Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation

August 3, 2024 updated by: Aleyna Cicek, Kocaeli City Hospital
The main aim of our study was to investigate the relationship between perioperative hypothermia and postoperative emergence agitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Izmit
      • Kocaeli, Izmit, Turkey, 41100
        • Recruiting
        • Kocaeli City Hospital
        • Sub-Investigator:
          • Mehmet Yilmaz, md
        • Contact:
        • Principal Investigator:
          • Aleyna Çiçek, md
        • Sub-Investigator:
          • Ahmet Yüksek, md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who will be operated in ENT operating rooms in a tertiary education and research hospital

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Patients who developed postoperative hypothermia were included in this group.
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
Group B
Patients who did not develop postoperative hypothermia were included in this group.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between hypothermia and emergence agitation
Time Frame: first postoperative hour
Comparison of recovery agitation rates in postoperative hypothermic and non-hypothermic patients
first postoperative hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Between the first 1 hour preoperatively and the first 1 hour postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Between the first 1 hour preoperatively and the first 1 hour postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli City Hospital

Investigators

  • Principal Investigator: Aleyna Çiçek, md, Kocaeli City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 3, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACicek

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient data can be obtained from the health directorate with appropriate permission and request. Data collected for research will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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