Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

NCT04260659 | Completed Phase 4

• 1 other identifier: OFA LSG
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Postoperative Pain; Postoperative Nausea; Postoperative Vomiting; Opioid Use

Keywords

Opioid free anesthesia; Laparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Postoperative sedation score

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

• Postoperative nausea and vomiting

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

• Rescue fentanyl administration dosis

  intraoperative

• Highest BP

  intraoperative

• Lowest BP

  intraoperative

Study Arms (2)

Opioid liberal group

ACTIVE COMPARATOR

Drug: Remifentanil [Ultiva]

Opioid free group

EXPERIMENTAL

Drug: Dexmedetomidine Hydrochloride [Dexdor]; Drug: Ketamine [Ketalar]; Drug: Lidocaine [Xylocaine 2%]; Drug: Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]; Drug: Fentanyl [Fentanyl WZF]

Interventions

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.

Opioid free group

Remifentanil [Ultiva] DRUG

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

Opioid liberal group

Ketamine [Ketalar] DRUG

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

Opioid free group

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.

Opioid free group

Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma] DRUG

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

Opioid free group

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.

Opioid free group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Szpital Kliniczny Dzieciatka Jezus

Warsaw, 02-005, Poland

Location

MeSH Terms

Conditions

Obesity; Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Dexmedetomidine; Remifentanil; Ketamine; Lidocaine; Magnesium Sulfate; Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Piotr Mieszczański, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 7, 2020
• Study Start: February 4, 2020
• Primary Completion: October 6, 2022
• Study Completion: February 22, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)