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Recruiting NCT06543134

Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation

Observational Hypothermia; Anesthesia Agitation, Emergence Postoperative Complications Hypothermia Following Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: surgery, sedation scale.
Who it may be relevant to
Registry conditions: Hypothermia; Anesthesia, Agitation, Emergence, Postoperative Complications, Hypothermia Following Anesthesia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Detailed description

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.

Interventions

  • Procedure surgery
    ENT surgery lasting more than half an hour
  • Procedure sedation scale
    Measurement of postoperative recovery with the Richmond agitation scale and the Riker sedation scale

Primary outcome measures

  • Relationship between hypothermia and emergence agitation [Time frame: first postoperative hour]
Secondary outcome measures (1)
  • Incidence of perioperative hypothermia [Time frame: Between the first 1 hour preoperatively and the first 1 hour postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Kocaeli City Hospital — Kocaeli

Publications

  • Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5. PMID 20526708
  • Demir CY, Yuzkat N. Prevention of Emergence Agitation with Ketamine in Rhinoplasty. Aesthetic Plast Surg. 2018 Jun;42(3):847-853. doi: 10.1007/s00266-018-1103-4. Epub 2018 Feb 20. PMID 29464385
  • Chen L, Xu M, Li GY, Cai WX, Zhou JX. Incidence, Risk Factors and Consequences of Emergence Agitation in Adult Patients after Elective Craniotomy for Brain Tumor: A Prospective Cohort Study. PLoS One. 2014 Dec 10;9(12):e114239. doi: 10.1371/journal.pone.0114239. eCollection 2014. PMID 25493435
  • Lee SJ, Sung TY. Emergence agitation: current knowledge and unresolved questions. Korean J Anesthesiol. 2020 Dec;73(6):471-485. doi: 10.4097/kja.20097. Epub 2020 Mar 25. PMID 32209961

Identifiers

NCT: NCT06543134 · ACicek

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗