Postoperative ShiveringNCT06843031
The Role of Perfusion Index in Defining Postoperative Shivering
An observational study of Postoperative Shivering and Perfusion Index, run by Naime Yalçın at 1 site in Turkey (Türkiye).
Trial summary
The relationship between perfusion index and postanesthetic shivering has been investigated in limited studies. Previous studies have investigated the relationship between postanesthetic shivering after total intravenous anesthesia and perfusion index. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Postoperative Shivering, Perfusion Index, General Anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2019to 15 Jun 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study was prepared as a prospective study and submitted to the approval of the Health Sciences University Kanuni Sultan Süleyman E.A.H. Ethics Committee Committee. The study includes adult female patients over the age of 20 who underwent elective gynecological oncology operations under general anesthesia.
Who may be able to join
- over the age of 20,
- in the ASA I-II, III
- who were planned to undergo elective surgery
Who cannot join
- under the age of 20,
- those who did not consent,
- those with mental and/or psychiatric disorders,
- in the ASA IV
- History of allergy to drugs to be used in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Istanbul, 34303
About this study
Official title: Evaluation of Perfusion Index in the Identification of Postoperative Shivering After General Anesthesia, a Prospective Study
The relationship between perfusion index and postanesthetic shivering has been investigated in limited studies. Previous studies have investigated the relationship between postanesthetic shivering after total intravenous anesthesia and perfusion index. The relationship between inhalational anesthesia and postoperative shivering has been investigated, but the role of perfusion index on shivering has also been evaluated in limited studies. Therefore, investigators aimed to investigate whether perianesthetic changes in perfusion index in patients under general anesthesia (inhalation anesthesia and total intravenous anesthesia) correlate with the incidence of postanesthetic shivering and whether they are useful in predicting postanesthetic shivering.
Read the detailed description
Perioperative hypothermia is generally defined as body temperature below 36.0oC. While classified as mild hypothermia (34.C-36.C), moderate hypothermia (32.C-34.C) and severe hypothermia (<32 °C), the most reliable monitoring sites are: pulmonary artery, distal esophagus, nasopharynx and tympanic membrane. measurements. Within approximately 60-90 minutes after anesthesia induction, body temperature decreases with redistribution of the physiological effect of anesthesia. The incidence of perioperative hypothermia in postoperative patients has been reported to be between 20% and 70%. Even mild hypothermia increases the incidence of wound infection, postoperative ischemic myocardial events, and intraoperative blood loss and prolongs the postoperative recovery period. In the hospital environment, the temperature in the extremities is usually 2 to 4°C cooler than the core temperature, and the skin surface is even colder. Body temperature during surgery is affected by a number of anesthesia-related, surgical, environmental, or patient-related risk factors. Surgical risk factors such as surgical technique, duration of surgery, scope of surgery, procedure and amount of irrigation fluid used are at the forefront. In temperature change, behavioral regulation is the strongest thermoregulatory effector. However, patients under anesthesia cannot activate behavioral responses; thermoregulation is only provided by autonomous mechanisms and external thermal management. Vasoconstriction is the most commonly used autonomous effector mechanism in this process. If vasoconstriction is not sufficient and body temperature drops below a certain threshold, shivering begins. Shivering, an involuntary oscillatory pattern of skeletal muscle activity that increases heat production by up to sixfold, is a compensatory mechanism in this sense. It occurs when the temperature of the preoptic area of the hypothalamus decreases. Shivering increases oxygen consumption, causing lactic acidosis, carbon dioxide production, and catecholamine release, eventually increasing cardiac output, heart rate, and arterial pressure. Studies are continuing on the use of perfusion index (PI) for diagnostic purposes regarding the emergence of tremor. Therefore, PI may help reduce the incidence of postoperative shivering with preoperative precautions and preparations. Perfusion index can be calculated using pulse peripheral perfusion oximetry: expressed as the ratio of the pulsatile signal (arterial blood) to the percentage of the non-pulsatile signal (skin, other tissues and non-pulsatile blood), it is a non-invasive measurement, obtained from the amount of infrared light absorbed. PI simultaneously images peripheral perfusion changes during anesthesia, ıt's a very useful monitorization that can help determine the redistribution of body temperature, the effects of vasodilation and their relationship with anesthesia. Previous prospective studies have shown that patients with low PI values before induction of anesthesia are more likely to develop intraoperative hypothermia. It has been found that under general anesthesia, skin temperature contributes almost 20% to the control of vasoconstriction and postanesthetic shivering threshold. In this study, investigator planned to examine whether perioperatif changes in perfusion index are correlated with the incidence of postoperative shivering and therefore whether perfusion index can predict postoperative shivering for preventive purposes under general anesthesia.
- Conditions
- Postoperative Shivering, Perfusion Index, General Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm inhalation anesthesia | Evaluation of peripheral perfusion index during routine monitoring in patients undergoing surgery by gynecologic oncology under desflurane inhalation anesthesia. | |
| Arm total intravenous anesthesia | Evaluation of peripheral perfusion index during routine monitoring in patients undergoing surgery by gynecologic oncology under total intravenous anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
peripheral perfusion index
Measured: From enrollment until the 10th minute after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start15 Jun 2019
- Primary completion15 Jun 2020
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ShiveringStudies 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
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Naime Yalçın
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naime Yalçın, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843031
- Sponsor's protocol ID
- KAEK/2019.05.120
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perfusion Index in the Identification of Postoperative Shivering After General Anesthesia, a Prospective Study
- ClinicalTrials.gov ID
- NCT06843031
- Acronym / sponsor ID
- KAEK/2019.05.120
- Conditions
- Postoperative Shivering, Perfusion Index, General Anesthesia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Naime YalçınUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 24 Feb 2025 (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 relationship between perfusion index and postanesthetic shivering has been investigated in limited studies. Previous studies have investigated the relationship between postanesthetic shivering after total intravenous anesthesia and perfusion index. The relationship between inhalational anesthesia and postoperative shivering has been investigated, but the role of perfusion index on shivering has also been evaluated in limited studies. Therefore, investigators aimed to investigate whether perianesthetic changes in perfusion index in patients under general anesthesia (inhalation anesthesia and total intravenous anesthesia) correlate with the incidence of postanesthetic shivering and whether they are useful in predicting postanesthetic shivering.
Detailed description
Perioperative hypothermia is generally defined as body temperature below 36.0oC. While classified as mild hypothermia (34.C-36.C), moderate hypothermia (32.C-34.C) and severe hypothermia (<32 °C), the most reliable monitoring sites are: pulmonary artery, distal esophagus, nasopharynx and tympanic membrane. measurements. Within approximately 60-90 minutes after anesthesia induction, body temperature decreases with redistribution of the physiological effect of anesthesia. The incidence of perioperative hypothermia in postoperative patients has been reported to be between 20% and 70%. Even mild hypothermia increases the incidence of wound infection, postoperative ischemic myocardial events, and intraoperative blood loss and prolongs the postoperative recovery period. In the hospital environment, the temperature in the extremities is usually 2 to 4°C cooler than the core temperature, and the skin surface is even colder. Body temperature during surgery is affected by a number of anesthesia-related, surgical, environmental, or patient-related risk factors. Surgical risk factors such as surgical technique, duration of surgery, scope of surgery, procedure and amount of irrigation fluid used are at the forefront. In temperature change, behavioral regulation is the strongest thermoregulatory effector. However, patients under anesthesia cannot activate behavioral responses; thermoregulation is only provided by autonomous mechanisms and external thermal management. Vasoconstriction is the most commonly used autonomous effector mechanism in this process. If vasoconstriction is not sufficient and body temperature drops below a certain threshold, shivering begins. Shivering, an involuntary oscillatory pattern of skeletal muscle activity that increases heat production by up to sixfold, is a compensatory mechanism in this sense. It occurs when the temperature of the preoptic area of the hypothalamus decreases. Shivering increases oxygen consumption, causing lactic acidosis, carbon dioxide production, and catecholamine release, eventually increasing cardiac output, heart rate, and arterial pressure. Studies are continuing on the use of perfusion index (PI) for diagnostic purposes regarding the emergence of tremor. Therefore, PI may help reduce the incidence of postoperative shivering with preoperative precautions and preparations. Perfusion index can be calculated using pulse peripheral perfusion oximetry: expressed as the ratio of the pulsatile signal (arterial blood) to the percentage of the non-pulsatile signal (skin, other tissues and non-pulsatile blood), it is a non-invasive measurement, obtained from the amount of infrared light absorbed. PI simultaneously images peripheral perfusion changes during anesthesia, ıt's a very useful monitorization that can help determine the redistribution of body temperature, the effects of vasodilation and their relationship with anesthesia. Previous prospective studies have shown that patients with low PI values before induction of anesthesia are more likely to develop intraoperative hypothermia. It has been found that under general anesthesia, skin temperature contributes almost 20% to the control of vasoconstriction and postanesthetic shivering threshold. In this study, investigator planned to examine whether perioperatif changes in perfusion index are correlated with the incidence of postoperative shivering and therefore whether perfusion index can predict postoperative shivering for preventive purposes under general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm inhalation anesthesia | – | –Evaluation of peripheral perfusion index during routine monitoring in patients undergoing surgery by gynecologic oncology under desflurane inhalation anesthesia. |
| Arm total intravenous anesthesia | – | –Evaluation of peripheral perfusion index during routine monitoring in patients undergoing surgery by gynecologic oncology under total intravenous anesthesia. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was prepared as a prospective study and submitted to the approval of the Health Sciences University Kanuni Sultan Süleyman E.A.H. Ethics Committee Committee. The study includes adult female patients over the age of 20 who underwent elective gynecological oncology operations under general anesthesia.
Key inclusion criteria (3 listed)
- over the age of 20,
- in the ASA I-II, III
- who were planned to undergo elective surgery
Key exclusion criteria (5 listed)
- under the age of 20,
- those who did not consent,
- those with mental and/or psychiatric disorders,
- in the ASA IV
- History of allergy to drugs to be used in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
peripheral perfusion index
Time frame: From enrollment until the 10th minute after extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Shivering and Perfusion Index, run by Naime Yalçın 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peripheral perfusion index (time frame: From enrollment until the 10th minute after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2025.