Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06543134

Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation in Adults Undergoing ENT Surgery

Led by Kocaeli City Hospital · Updated on 2024-08-07

120

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the link between unintentional low body temperature during surgery, known as perioperative hypothermia, and agitation that can occur as patients wake up from anesthesia. This observation study focuses on adults aged 18 to 65 undergoing specific ear, nose, and throat surgeries lasting at least 30 minutes. Hypothermia during surgery is common and can lead to complications such as increased bleeding, delayed healing, and longer hospital stays. Emergence agitation, characterized by restlessness and poor cooperation during recovery, is also a concern but its connection to hypothermia is not well understood. Participants will be observed during their planned surgeries, which include septoplasty, rhinoplasty, functional endoscopic sinus surgery, tympanoplasty, and mastoidectomy. The study groups are divided based on whether they develop hypothermia after surgery or not. Recovery will be assessed using tools like the Richmond Agitation Sedation Scale and the Riker Sedation Scale during the first hour after surgery to monitor agitation levels. During the study, patients' temperatures will be monitored from one hour before anesthesia to one hour after surgery to track hypothermia occurrence. Researchers will evaluate the relationship between low body temperature and emergence agitation within the first postoperative hour. The study also records how often hypothermia occurs during this time. Participation involves routine surgical and recovery assessments with no additional treatments, and the total involvement includes the surgery and immediate postoperative monitoring.

CONDITIONS

Brief Title

Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with informed consent for elective planned surgeries
  • Aged between 18 and 65 years
  • American Society of Anesthesiologists (ASA) classification of 1 or 2
  • Surgeries planned to last at least 30 minutes
Not Eligible

You will not qualify if you...

  • Patients who refuse to participate
  • Patients scheduled for emergency surgery
  • Pediatric patients
  • Patients with peripheral vascular disease or carotid artery narrowing
  • Patients using antidepressant or antipsychotic drugs
  • Patients with neurological diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and first postoperative hour

Participants undergo ENT surgery lasting more than half an hour and are monitored for perioperative hypothermia and emergence agitation during the first hour after surgery.

1 visit (in-person)

Post-operative Follow-up

Duration - First postoperative hour

Participants are observed for recovery agitation using sedation scales during the immediate post-operative period.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye), 41100

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Research Team

A

Aleyna Çiçek, md

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Incidence, Risk Factors and Consequences of Emergence Agitation in Adult Patients after Elective Craniotomy for Brain Tumor: A Prospective Cohort Study.

Lu Chen, Ming Xu, Gui-Yun Li...

https://pubmed.ncbi.nlm.nih.gov/25493435