An observational study in Hypothermia; Anesthesia, Agitation, Emergence and Postoperative Complications, sponsored by Kocaeli City Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Kocaeli City Hospital · Observational
The main aim of our study was to investigate the relationship between perioperative hypothermia and postoperative emergence agitation.
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.
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's planned enrollment of 120 is above the median of 95 across 106 observational studies indexed under Hypothermia.
Browse Hypothermia studies →Kocaeli City Hospital is the lead sponsor of 44 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who will be operated in ENT operating rooms in a tertiary education and research hospital
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who developed postoperative hypothermia were included in this group.
Procedure: surgery · Procedure: sedation scale
Patients who did not develop postoperative hypothermia were included in this group.
Procedure: surgery · Procedure: sedation scale
ENT surgery lasting more than half an hour
Measurement of postoperative recovery with the Richmond agitation scale and the Riker sedation scale
Relationship between hypothermia and emergence agitation
Comparison of recovery agitation rates in postoperative hypothermic and non-hypothermic patients
Time frame: first postoperative hour
Incidence of perioperative hypothermia
Incidence of hypothermia observed in the operating room and recovery room
Time frame: Between the first 1 hour preoperatively and the first 1 hour postoperatively
Comparison of agitation/sedation rates in hypothermic patients
Comparison of agitation/sedation rates in hypothermic patients will be compared by measuring percentages
Time frame: Between the first 1 hour preoperatively and the first 1 hour postoperatively
Plan to share: No — Patient data can be obtained from the health directorate with appropriate permission and request. Data collected for research will not be shared.
Started Mar 2024 (actual). Primary completion is estimated for Aug 2024, 5 months after the start.
Of 47 non-industry observational studies under Hypothermia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 50. This study's planned 5 months is below that.
Counting every sponsor, half of 48 studies reached it within 12 months; a quarter within 4 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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Kocaeli City Hospital