Sedation and Postoperative Cognitive Functions

February 20, 2023 updated by: Derya Arslan Yurtlu, Izmir Ataturk Training and Research Hospital

The Effect of Sedation on Postoperative Cognitive Functions in Patients Operated for Hip Fracture Under Spinal Anesthesia

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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. The cognitive functions of these patients, which were evaluated by a Mini-Mental Test in the preoperative period, on the first and third days of surgery, were recorded from routine patient follow-up forms.

Sedation scores of the patients evaluated by Intraoperative Alertness/Sedation Scale (OAA/S) Observer Evaluation were recorded. Intraoperative hemodynamic data were recorded. The interventions applied to the patient were performed by anesthesiologists who were not involved in the study according to their preferences as part of the routine. The researchers were not involved in any intervention performed on the patient, only the data were recorded.

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey, 35360
        • Izmir Katip Celebi University Ataturk training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group K
Those who have been administered ketamine for perioperative sedation
Group D
Those who have been administered dexmedetomidine for perioperative sedation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Mental Status Test
Time Frame: 6 months
Evaluation of the effect of sedation with ketamine and dexmedetomidine on postoperative cognitive functions by Mini-Mental Status Test
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
noninvasive mean arterial pressure
Time Frame: 6 months
The effect of sedation on perioperative hemodynamics.
6 months
The heart rate
Time Frame: 6 months
The effect of sedation on perioperative hemodynamics.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Ataturk Training and Research Hospital

Investigators

  • Principal Investigator: Derya A Yurtlu, M.D., Izmir Katip Celebi University Ataturk training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Estimate)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAERH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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