Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries

NCT06793150 | Completed Phase 4

• 1 other identifier: AIBU-AR-GÇÖ-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the patients undergoing pituitary surgery in our clinic have examined in two groups. In the first group, anesthesia maintenance was provided with remifentanil and propofol infusion. In the second group, anesthesia maintenance was provided with dexmedetomidine and propofol infusion. Demographic data, vital signs during the operation, wake-up time, extubation time, and drug consumption amounts were recorded. The mini-mental test was applied preoperatively, 24 hours postoperatively, and 3 weeks postoperatively to examine whether there is a difference in cognitive dysfunction between the two groups.

Conditions

Cognitive Dysfunction; Opioid Free Anesthesia

Outcome Measures

Primary Outcomes (1)

• cognitive dysfunction

  Our primary objective is comparing postoperative cognitive dysfunction using the Mini-Mental State Examination after anesthesia 24 hours and 3 weeks after surgery

  preoperative, postoperative 24th hour and 3rd week

Secondary Outcomes (1)

• comparing anesthesia and opioid free anesthesia

  preoperative, postoperative 24th hour and 3rd week

Study Arms (2)

group d

ACTIVE COMPARATOR

group d anesthesia maintaiance with dexmedetomidine

Drug: dexmedetomidin

group r

ACTIVE COMPARATOR

group r anesthesia maintainence with remifentanile

Drug: Remifentanil

Interventions

Remifentanil DRUG

A comparison will be made by maintaining one group with remifentanil and the other with dexmedetomidine.

Also known as: ultiva

group r

dexmedetomidin DRUG

A comparison will be made by maintaining one group with remifentanil and the other with dexmedetomidine.

Also known as: sedadomid

group d

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing transsphenoidal pituitary elective surgery
• Patients classified as ASA (American Society of Anesthesiologists) physical status classification I-III
• Patients aged between 18 and 65 years

You may not qualify if:

• Patients scheduled for emergency surgery
• Patients classified as ASA (American Society of Anesthesiologists) physical status classification IV-V
• Patients with psychiatric disorders
• Patients with a history of stroke, dementia, electrolyte disturbances, or serious liver and/or kidney disease
• Patients with a history of substance abuse"

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41000, Turkey (Türkiye)

Location

Related Publications (3)

• Lin X, Chen Y, Zhang P, Chen G, Zhou Y, Yu X. The potential mechanism of postoperative cognitive dysfunction in older people. Exp Gerontol. 2020 Feb;130:110791. doi: 10.1016/j.exger.2019.110791. Epub 2019 Nov 23.

  PMID: 31765741 BACKGROUND

• Kotekar N, Shenkar A, Nagaraj R. Postoperative cognitive dysfunction - current preventive strategies. Clin Interv Aging. 2018 Nov 8;13:2267-2273. doi: 10.2147/CIA.S133896. eCollection 2018.

  PMID: 30519008 BACKGROUND

• Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.

  PMID: 32530891 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Remifentanil; Dexmedetomidine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: group d maintaiance with dexmedetomidine group r maintainence with remifentanile
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: group d maintaiance with dexmedetomidine group r maintainence with remifentanile

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: January 27, 2025
• Study Start: September 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: March 31, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)