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
|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|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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 ]
- 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.
- 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.
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
|Contact: Hanane Barakat, MD||+9611200800 ext email@example.com|
|Contact: Vanda Abi Raad, MD||+9611200800 ext firstname.lastname@example.org|
|LAU Medical Center||Recruiting|
|Contact: Hanane Barakat, MD +9611200800 ext 5168 email@example.com|
|Contact: Vanda Abi Raad, MD +9611200800 ext 5168 firstname.lastname@example.org|