Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation

NCT06543134 | Recruiting

• 1 other identifier: ACicek
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Hypothermia; Agitation; Emergence; Recovery from anesthesia; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Relationship between hypothermia and emergence agitation

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

  first postoperative hour

Secondary Outcomes (1)

• Incidence of perioperative hypothermia

  Between the first 1 hour preoperatively and the first 1 hour postoperatively

Other Outcomes (1)

• Comparison of agitation/sedation rates in hypothermic patients

  Between the first 1 hour preoperatively and the first 1 hour postoperatively

Study Arms (2)

Group A

Patients who developed postoperative hypothermia were included in this group.

Procedure: surgery; Procedure: sedation scale

Group B

Patients who did not develop postoperative hypothermia were included in this group.

Procedure: surgery; Procedure: sedation scale

Interventions

surgery PROCEDURE

ENT surgery lasting more than half an hour

Group A; Group B

sedation scale PROCEDURE

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hypothermia; Emergence Delirium; Postoperative Complications; Psychomotor Agitation

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Aleyna Çiçek, md

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleyna Çiçek, md

CONTACT

05396148709; aleynacicek_61@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 7, 2024
• Study Start: March 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: September 15, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)