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Completed

NCT Number: NCT05737459

Sedation and Postoperative Cognitive Functions

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.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Mental Disorders Neurocognitive Disorders Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Izmir Katip Çelebi University Atatürk Training and Research Hospital

Izmir, 35360, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. noninvasive mean arterial pressure

    Time frame: 6 months

    The effect of sedation on perioperative hemodynamics.

  2. The heart rate

    Time frame: 6 months

    The effect of sedation on perioperative hemodynamics.

Sponsors and collaborators

Lead sponsor

Izmir Ataturk Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2023
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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