Skip to main content
OpenTrials
Completed

NCT Number: NCT03507634

Opioid Free Anesthesia in Bariatric Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Use Bariatric Surgery Candidate Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Pain Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LAU Medical Center

Beirut, Lebanon

About this study

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 .

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Opioid free Anesthesia dexmedetomidine and lidocaine

Drug

Opioid free anesthesia with dexmedetomidine and lidocaine

Opioid based anesthesia Fentanyl and Remifentanyl

Drug

Opioid based anesthesia with Fentanyl and Remifentanyl

Primary outcomes

  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 outcomes

  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

    • Mild, drowsy , easy to awake
    • moderate, easy to arouse
    • 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.

Sponsors and collaborators

Lead sponsor

Lebanese American University

Other

Registry information

Official study title

Opioid Free Anesthesia in Bariatric Surgery: A Prospective, Double-blinded, Randomized, Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2018
Registry last updated
Sep 29, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.