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Completed

NCT Number: NCT06793150

Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kocaeli University

Kocaeli, 41000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Remifentanil

Drug

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

Other names: ultiva

Dexmedetomidin

Drug

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

Other names: sedadomid

Primary outcomes

  1. cognitive dysfunction

    Time frame: 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 outcomes

  1. comparing anesthesia and opioid free anesthesia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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