Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Postoperative Pain; Opioid Use; Postoperative Nausea; Postoperative Vomiting
• Intervention / Treatment: Drug: Remifentanil [Ultiva]; Drug: Dexmedetomidine Hydrochloride [Dexdor]; Drug: Ketamine [Ketalar]; Drug: Lidocaine [Xylocaine 2%]; Drug: Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]; Drug: Fentanyl [Fentanyl WZF]

Detailed Description

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
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Piotr Mieszczański, MD; Phone Number: +48669643205; Email: piotr.mieszczanski@gmail.com

Study Locations

• Poland
  • Warsaw, Poland, 02-005
    • Recruiting
    • Szpital Kliniczny Dzieciatka Jezus
    • Contact: Piotr Mieszczanski; Phone Number: +48669643205; Email: piotr.mieszczanski@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Opioid liberal group	Drug: Remifentanil [Ultiva]; Remifentanil TCI Minto Model will be used during induction in dosis 6 ng/ml and intraoperatively appropriately to maintain hemodynamical stability.
Experimental: Opioid free group	Drug: Dexmedetomidine Hydrochloride [Dexdor]; 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.; Drug: Ketamine [Ketalar]; Ketamine 0,5mg/kg IBW iv will be administered during induction of general anesthesia.; Drug: Lidocaine [Xylocaine 2%]; 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.; Drug: Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]; Magnesium Sulphate will be administered in dosis 50 mg/kg IBW iv intraoperatively.; Drug: Fentanyl [Fentanyl WZF]; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day "0"
Postoperative pain score in NRS scale	NRS range from 0 for no pain to 10 for worst pain imaginable	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	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	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	Day "1" assessed 24 hours after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative sedation score	1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive	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	Day "0", assessed 1,6,12 and 24 hours after operation
Rescue fentanyl administration dosis	In opioid free group, rescue fentanyl dosis will be administered if hypertension > 140/90 mmHg or tachycardia > 120/min occurs	intraoperative
Highest BP	Highest BP during operation	intraoperative
Lowest BP	Lowest BP during operation	intraoperative
Highest HR	Highest HR during operation	intraoperative
Lowest HR	Lowest HR during operation	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	intraoperative
Postoperative desaturation	SpO2 < 94%	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	7 days postoperatively

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Piotr Mieszczański, MD, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2020
• Primary Completion (Anticipated): June 4, 2022
• Study Completion (Anticipated): July 22, 2022

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Opioid free anesthesia; Laparoscopic sleeve gastrectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anticonvulsants; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Ketamine; Remifentanil; Fentanyl; Dexmedetomidine; Lidocaine; Magnesium Sulfate
• Other Study ID Numbers: OFA LSG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No