Hypothermia; AnesthesiaNCT06543134
Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation
An observational study of Hypothermia; Anesthesia and Agitation, Emergence, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The main aim of our study was to investigate the relationship between perioperative hypothermia and postoperative emergence agitation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia; Anesthesia, Agitation, Emergence, Postoperative Complications
- What is being tested?
- surgery and sedation scale
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 15 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who will be operated in ENT operating rooms in a tertiary education and research hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli City Hospital
Kocaeli, Izmit, 41100
Mehmet Yılmaz, MD, 05052174432, drmyilmaz33@gmail.com
Aleyna Çiçek, md
About this study
The main aim of our study was to investigate the relationship between perioperative hypothermia and postoperative emergence agitation.
Read the 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.
- Conditions
- Hypothermia; Anesthesia, Agitation, Emergence, Postoperative Complications, Hypothermia Following Anesthesia
- Being tested
- surgery, sedation scale
- Keywords
- Hypothermia, Agitation, Emergence, Recovery from anesthesia, Postoperative Complications
- Medical subject headings
- Hypothermia, Emergence Delirium, Postoperative Complications, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
ENT surgery lasting more than half an hour
sedation scaleProcedure or surgery
Measurement of postoperative recovery with the Richmond agitation scale and the Riker sedation scale
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients who developed postoperative hypothermia were included in this group. Receives: Procedure: surgery; Procedure: sedation scale | |
| Group B | Patients who did not develop postoperative hypothermia were included in this group. Receives: Procedure: surgery; Procedure: sedation scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between hypothermia and emergence agitation
Comparison of recovery agitation rates in postoperative hypothermic and non-hypothermic patients
Measured: first postoperative hour
Secondary outcomes (1)
Incidence of perioperative hypothermia
Incidence of hypothermia observed in the operating room and recovery room
Measured: Between the first 1 hour preoperatively and the first 1 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Mar 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypothermia; AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aleyna Cicek, Kocaeli City Hospital
- Investigators
- Aleyna Çiçek, md, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543134
- Sponsor's protocol ID
- ACicek
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data can be obtained from the health directorate with appropriate permission and request. Data collected for research will not be shared.
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.
PubMed 20526708Demir 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.
PubMed 29464385Chen 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.
PubMed 25493435Lee 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.
PubMed 32209961
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation
- ClinicalTrials.gov ID
- NCT06543134
- Acronym / sponsor ID
- ACicek
- Conditions
- Hypothermia; Anesthesia, Agitation, Emergence, Postoperative Complications, Hypothermia Following Anesthesia
- Keywords
- Hypothermia, Agitation, Emergence, Recovery from anesthesia, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: surgery, Procedure: sedation scalePatients who developed postoperative hypothermia were included in this group. |
| Group B | – | Procedure: surgery, Procedure: sedation scalePatients who did not develop postoperative hypothermia were included in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be operated in ENT operating rooms in a tertiary education and research hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryENT surgery lasting more than half an hour | Procedure or surgery | Group A, Group B |
| sedation scaleMeasurement of postoperative recovery with the Richmond agitation scale and the Riker sedation scale | Procedure or surgery | Group A, Group B |
Primary outcome
Relationship between hypothermia and emergence agitation
Time frame: first postoperative hour
Comparison of recovery agitation rates in postoperative hypothermic and non-hypothermic patients
1 secondary outcome
Incidence of perioperative hypothermia
Time frame: Between the first 1 hour preoperatively and the first 1 hour postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 20526708Yu 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.
- Background: PubMed 29464385Demir 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.
- Background: PubMed 25493435Chen 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.
- Background: PubMed 32209961Lee 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.
- Individual participant dataSharing planned: No. Patient data can be obtained from the health directorate with appropriate permission and request. Data collected for research will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleyna Çiçek, md principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia; Anesthesia and Agitation, Emergence, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleyna Çiçek, md (05396148709, aleynacicek_61@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between hypothermia and emergence agitation (time frame: first postoperative hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06543134, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.