Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06022926
Other study ID # 11.25.2022/235
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 3, 2023
Est. completion date May 20, 2024

Study information

Verified date April 2024
Source Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Contact Fatma Acil, M.D.
Phone +905337225225
Email acilfatma@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 128
Est. completion date May 20, 2024
Est. primary completion date May 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Days to 65 Years
Eligibility Inclusion Criteria: - Laparoscopic cholecystectomy operation will be - To be between 18-65 years old. - Being American Society of Anesthesiologists (ASA) Classification I-II. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
warmed with electric blankets
warmed with electric blankets
Other:
patients without warming
patients without warming: no electric blanket will be used, and no heating will be applied to this group of patients.

Locations

Country Name City State
Turkey Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital Diyarbakir

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Will be assessed from immediately after extubation until transfer from the recovery room to the ward.
Secondary 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." Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
Secondary 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
Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
Secondary Amount of fentanyl consumed intraoperatively micrograms of fentanyl consumed during surgery]
Secondary Average blood pressure Blood pressure will be measured with a non-invasive automatic pneumatic cuff in the operating theatre. 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.
Secondary Heart rate the measurement will be obtained by electrocardiographic monitoring 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.
Secondary nausea-vomiting -Postoperative nausea and vomiting will be assessed using a 100 mm VAS:
1- severe nausea (VAS>70 mm), 2- moderate nausea (50
The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.
See also
  Status Clinical Trial Phase
Completed NCT03670849 - Image Fusion in the OR N/A
Withdrawn NCT04561583 - Effectiveness and Safety of LED Light Source System for Endoscope N/A
Completed NCT00872287 - Pain in Single Incision Laparoscopic Surgery Cholecystectomy Phase 4
Recruiting NCT06017167 - Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy Phase 2
Completed NCT05536557 - Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy. N/A
Recruiting NCT05794503 - Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex Early Phase 1
Completed NCT05998317 - Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy Phase 2/Phase 3
Completed NCT04759079 - The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy N/A
Recruiting NCT04138472 - Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy N/A
Completed NCT02469831 - Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy Phase 2
Completed NCT03067038 - Single Incision Versus Three Port Laparoscopic Cholecystectomy N/A
Completed NCT00886210 - Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy N/A
Completed NCT00292214 - Comparing Intravenous and Oral Paracetamol for Cholecystectomy Phase 4
Recruiting NCT05533567 - Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol N/A
Recruiting NCT05533580 - Differential Effects of Remimazolam and Propofol on Dynamic Cerebral Autoregulation During General Anesthesia N/A
Active, not recruiting NCT05636475 - The Effect Of Machine-Based And Manually Applied Hand Massage On Pain, Anxiety And Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery N/A
Recruiting NCT05094193 - Trocar-site Infiltration Versus TAP-block N/A
Completed NCT03323684 - Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia N/A
Recruiting NCT04162106 - Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS N/A
Unknown status NCT01041183 - The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy N/A