Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries

NCT ID: NCT06793150

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-03-31

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.

Detailed Description

Postoperative cognitive dysfunction refers to disorders affecting orientation, attention, perception, consciousness, and judgment that develop after surgery. It is a common postoperative complication and a serious threat to the quality of life, particularly for elderly patients. Strategies to prevent surgery and anesthesia-induced cognitive dysfunction are being investigated, considering the choice and depth of anesthesia, perioperative anesthetic and other drugs, and surgical strategy.

Opioid-free anesthesia involves the administration of intraoperative anesthesia without the use of intraoperative opioids. Currently available non-opioid drugs include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) (ketorolac, ibuprofen, celecoxib), alpha-2 agonists (dexmedetomidine, clonidine, tizanidine), and N-methyl-D-aspartate (NMDA) receptor antagonists (ketamine). Dexmedetomidine (DEX) is an alpha-2 adrenoceptor agonist with a selectivity ratio of 1600:1 (α2:α1). It promotes sedation by acting on the α2 receptors of the locus coeruleus and produces analgesia by reducing the release of substance P in the spinal cord dorsal horn.

The goals of opioid use during anesthesia are to reduce the need for hypnotic agents and provide effective analgesia. However, the potential side effects of opioids can be described as having a threefold negative impact, ranging from sudden adverse reactions in the patient to the long-term sequelae of chronic effects.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

group d

group d anesthesia maintaiance with dexmedetomidine

Group Type: ACTIVE_COMPARATOR

dexmedetomidin

Intervention Type: DRUG

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

group r

group r anesthesia maintainence with remifentanile

Group Type: ACTIVE_COMPARATOR

Remifentanil

Intervention Type: DRUG

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

Interventions

Remifentanil

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

Intervention Type: DRUG

dexmedetomidin

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

Intervention Type: DRUG

Other Intervention Names

ultiva; sedadomid

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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"

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Gökçe Çile Özer

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kocaeli University

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 31765741 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30519008 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 32530891 (View on PubMed)

Other Identifiers

AIBU-AR-GÇÖ-01

Identifier Type: -

Identifier Source: org_study_id