Laparoscopic CholecystectomyNCT06022926
Investigation of the Intraoperative and Postoperative Effects of Warming Patients in Laparoscopic Cholecystectomy
A study testing warmed with electric blankets and patients without warming in people with Laparoscopic Cholecystectomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In our study, the investigators will investigate the effects of electric blanket heating on intraoperative hemodynamics, postoperative nausea, vomiting, shivering, agitation and pain in patients undergoing laparoscopic cholecystectomy under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 days to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- warmed with electric blankets and patients without warming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2023to 20 Aug 2024
- Phase
- Interventional
- 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 days to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Laparoscopic cholecystectomy operation will be
- To be between 18-65 years old.
- Being American Society of Anesthesiologists (ASA) Classification I-II.
Who cannot join
- Preoperative body temperature >37.5°C or <36°C.
- Impaired temperature regulation such as systemic infection, mental retardation, isolated head trauma or brain injury.
- Receiving a medication that affects thermoregulation.
- Being American Society of Anesthesiologists (ASA) Classification >III.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, 21070
About this study
Official title: Effects of Patient Warming With Electric Blanket on Intraoperative Hemodynamics; Postoperative Nausea, Vomiting, Chills, Agitation and Pain in Laparoscopic Cholecystectomy Operation
In our study, the investigators will investigate the effects of electric blanket heating on intraoperative hemodynamics, postoperative nausea, vomiting, shivering, agitation and pain in patients undergoing laparoscopic cholecystectomy under general anesthesia.
Read the detailed description
Group 1: Patients warmed with electric blankets
- Patients will be provided with electric blankets from the beginning to the end of the operation (approximately 1 hour)
- all patients will receive standard general anesthesia
- all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.
- each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit.
- mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit.
- the same electric blanket was used for this group of patients
- each time the electric blankets were set to 38 degrees and the blankets were preheated to 38 degrees approximately 30 minutes before the patients were placed on the operating table.
- heat measurements will be made with the same tympanic heat meter device
- heat measurements will be made by a blind anesthesiologist with at least 5 years of experience
- Postoperative evaluations of the patients will be performed face to face.
- patients will be warmed only during the time they are on the operating table
- This study was followed up in the operating room and post-anesthesia recovery unit in the operating room.
Group 2: Control group (patients without warming): no electric blanket will be used, and no heating will be applied to this group of patients.
- all patients will receive standard general anesthesia.
- all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.
- each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit.
- mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit.
- temperature measurements will be performed with the same tympanic thermometer device
- heat measurements will be made by a blind anesthesiologist with at least 5 years of experience
- Postoperative evaluations of the patients will be performed face to face.
- This study was followed up in the operating room and post-anesthesia recovery unit in the operating room.
Statistical methods / analysis: G-Power version 3.1.9.4 (University Kiel, Germany) was used to calculate the sample size. Two-tailed alpha error was 0.05, power as 0.80 and effect size as 0.5, and according to a previous study (Comparison of different end-tidal carbon dioxide levels in preventing postoperative nausea and vomiting in gynaecological patients undergoing laparoscopic surgery. Doi: 10.1080/01443615.2020.1789961.) allocation ratio was accepted as N2/N1:1. The minimum number of patients to be included in the study was calculated as 128.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- warmed with electric blankets, patients without warming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warmed with electric blanketsProcedure or surgery
warmed with electric blankets
patients without warmingOther
patients without warming: no electric blanket will be used, and no heating will be applied to this group of patients.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients warmed with electric blankets | Active comparator | * Patients will be provided with electric blankets from the beginning to the end of the operation (approximately 1 hour)
* all patients will receive standard general anesthesia
* each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit.
* the same electric blanket was used for this group of patients
* each time the electric blankets were set to 38 degrees and the blankets were preheated to 38 degrees approximately 30 minutes before the patients were placed on the operating table.
* heat measurements will be made with the same tympanic heat meter device Receives: Procedure: warmed with electric blankets |
| Group 2: Control group (patients without warming) | Other | * no electric blanket will be used, and no heating will be applied to this group of patients.
* all patients will receive standard general anesthesia
* all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer
* mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit.
* temperature measurements will be performed with the same tympanic thermometer device Receives: Other: patients without warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation assessment
Agitation assessment with Richmond Agitation Sedation Scale (RASS). The Richmond Agitation Sedation Scale (RASS) is a 10-point scale ranging from -5 to +4.Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm.
Measured: Will be assessed from immediately after extubation until transfer from the recovery room to the ward.
Secondary outcomes (6)
Pain assessment
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
post-operative tremor
The evaluation will be made according to this rating:
Grade 1: no tremor Grade 2: mild tremor with mild facial and cervical muscle contraction Grade 3: moderate tremor with obvious tremor of the head and neck, shoulders and/or extremities Grade 4: severe tremor consisting of an obvious tremor all over the body
Measured: Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
Amount of fentanyl consumed intraoperatively
micrograms of fentanyl consumed
Measured: during surgery]
Average blood pressure
Blood pressure will be measured with a non-invasive automatic pneumatic cuff in the operating theatre.
Measured: Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.
Heart rate
the measurement will be obtained by electrocardiographic monitoring
Measured: Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.
nausea-vomiting
-Postoperative nausea and vomiting will be assessed using a 100 mm VAS:
1- severe nausea (VAS>70 mm), 2- moderate nausea (50<VAS<70 mm), 3- mild nausea (VAS <50 mm).
Measured: The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start3 Oct 2023
- Primary completion19 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Cem K. Kaçar, Assoc.Prof, Study director, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022926
- Sponsor's protocol ID
- 11.25.2022/235
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tanaka N, Ohno Y, Hori M, Utada M, Ito K, Suzuki T. A randomised controlled trial of the resistive heating blanket versus the convective warming system for preventing hypothermia during major abdominal surgery. J Perioper Pract. 2013 Apr;23(4):82-6. doi: 10.1177/175045891302300404.
PubMed 23691884Dedeoglu A, Acil F, Andic O, Ozkilic M. Effect of Intraoperative Active Warming Initiated at Anesthesia Induction on Core Temperature, Postoperative Pain and Agitation in Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Medicina (Kaunas). 2026 Jan 15;62(1):175. doi: 10.3390/medicina62010175.
PubMed 41597461
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Patient Warming With Electric Blanket on Intraoperative Hemodynamics; Postoperative Nausea, Vomiting, Chills, Agitation and Pain in Laparoscopic Cholecystectomy Operation
- ClinicalTrials.gov ID
- NCT06022926
- Acronym / sponsor ID
- 11.25.2022/235
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 5 Sep 2023 (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.
In our study, the investigators will investigate the effects of electric blanket heating on intraoperative hemodynamics, postoperative nausea, vomiting, shivering, agitation and pain in patients undergoing laparoscopic cholecystectomy under general anesthesia.
Detailed description
Group 1: Patients warmed with electric blankets
- Patients will be provided with electric blankets from the beginning to the end of the operation (approximately 1 hour)
- all patients will receive standard general anesthesia
- all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.
- each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit.
- mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit.
- the same electric blanket was used for this group of patients
- each time the electric blankets were set to 38 degrees and the blankets were preheated to 38 degrees approximately 30 minutes before the patients were placed on the operating table.
- heat measurements will be made with the same tympanic heat meter device
- heat measurements will be made by a blind anesthesiologist with at least 5 years of experience
- Postoperative evaluations of the patients will be performed face to face.
- patients will be warmed only during the time they are on the operating table
- This study was followed up in the operating room and post-anesthesia recovery unit in the operating room.
Group 2: Control group (patients without warming): no electric blanket will be used, and no heating will be applied to this group of patients.
- all patients will receive standard general anesthesia.
- all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.
- each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit.
- mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit.
- temperature measurements will be performed with the same tympanic thermometer device
- heat measurements will be made by a blind anesthesiologist with at least 5 years of experience
- Postoperative evaluations of the patients will be performed face to face.
- This study was followed up in the operating room and post-anesthesia recovery unit in the operating room.
Statistical methods / analysis: G-Power version 3.1.9.4 (University Kiel, Germany) was used to calculate the sample size. Two-tailed alpha error was 0.05, power as 0.80 and effect size as 0.5, and according to a previous study (Comparison of different end-tidal carbon dioxide levels in preventing postoperative nausea and vomiting in gynaecological patients undergoing laparoscopic surgery. Doi: 10.1080/01443615.2020.1789961.) allocation ratio was accepted as N2/N1:1. The minimum number of patients to be included in the study was calculated as 128.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients warmed with electric blankets | Active comparator | Procedure: warmed with electric blankets* Patients will be provided with electric blankets from the beginning to the end of the operation (approximately 1 hour) * all patients will receive standard general anesthesia * each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit. * the same electric blanket was used for this group of patients * each time the electric blankets were set to 38 degrees and the blankets were preheated to 38 degrees approximately 30 minutes before the patients were placed on the operating table. * heat measurements will be made with the same tympanic heat meter device |
| Group 2: Control group (patients without warming) | Other | Other: patients without warming* no electric blanket will be used, and no heating will be applied to this group of patients. * all patients will receive standard general anesthesia * all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer * mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit. * temperature measurements will be performed with the same tympanic thermometer device |
Who may qualify
- Ages
- 18 days to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Laparoscopic cholecystectomy operation will be
- To be between 18-65 years old.
- Being American Society of Anesthesiologists (ASA) Classification I-II.
Key exclusion criteria (4 listed)
- Preoperative body temperature >37.5°C or <36°C.
- Impaired temperature regulation such as systemic infection, mental retardation, isolated head trauma or brain injury.
- Receiving a medication that affects thermoregulation.
- Being American Society of Anesthesiologists (ASA) Classification >III.
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 |
|---|---|---|
| warmed with electric blanketswarmed with electric blankets | Procedure or surgery | Group 1: Patients warmed with electric blankets |
| patients without warmingpatients without warming: no electric blanket will be used, and no heating will be applied to this group of patients. | Other | Group 2: Control group (patients without warming) |
Primary outcome
Agitation assessment
Time frame: Will be assessed from immediately after extubation until transfer from the recovery room to the ward.
Agitation assessment with Richmond Agitation Sedation Scale (RASS). The Richmond Agitation Sedation Scale (RASS) is a 10-point scale ranging from -5 to +4.Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm.
6 secondary outcomes
Pain assessment
Time frame: Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
post-operative tremor
Time frame: Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
Amount of fentanyl consumed intraoperatively
Time frame: during surgery]
Average blood pressure
Time frame: Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.
Heart rate
Time frame: Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.
nausea-vomiting
Time frame: The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 23691884Tanaka N, Ohno Y, Hori M, Utada M, Ito K, Suzuki T. A randomised controlled trial of the resistive heating blanket versus the convective warming system for preventing hypothermia during major abdominal surgery. J Perioper Pract. 2013 Apr;23(4):82-6. doi: 10.1177/175045891302300404.
- Derived from this study: PubMed 41597461Dedeoglu A, Acil F, Andic O, Ozkilic M. Effect of Intraoperative Active Warming Initiated at Anesthesia Induction on Core Temperature, Postoperative Pain and Agitation in Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Medicina (Kaunas). 2026 Jan 15;62(1):175. doi: 10.3390/medicina62010175.
- Individual participant dataSharing planned: Undecided
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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.
Cem K. Kaçar, Assoc.Prof study director
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warmed with electric blankets and patients without warming in people with Laparoscopic Cholecystectomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 21 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Agitation assessment (time frame: Will be assessed from immediately after extubation until transfer from the recovery room to the ward.). 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 NCT06022926, which also lists 2 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 21 Aug 2024.