NCT05737459

Brief Summary

Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. Patients who were given ketamine and dexmedetomidine for sedation were included in the study. The Mini Mental Status Tests of the patients measured on the first and third days of the operation in the preoperative period were determined from the hospital records and recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

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

May 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

February 2, 2023

Last Update Submit

February 20, 2023

Conditions

Keywords

Cognitive ImpairmentMini mental status testHip fracturesKetaminedexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • Mini-Mental Status Test

    Evaluation of the effect of sedation with ketamine and dexmedetomidine on postoperative cognitive functions by Mini-Mental Status Test

    6 months

Secondary Outcomes (2)

  • noninvasive mean arterial pressure

    6 months

  • The heart rate

    6 months

Study Arms (2)

Group K

Those who have been administered ketamine for perioperative sedation

Group D

Those who have been administered dexmedetomidine for perioperative sedation.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients sedated with ketamine and dexmedetomidine during spinal anesthesia for hip fracture

You may qualify if:

  • Patients over the age of 65 who underwent surgery under spinal anesthesia due to hip fracture
  • Volunteered to participate in the study

You may not qualify if:

  • Patients who are under the age of 65
  • Patients with known histories of dementia
  • Patients with Alzheimer's disease
  • Patients with central nervous system disease
  • Patients who scored 15 or less according to the Mini Mental Status Test (MMSE)
  • Patients who underwent surgery under general anesthesia
  • Patients who refused to voluntarily participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Çelebi University Atatürk Training and Research Hospital

Izmir, 35360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cognitive DysfunctionFemoral FracturesHip Fractures

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersFractures, BoneWounds and InjuriesLeg InjuriesHip Injuries

Study Officials

  • Derya A Yurtlu, M.D.

    Izmir Katip Celebi University Atatürk Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 21, 2023

Study Start

May 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations