Sedation and Postoperative Cognitive Functions

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05737459
• Other study ID #: IAERH
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Izmir Ataturk Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Femoral Fractures
• Fractures, Bone

Locations

Country	Name	City	State
Turkey	Izmir Katip Çelebi University Atatürk Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Ataturk Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	noninvasive mean arterial pressure	The effect of sedation on perioperative hemodynamics.	6 months
Secondary	The heart rate	The effect of sedation on perioperative hemodynamics.	6 months