Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries

Phase 4

Completed

• Conditions: Cognitive Dysfunction; Opioid Free Anesthesia
• Interventions: Drug: dexmedetomidin; Drug: Remifentanil

• Registration Number: NCT06793150
• Lead Sponsor: Kocaeli University

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.

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-03-31
• Study First Submitted: 2024-07-16
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-18
• Last Update Submitted: 2025-01-18
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group d	dexmedetomidin	group d anesthesia maintaiance with dexmedetomidine
group r	Remifentanil	group r anesthesia maintainence with remifentanile

Primary Outcome Measures

Name	Time	Method
cognitive dysfunction	preoperative, postoperative 24th hour and 3rd week	Our primary objective is comparing postoperative cognitive dysfunction using the Mini-Mental State Examination after anesthesia 24 hours and 3 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
comparing anesthesia and opioid free anesthesia	preoperative, postoperative 24th hour and 3rd week	Our secondary objective is to compare the times of eye opening and extubation after opioid free anesthesia and anesthesia with opioid.

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey