mixture

Intervention Type DRUG

etomidate-propofol (EP) mixture (0.2 ml/kg)

Interventions

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normal saline

normal saline (0.15 ml/kg)

Intervention Type DRUG

esketamine

esketamine (0.15 mg/kg)

Intervention Type DRUG

propofol

propofol (2 mg/kg)

Intervention Type DRUG

etomidate-ciprofol (EC) mixture

etomidate-ciprofol (EC) mixture (0.2 ml/kg)

Intervention Type DRUG

ciprofol

ciprofol (0.5 mg/kg)

Intervention Type DRUG

etomidate-propofol (EP) mixture

etomidate-propofol (EP) mixture (0.2 ml/kg)

Intervention Type DRUG

Other Intervention Names

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S-ketamine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Jiangsu People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ju Gao

Study Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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2025ky074

Identifier Type: -

Identifier Source: org_study_id

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