NCT04969523

Brief Summary

The purpose of this study is the efficiency of es-ketamine on postoperative delirium among old patients with elective lobectomy

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

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

First Submitted

Initial submission to the registry

May 19, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

July 31, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

May 19, 2021

Last Update Submit

July 8, 2021

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

  • Postoperative Delirium

    Confusion Assessment Method (CAM) or CAM-ICU for patients

    7 days after operation

  • Postoperative Cognitive Assessment

    Montreal Cognitive Assessment

    7 days after operation

Study Arms (2)

es-ketamine

EXPERIMENTAL

es-ketamine 0.5mg/kg iv

Procedure: lobectomy

saline

PLACEBO COMPARATOR

iv saline with the same volume of es-ketamine

Procedure: lobectomy

Interventions

lobectomyPROCEDURE

Intravenous es-ketamine 0.5mg/kg or saline during lobectomy

es-ketaminesaline

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old; There is no limit on the gender, ASA (American Society of Anesthesiologists )Ⅰ-Ⅲ

You may not qualify if:

  • Emergency surgery, severe hepatic and renal dysfunction, shock or coma, psychiatric disease or central nervous system disorder or a history of long-term use of psychiatric medications, cognitive dysfunction, severe arrhythmia or bradycardia, ketamine allergy,drug abuse history and used other sedatives for nearly a week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergence Delirium

Interventions

Anterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeNeurosurgical Procedures

Study Design

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

Study Record Dates

First Submitted

May 19, 2021

First Posted

July 20, 2021

Study Start

July 31, 2021

Primary Completion

June 30, 2022

Study Completion

December 31, 2022

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share