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Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries

Comparison of the Effects of Opioid-Based Anesthesia Versus Opioid-Free Anesthesia on Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06793150
Enrollment
48
Registered
2025-01-27
Start date
2023-09-01
Completion date
2024-03-31
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Opioid Free Anesthesia

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.

Interventions

DRUGRemifentanil

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

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

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

group d maintaiance with dexmedetomidine group r maintainence with remifentanile

Intervention model description

group d maintaiance with dexmedetomidine group r maintainence with remifentanile

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cognitive dysfunctionpreoperative, postoperative 24th hour and 3rd weekOur primary objective is comparing postoperative cognitive dysfunction using the Mini-Mental State Examination after anesthesia 24 hours and 3 weeks after surgery

Secondary

MeasureTime frameDescription
comparing anesthesia and opioid free anesthesiapreoperative, postoperative 24th hour and 3rd weekOur secondary objective is to compare the times of eye opening and extubation after opioid free anesthesia and anesthesia with opioid.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026