Opioid free anesthesia is an anesthetic technique, in which administration of multimodal analgesia and sympathicolytics provides hemodynamic stability without use of opioids. Such management may be beneficial to the obese patients undergoing laparoscopic sleeve gastrectomy. Our study aims to compare opioid free anesthesia in such patients with standard, short-acting opioid based.
The study has been approved by Bioethical Committee of Medical University of Warsaw. Informed written consent will be obtained from all patients. Sample size of 60 patients has been calculated based on the Altman normogram to obtain 30% reduction of postoperative opioid consumption with significance and power of 90%. Consenting patients scheduled for laparoscopic sleeve gastrectomy will be randomly assigned to the computer generated list to receive opioid free or standard opioid based anesthesia. Opioid free protocol includes administration of dexmedetomidine, lidocaine, ketamine, magnesium sulphate whereas standard group will receive remifentanil TCI Minto Model. After the end of operation all of the patient will receive oxycodone and additional doses via PCA system for postoperative analgesia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
59
Initial dosis of dexmedetomidine 1 mcg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 1 mcg/kg IBW / h will be initiated and continued until the end of operation.
Remifentanil TCI Minto Model will be used during induction in dosis 6 ng/ml and intraoperatively appropriately to maintain hemodynamical stability.
Ketamine 0,5mg/kg IBW iv will be administered during induction of general anesthesia.
Szpital Kliniczny Dzieciatka Jezus
Warsaw, Poland
Total postoperative oxycodone consumption
PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes
Time frame: Day "0"
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Time frame: Day "0", assessed 1 hour after operation
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Time frame: Day "0", assessed 6 hours after operation
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Time frame: Day "0", assessed 12 hours after operation
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Time frame: Day "1" assessed 24 hours after operation
Postoperative sedation score
1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Postoperative nausea and vomiting
Simplified PONV impact scale 0-6 0 - no nausea nor vomiting 6 - \>3 episodes of vomiting and nausea all of the time
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Rescue fentanyl administration dosis
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Initial dosis of lidocaine 1,5 mg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 3 mg/kg IBW / h will be initiated and continued until the end of operation.
Magnesium Sulphate will be administered in dosis 50 mg/kg IBW iv intraoperatively.
Rescue dosis of 100 mcg iv will be administered if hypertension \> 140/90 mmHg or tachycardia \> 120min occurs. If necessary rescue dosis may be repeated.
In opioid free group, rescue fentanyl dosis will be administered if hypertension \> 140/90 mmHg or tachycardia \> 120/min occurs
Time frame: intraoperative
Highest BP
Highest BP during operation
Time frame: intraoperative
Lowest BP
Lowest BP during operation
Time frame: intraoperative
Highest HR
Highest HR during operation
Time frame: intraoperative
Lowest HR
Lowest HR during operation
Time frame: intraoperative
Total ephedrine dosis
Ephedrine is a vasopressor used in case of hypotension to maintain mean arterial pressure \> 65 mmHg or to increase blood pressure to check surgical hemostasis
Time frame: intraoperative
Postoperative desaturation
SpO2 \< 94%
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Patient's comfort assessed in QoR-40 formulary
QoR-40 scale is used to measure the quality of recovery after surgery and anesthesia, it is a 40 item questionnaire that provides a score across five dimensions: patient support, comfort, emotions, physical independence, and pain. Formulary will assess first 24 hours following the operation and will be filled by the patient 7 days after operation
Time frame: 7 days postoperatively