Clinical trial NCT05548998: Effect of Low Flow Anesthetics on Neurocognitive Decline in the Elderly
Official title: Effect of Low Fresh Gas Flow Volatile Anesthetics on Postoperative Neurocognitive Function in Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurocognitive Disorders
Inhalation; Vapor
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 230
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohorts were selected from geriatric patients (\>65 y.o.) of a tertiary care clinic who underwent surgery under general anesthesia with different fresh gas flows for the maintenance phase.

Brief summary: This study aims to investigate the effect of inhaled anesthetics with a low fresh gas flow on cognitive function of elderly patients undergoing elective surgery

Detailed description: Geriatric patients scheduled to undergo surgery were tested with Mini Mental State Examination (MMSE) in the preoperative visit. MMSE was repeated postoperatively at the 6th hour, the 1st, 3rd, and 7th day. Visual analogue scale (VAS) test was performed simultaneously on the postoperative 6th hour, the 1st, 3rd, and 7th day. Two cohorts were created according to the amount of fresh gas flow (low flow vs high flow) in the maintenance phase of the inhalational anesthetic. MMSE scores were compared between cohorts and baseline. VAS scores were compared between cohorts.

Eligibility criteria: Inclusion Criteria:

* Age\>65
* Consenting to participate
* Scheduled for surgery longer than 2 hours under GA
* Able to read and write

Exclusion Criteria:

* Age\<65
* Refusing to participate
* Existing visual impairment preventing the patient from reading or writing
* Unable to read and write
* Existing major neurocognitive disorder
* Use of TIVA or regional techniques
* Allergies to the volatile agents
* Uncontrolled DM, acute alcohol intoxication
* Conditions increasing tissue oxygen consumption (sepsis, thyrotoxicosis, etc.)
* Anticipation/existence of major hemorrhage
* Haemodynamic instability \> 10 min or more than 5 times intraoperatively

Primary outcomes:
measure: Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 24th hour
timeFrame: Baseline and postoperative day 1
Secondary outcomes:
measure: Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 6th hour
timeFrame: Baseline and postoperative hour 6
measure: Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 3rd day
timeFrame: Baseline and postoperative day 3
measure: Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 7th day
timeFrame: Baseline and postoperative day 7
measure: Change from baseline in pain on the 10 point VAS scale at postoperative 6th hour
timeFrame: Baseline and postoperative hour 6
measure: Change from baseline in pain on the 10 point VAS scale at postoperative 24th hour
timeFrame: Baseline and postoperative hour 24
measure: Change from baseline in pain on the 10 point VAS scale at postoperative 3rd day
timeFrame: Baseline and postoperative day 3
measure: Change from baseline in pain on the 10 point VAS scale at postoperative 7th day
timeFrame: Baseline and postoperative day 7
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Taşcıoğlu City Hospital
Study officials:
affiliation: Prof. Dr. Cemil Taşcıoğlu City Hospital
name: Namigar TURGUT
role: PRINCIPAL_INVESTIGATOR
References: