NCT00590707

Brief Summary

This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 11, 2018

Completed
Last Updated

June 11, 2018

Status Verified

May 1, 2018

Enrollment Period

12.3 years

First QC Date

December 28, 2007

Results QC Date

April 10, 2018

Last Update Submit

May 11, 2018

Conditions

Hip FracturesDelirium

Keywords

Hip fracturesFemoral neck fracturesTrochanteric fracturesIntertrochanteric fracturesSubtrochanteric fracturesDeliriumConfusion

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method

    The presence of delirium is assessed by the confusion assessment method (CAM), during postoperative Day 1 to Day 5 or up to hospital discharge, whichever occurs first. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.

    Postoperative days up to hospital discharge

Secondary Outcomes (4)

  • Change in Functional Status

    12 months post-operative

  • Mortality

    12 months post-operative

  • Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method

    1 month (30 days) post-intervention

  • Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score

    12 months post-operative

Study Arms (2)

Deeper sedation

ACTIVE COMPARATOR

Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.

Device: Deeper sedation

Moderate sedation

ACTIVE COMPARATOR

Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.

Device: Moderate sedation

Interventions

Deeper sedationDEVICE

The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.

Also known as: Observer's Assessment of Awareness/Sedation Scale (OAA/S)
Deeper sedation
Moderate sedationDEVICE

The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.

Also known as: Observer's Assessment of Awareness/Sedation Scale (OAA/S)
Moderate sedation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • is 65 years of age or older at admission;
  • has surgical treatment of a traumatic hip fracture;
  • has participating surgeon;
  • has Mini-Mental Status Exam score of 15 or higher;
  • able to read/write/speak/hear/understand English;
  • gives informed consent;
  • receives spinal anesthesia

You may not qualify if:

  • receives general anesthesia;
  • does not write/write/speak/hear/understand English;
  • has severe chronic obstructive pulmonary disease (COPD);
  • has severe congestive heart failure (CHF);
  • has Mini-Mental Status Exam score less than 15;
  • declines to give informed consent;
  • age less than 65 years at admission;
  • attending surgeon does not participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Sieber F, Neufeld KJ, Gottschalk A, Bigelow GE, Oh ES, Rosenberg PB, Mears SC, Stewart KJ, Ouanes JP, Jaberi M, Hasenboehler EA, Wang NY. Depth of sedation as an interventional target to reduce postoperative delirium: mortality and functional outcomes of the Strategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients randomised clinical trial. Br J Anaesth. 2019 Apr;122(4):480-489. doi: 10.1016/j.bja.2018.12.021. Epub 2019 Feb 4.

    PMID: 30857604DERIVED

  • Sieber FE, Neufeld KJ, Gottschalk A, Bigelow GE, Oh ES, Rosenberg PB, Mears SC, Stewart KJ, Ouanes JP, Jaberi M, Hasenboehler EA, Li T, Wang NY. Effect of Depth of Sedation in Older Patients Undergoing Hip Fracture Repair on Postoperative Delirium: The STRIDE Randomized Clinical Trial. JAMA Surg. 2018 Nov 1;153(11):987-995. doi: 10.1001/jamasurg.2018.2602.

    PMID: 30090923DERIVED

  • Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. doi: 10.4065/mcp.2009.0469.

    PMID: 20042557DERIVED

MeSH Terms

Conditions

Hip FracturesDeliriumFemoral Neck FracturesConfusion

Interventions

Conscious Sedation

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Results Point of Contact

Title
frederick Sieber
Organization
Johns Hopkins
fsieber1@jhmi.edu
410-550-0942

Study Officials

  • Frederick E. Sieber, MD

    Dept. of Anesthesiology and Critical Care Medicine, School of Medicine, The Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 11, 2008

Study Start

January 1, 2005

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

June 11, 2018

Results First Posted

June 11, 2018

Record last verified: 2018-05

Locations

US(1)