Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation

NCT ID: NCT06543134

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-09-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypothermia; Anesthesia Agitation, Emergence Postoperative Complications Hypothermia Following Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Patients who developed postoperative hypothermia were included in this group.

surgery

Intervention Type PROCEDURE

ENT surgery lasting more than half an hour

sedation scale

Intervention Type PROCEDURE

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.

surgery

Intervention Type PROCEDURE

ENT surgery lasting more than half an hour

sedation scale

Intervention Type PROCEDURE

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

Interventions

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surgery

ENT surgery lasting more than half an hour

Intervention Type PROCEDURE

sedation scale

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kocaeli City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Aleyna Cicek

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aleyna Çiçek, md

Role: PRINCIPAL_INVESTIGATOR

Kocaeli City Hospital

Locations

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Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Aleyna Çiçek, md

Role: CONTACT

05396148709

Facility Contacts

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Mehmet Yılmaz, MD

Role: primary

05052174432

References

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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.

Reference Type BACKGROUND
PMID: 20526708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29464385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25493435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32209961 (View on PubMed)

Other Identifiers

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ACicek

Identifier Type: -

Identifier Source: org_study_id

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