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Opioid Free Anesthesia in Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT03507634
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Hanane Barakat, Lebanese American University

Brief Summary:
This study compares the intraoperative opioid free anesthesia approach in laparoscopic bariatric surgery to a conventional opioid- based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine

Condition or disease Intervention/treatment Phase
Opioid Use Postoperative Pain Postoperative Nausea and Vomiting Bariatric Surgery Candidate Drug: Opioid free Anesthesia dexmedetomidine and lidocaine Drug: Opioid based anesthesia Fentanyl and Remifentanyl Not Applicable

Detailed Description:

Since optimal analgesia for the obese patients undergoing bariatric surgeries has always been challenging, and knowing the comorbidities and physiological changes in this population, use of opioid-sparing agents during anesthesia has attracted substantial research.the use of opioids in the perioperative period in obese patients is associated with an increased risk of complications . They are especially more sensitive to the respiratory depressant effect of opioids , thus any analgesic alternative without further compromising airway tone would be a desirable choice.

Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic and sedative properties, without compromising airway tone and reflexes .

Lidocaine, a local anesthetic that has been shown to be an effective multimodal strategy to minimize postoperative pain was evaluated in one study involving obese patients undergoing bariatric surgery. Its usage was associated with an improved quality of recovery compared to placebo .


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Opioid Free Anesthesia in Bariatric Surgery: A Prospective, Double-blinded, Randomized, Controlled Clinical Trial
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : October 10, 2019
Estimated Study Completion Date : April 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Opioid Based Anesthesia
General anesthesia will be induced using Propofol , fentanyl , and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with Remi-fentanyl and Sevoflurane.
Drug: Opioid based anesthesia Fentanyl and Remifentanyl
Opioid based anesthesia with Fentanyl and Remifentanyl

Active Comparator: Opioid Free Anesthesia
General anesthesia will be induced using dexmedetomidine and lidocaine started 10 minutes before induction, Propofol and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with IV infusion of dexmedetomidine , lidocaine and Sevoflurane.
Drug: Opioid free Anesthesia dexmedetomidine and lidocaine
Opioid free anesthesia with dexmedetomidine and lidocaine




Primary Outcome Measures :
  1. Postoperative pain score for 48 hours [ Time Frame: 48 hours postoperative ]
    Measure the pain score using the Visual Analogue Scale (VAS), The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The score ranges from 0 to 100 mm. A higher score indicates greater pain intensity. The distribution pain is the following:no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 and every 6 hours up to 48 hours post surgery.


Secondary Outcome Measures :
  1. Postoperative morphine consumption at the PACU (Post Anesthesia Care Unit) [ Time Frame: 2 hours postoperative ]
    After the surgery the patient will go to the PACU (Post Anesthesia Care Unit). the patient will receive morphine if the pain score is more than 4. the total dose of morphine in mg (milligrams) will be documented.

  2. Postoperative morphine consumption at the surgical ward for 48 hours [ Time Frame: 48 hours postoperative ]
    Post-operative opioid consumption will be based on the amount in mg (milligrams) of opioid required in the 48 hours postoperative.

  3. Postoperative morphine Side effects: Sedation score .for 48 hours [ Time Frame: 48 hours postoperative ]

    Sedation score:

    0 alert

    1. Mild, drowsy , easy to awake
    2. moderate, easy to arouse
    3. Severe: somnolent difficult to arouse 4:sleeping The Sedation score will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and then every 6 hours up to 48 hours.

  4. Postoperative morphine Side effects:Respiratory depression for 48 hours [ Time Frame: 48 hours postoperative ]

    Assess the respiratory rate : The number of breaths per minute. In practice, the respiratory rate is usually determined by counting the number of times the chest rises or falls per minute.

    The respiratory rate will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and then every 6 hours up to 48 hours.


  5. Postoperative morphine Side effects: Nausea vomiting for 48 hours [ Time Frame: 48 hours postoperative ]

    Degree of nausea vomiting using the verbal rating score from 0 to 10 :

    0= no nausea/ Vomiting, 10: worst possible nausea vomiting.

    The degree of nausea vomiting will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.


  6. Postoperative morphine Side effects: Itching for 48 hours [ Time Frame: 48 hours postoperative ]
    Itching: presence or absence The presence or absence of itching will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age group: 18-65 years old
  • American Society of Anesthesiologists (ASA )class I and II
  • Indicated laparoscopic bariatric surgery

Exclusion Criteria:

  • Renal, hepatic or cardiac insufficiency
  • Positive pregnancy test
  • Alcohol or drug abuse
  • Psychiatric disease
  • History of chronic pain
  • Allergy or contraindication to any of the study drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507634


Contacts
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Contact: Hanane Barakat, MD +9611200800 ext 5168 hanane.barakat@lau.edu.lb
Contact: Vanda Abi Raad, MD +9611200800 ext 5168 vanda.abiraad@lau.edu.lb

Locations
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Lebanon
LAU Medical Center Recruiting
Beirut, Lebanon
Contact: Hanane Barakat, MD    +9611200800 ext 5168    hanane.barakat@lau.edu.lb   
Contact: Vanda Abi Raad, MD    +9611200800 ext 5168    vanda.abiraad@lau.edu.lb   
Sponsors and Collaborators
Lebanese American University

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Responsible Party: Hanane Barakat, MD, Lebanese American University
ClinicalTrials.gov Identifier: NCT03507634     History of Changes
Other Study ID Numbers: LAUMCRH.HB2.28/Mar/2018
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hanane Barakat, Lebanese American University:
Lidocaine
Dexmedetomidine
Opioid Free
Bariatric surgery

Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Nausea
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Anesthetics
Lidocaine
Fentanyl
Dexmedetomidine
Remifentanil
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics
Hypnotics and Sedatives
Analgesics, Non-Narcotic