NCT04691076

Brief Summary

Purpose: 1. To determine the efficacy of low-dose esketamine in painless gastrointestinal endoscopy. 2. To determine the safety of low-dose esketamine in painless gastrointestinal endoscopy. 3. To provide a theoretical basis and new ideas for the application of esketamine as a new drug in perioperative period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

December 29, 2020

Last Update Submit

December 30, 2020

Conditions

PainAnesthesia

Keywords

Esketamine; Gastrointestinal endoscopy; Analgesia; Sedation; Respiratory depression

Outcome Measures

Primary Outcomes (1)

  • Cumulative propofol Consumption

    Total amount of propofol administered intraoperatively

    intraoperative

Secondary Outcomes (5)

  • The incidence of adverse events in pulmonary and circulatory systems

    During the operation

  • Time of recovery, post-anaesthesia care unit and discharge from hospital

    procedure ( the end of endoscopy removal)

  • The incidence of side effects of esketamine

    Intraoperative

  • The number of patients'body movement during operation

    During the operation

  • The satisfaction of the endoscopist and patient

    24 hours after surgery

Study Arms (2)

Propofol/Esketamine sedation

EXPERIMENTAL

Propofol target-controlled infusion is performed first,when the infusion concentration reaches 1.5μg/ml,esketamine 0.15mg/kg is injected intravenously;then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration, the corresponding increase of esketamine is 0.05mg/kg; the total dose of esketamine used in surgery shall not exceed 0.5mg/kg.

Drug: PropofolDrug: Esketamine

Propofol/Fentanyl sedation

ACTIVE COMPARATOR

Propofol target-controlled infusion is performed first.When the infusion concentration reaches 1.5μg/ml, fentanyl 0.6μg/kg is injected intravenously; then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration,the corresponding increase of fentanyl is 0.2ug/kg; the total dose of fentanyl used in surgery shall not exceed 1.2ug/kg.

Drug: PropofolDrug: Fentanyl

Interventions

PropofolDRUG

Propofol is administered by target-controlled infusion

Propofol/Esketamine sedationPropofol/Fentanyl sedation
EsketamineDRUG

Esketamine is intravenously administrated

Propofol/Esketamine sedation
FentanylDRUG

Fentanyl is intravenously administrated

Propofol/Fentanyl sedation

Eligibility Criteria

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

You may qualify if:

  • Subject's American Society of Anesthesiologists physical status is I-III.
  • Subject has no symptoms of allergy to anesthetics.
  • Subject has no contraindications for gastrointestinal endoscopy.
  • Subject has given written informed consent to participate.

You may not qualify if:

  • Subject's BMI \<18 or \>30
  • Subject has poorly controlled or untreated hypertension.
  • Subject has severe ischemic heart disease.
  • Subject is an untreated or undertreated patient with hyperthyroidism.
  • Subject has used drugs that affect their central nervous system.
  • Subject has mental illness.
  • Subject has epilepsy.
  • Subject has a history of chronic pain.
  • Subject is pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Union Medical Center

Tianjin, 300131, China

RECRUITING

MeSH Terms

Conditions

PainAgnosiaRespiratory Insufficiency

Interventions

PropofolEsketamineFentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Tao Yang

    Tianjin Union Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Yang, Master

CONTACT

18920802290yangtao@nankai.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2020

First Posted

December 31, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

February 1, 2022

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations

CN(1)