Opioid Free Anesthesia in Bariatric Surgery

• ClinicalTrials.gov Identifier: NCT03507634
• Recruitment Status: Completed
• First Posted: April 25, 2018
• Last Update Posted: September 29, 2020
• Sponsor: Lebanese American University
• Information provided by (Responsible Party): Hanane Barakat, Lebanese American University

Tracking Information

• First Submitted Date: April 12, 2018
• First Posted Date: April 25, 2018
• Last Update Posted Date: September 29, 2020
• Actual Study Start Date: April 11, 2018
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 3, 2018)

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.

Original Primary Outcome Measures (submitted: April 24, 2018)

Postoperative pain score [ 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 hours to be repeated every 6 hours thereafter up to 48 hours post surgery

Current Secondary Outcome Measures (submitted: May 3, 2018)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: April 24, 2018)

• 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.
• Postoperative morphine consumption at the surgical ward [ Time Frame: 48 hours postoperative ]
  Post-operative opioid consumption will be based on the amount in mg (milligrams) of opioid required.
• Postoperative morphine Side effects: Sedation score . [ 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 every 6 hours thereafter up to 48 hours.
• Postoperative morphine Side effects:Respiratory depression [ 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 every 6 hours thereafter up to 48 hours.
• Postoperative morphine Side effects: Nausea vomiting [ 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.
• Postoperative morphine Side effects: Itching [ 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 .

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Opioid Use
• Postoperative Pain
• Postoperative Nausea and Vomiting
• Bariatric Surgery Candidate

Intervention

• Drug: Opioid free Anesthesia dexmedetomidine and lidocaine
  Opioid free anesthesia with dexmedetomidine and lidocaine
• Drug: Opioid based anesthesia Fentanyl and Remifentanyl
  Opioid based anesthesia with Fentanyl and Remifentanyl

Study Arms

• 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.
  Intervention: Drug: Opioid based anesthesia 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.
  Intervention: Drug: Opioid free Anesthesia dexmedetomidine and lidocaine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 24, 2018): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 30, 2020
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Lebanon

Administrative Information

• NCT Number: NCT03507634
• Other Study ID Numbers: LAUMCRH.HB2.28/Mar/2018
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Hanane Barakat, Lebanese American University
• Study Sponsor: Lebanese American University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Lebanese American University
• Verification Date: September 2020