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NCT Number: NCT04260659

Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

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.

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Key information

Conditions

Obesity Body Weight Nausea Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Opioid Use Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea Postoperative Nausea and Vomiting Postoperative Pain Postoperative Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Szpital Kliniczny Dzieciatka Jezus

Warsaw, 02-005, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
  • Written informed consent

Exclusion criteria

  • Patient's refusal
  • Known allergies to study medication
  • Inability to comprehend or participate In pain scoring scale
  • Inability to use intravenous patient controlled analgesia
  • Changes of operation extent during procedure
  • Revisional operations

Treatment and study plan

Dexmedetomidine Hydrochloride [Dexdor]

Drug

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 [Ultiva]

Drug

Remifentanil TCI Minto Model will be used during induction in dosis 6 ng/ml and intraoperatively appropriately to maintain hemodynamical stability.

Ketamine [Ketalar]

Drug

Ketamine 0,5mg/kg IBW iv will be administered during induction of general anesthesia.

Lidocaine [Xylocaine 2%]

Drug

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 [Inj. Magnesii Sulfurici Polpharma]

Drug

Magnesium Sulphate will be administered in dosis 50 mg/kg IBW iv intraoperatively.

Fentanyl [Fentanyl WZF]

Drug

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.

Primary outcomes

  1. Total postoperative oxycodone consumption

    Time frame: Day "0"

    PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes

  2. Postoperative pain score in NRS scale

    Time frame: Day "0", assessed 1 hour after operation

    NRS range from 0 for no pain to 10 for worst pain imaginable

  3. Postoperative pain score in NRS scale

    Time frame: Day "0", assessed 6 hours after operation

    NRS range from 0 for no pain to 10 for worst pain imaginable

  4. Postoperative pain score in NRS scale

    Time frame: Day "0", assessed 12 hours after operation

    NRS range from 0 for no pain to 10 for worst pain imaginable

  5. Postoperative pain score in NRS scale

    Time frame: Day "1" assessed 24 hours after operation

    NRS range from 0 for no pain to 10 for worst pain imaginable

Secondary outcomes

  1. Postoperative sedation score

    Time frame: Day "0", assessed 1,6,12 and 24 hours after operation

    1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive

  2. Postoperative nausea and vomiting

    Time frame: Day "0", assessed 1,6,12 and 24 hours after operation

    Simplified PONV impact scale 0-6 0 - no nausea nor vomiting 6 - >3 episodes of vomiting and nausea all of the time

  3. Rescue fentanyl administration dosis

    Time frame: intraoperative

    In opioid free group, rescue fentanyl dosis will be administered if hypertension > 140/90 mmHg or tachycardia > 120/min occurs

  4. Highest BP

    Time frame: intraoperative

    Highest BP during operation

  5. Lowest BP

    Time frame: intraoperative

    Lowest BP during operation

  6. Highest HR

    Time frame: intraoperative

    Highest HR during operation

  7. Lowest HR

    Time frame: intraoperative

    Lowest HR during operation

  8. Total ephedrine dosis

    Time frame: intraoperative

    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

  9. Postoperative desaturation

    Time frame: Day "0", assessed 1,6,12 and 24 hours after operation

    SpO2 < 94%

  10. Patient's comfort assessed in QoR-40 formulary

    Time frame: 7 days postoperatively

    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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy: Clinical, Randomised Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 7, 2020
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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