Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, 21070, Turkey (Türkiye)
NCT Number: NCT06022926
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.
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Notify Me18 day–65 year
All sexes
Interventional
Not applicable
Diyarbakır, 21070, Turkey (Türkiye)
Group 1: Patients warmed with electric blankets
Group 2: Control group (patients without warming): no electric blanket will be used, and no heating will be applied to this group of patients.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
warmed with electric blankets
patients without warming: no electric blanket will be used, and no heating will be applied to this group of patients.
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.
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.
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."
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.
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
Time frame: during surgery]
micrograms of fentanyl consumed
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.
Blood pressure will be measured with a non-invasive automatic pneumatic cuff in the operating theatre.
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.
the measurement will be obtained by electrocardiographic monitoring
Time frame: The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.
-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).
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Other
Effects of Patient Warming With Electric Blanket on Intraoperative Hemodynamics; Postoperative Nausea, Vomiting, Chills, Agitation and Pain in Laparoscopic Cholecystectomy Operation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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