NCT06976996

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

May 2, 2025

Last Update Submit

May 10, 2025

Conditions

Quality of Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery-15

    The QoR-15 (Quality of Recovery-15) evaluates the quality of recovery across five dimensions: physical comfort (50 points), emotional state (40 points), physical independence (20 points), psychological support (20 points), and pain (20 points). The total score of the QoR-15 ranges from 0 (indicating the poorest quality of recovery) to 150 (representing the best quality of recovery).

    Postoperative day 1 and 3

Secondary Outcomes (9)

  • Perioperative vital signs

    Perioperative

  • Anesthesia Recovery Time

    during surgery and arrived at PACU (up to 30 minutes after surgery)

  • Procedure Duration

    during surgery and arrived at PACU (up to 30 minutes after surgery)

  • PACU residence time

    during surgery and arrived at PACU (up to 30 minutes after surgery)

  • Anesthetic drug use

    during surgery and arrived at PACU (up to 30 minutes after surgery)

  • +4 more secondary outcomes

Study Arms (5)

group C

PLACEBO COMPARATOR

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

Drug: normal salineDrug: ciprofol

group E

EXPERIMENTAL

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

Drug: esketamineDrug: ciprofol

group P

EXPERIMENTAL

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

Drug: esketamineDrug: propofol

group EC

EXPERIMENTAL

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

Drug: esketamineDrug: etomidate-ciprofol (EC) mixture

group EP

EXPERIMENTAL

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

Drug: esketamineDrug: etomidate-propofol (EP) mixture

Interventions

normal salineDRUG

normal saline (0.15 ml/kg)

group C
esketamineDRUG

esketamine (0.15 mg/kg)

Also known as: S-ketamine
group Egroup ECgroup EPgroup P
propofolDRUG

propofol (2 mg/kg)

group P
etomidate-ciprofol (EC) mixtureDRUG

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

group EC
ciprofolDRUG

ciprofol (0.5 mg/kg)

group Cgroup E
etomidate-propofol (EP) mixtureDRUG

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

group EP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • （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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 22500, China

Location

MeSH Terms

Interventions

Saline SolutionEsketaminePropofol(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 16, 2025

Study Start

March 16, 2025

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations

CN(1)