ClinicalTrials.Veeva

Menu

Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries

K

Kocaeli University

Status and phase

Completed
Phase 4

Conditions

Cognitive Dysfunction
Opioid Free Anesthesia

Treatments

Drug: Remifentanil
Drug: dexmedetomidin

Study type

Interventional

Funder types

Other

Identifiers

NCT06793150
AIBU-AR-GÇÖ-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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"

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

group d
Active Comparator group
Description:
group d anesthesia maintaiance with dexmedetomidine
Treatment:
Drug: dexmedetomidin
group r
Active Comparator group
Description:
group r anesthesia maintainence with remifentanile
Treatment:
Drug: Remifentanil

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems