Investigation of the Intraoperative and Postoperative Effects of Warming Patients in Laparoscopic Cholecystectomy

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the lead sponsor of 56 studies on the registry; 25 are open to participants now.

Study arms

• Active comparator
  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 * 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

  Procedure: warmed with electric blankets

• Other
  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 * 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

  Other: patients without warming

Interventions

• Procedurewarmed with electric blankets

  warmed with electric blankets

• Otherpatients without warming

  patients without warming: no electric blanket will be used, and no heating will be applied to this group of patients.

Primary outcomes

1. 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.

   Time frame: Will be assessed from immediately after extubation until transfer from the recovery room to the ward.

Secondary outcomes

1. 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."

   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.

2. 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

   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.

3. Amount of fentanyl consumed intraoperatively

   micrograms of fentanyl consumed

   Time frame: during surgery]

4. Average blood pressure

   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.

5. Heart rate

   the measurement will be obtained by electrocardiographic monitoring

   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.

6. 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).

   Time frame: The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.

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 23691884 ↗

Individual participant data

Plan to share: Undecided