Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06543134

Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation

The main aim of our study was to investigate the relationship between perioperative hypothermia and postoperative emergence agitation.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ahmet Yüksek, md

SUB_INVESTIGATOR

Aleyna Çiçek, md

PRINCIPAL_INVESTIGATOR

Mehmet Yilmaz, md

SUB_INVESTIGATOR

Mehmet Yılmaz, MD

CONTACT

[email protected]

05052174432

About this study

Unintentional hypothermia during surgery is defined as a decrease in body temperature below 36.0 C in the preoperative period, 1 hour before anesthesia and within the first 24 hours after surgery (1).

Unintentional hypothermia during surgery is seen in most patients undergoing surgery. The incidence of perioperative hypothermia is expressed with different values in different studies, but it varies between 30% and 90% (2,3). Hypothermia has many negative effects on mortality and morbidity, such as increased hospital stay, increased perioperative bleeding, increased cardiac complications, delayed wound healing, and delayed recovery from anesthesia (4). It has been observed that these negative effects are seen even in mild hypothermia and that patients should take a more active role in preventing perioperative hypothermia (5). Risk factors for perioperative hypothermia include many factors such as prolonged surgery, advanced age, ASA score, gender, and intravenous fluid administration.

The mentioned negative situation is a negative situation. Recovery agitation was first described in the 1960s and is characterized by restlessness, crying, and poor cooperation (6). Recovery agitation may be severe in the first 30 minutes and then subside. During this time, it may lead to self-harm, disruption of surgical drains or dressings, increased bleeding and surgical complications, unintended early extubations, and an increase in falls and other similar complications in patients (7). Recovery agitation in pediatric patients is measured by the Pediatric Anesthesia Early Delirium Scale and in adult patients, usually by the Richmond Agitation Sedation Scale (8). The incidence of recovery agitation is approximately 20%, and its pathophysiology is not yet fully understood. Risk factors include age, gender, ASA physical status, type of surgery, anesthetic technique (inhalation or total intravenous), administration of neostigmine or doxapram, inadequate postoperative analgesia, pain, presence of a tracheal tube, and presence of a urinary catheter (9). In our literature review, we observed that the effects of perioperative hypothermia and core temperature changes on recovery agitation have not been sufficiently investigated. In this study, we aimed to investigate the relationship between perioperative hypothermia and recovery agitation in patients undergoing septoplasty/rhinoplasty, functional endoscopic sinus surgery (FESS), tympanoplasty, and mastoidectomy in otolaryngology operating rooms.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with informed consent Elective planned cases
  • Patients between the ages of 18-65
  • American Society of Anesthesiologists ASA classification ASA 1-2 patients
  • Surgeries planned to last at least 30 minutes.

Exclusion criteria

  • Patients who refuse to participate in the study,
  • patients who are considered for emergency surgery,
  • pediatric patients,
  • patients with peripheral vascular diseases or carotid stenosis,
  • patients using antidepressants or antipsychotic drugs
  • those with neurological diseases will be excluded from the study.

Treatment and study plan

Surgery

Procedure

ENT surgery lasting more than half an hour

sedation scale

Procedure

Measurement of postoperative recovery with the Richmond agitation scale and the Riker sedation scale

Primary outcomes

  1. Relationship between hypothermia and emergence agitation

    Time frame: first postoperative hour

    Comparison of recovery agitation rates in postoperative hypothermic and non-hypothermic patients

Secondary outcomes

  1. Incidence of perioperative hypothermia

    Time frame: Between the first 1 hour preoperatively and the first 1 hour postoperatively

    Incidence of hypothermia observed in the operating room and recovery room

Other outcomes

  1. Comparison of agitation/sedation rates in hypothermic patients

    Time frame: Between the first 1 hour preoperatively and the first 1 hour postoperatively

    Comparison of agitation/sedation rates in hypothermic patients will be compared by measuring percentages

Study contacts

Contact information is provided by the study sponsor or research team.

Aleyna Çiçek, md

CONTACT

[email protected]

05396148709

Sponsors and collaborators

Lead sponsor

Kocaeli City Hospital

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

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.

Published trials that share one or more normalized conditions with this study.