- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507634
Opioid Free Anesthesia in Bariatric Surgery
Opioid Free Anesthesia in Bariatric Surgery: A Prospective, Double-blinded, Randomized, Controlled Clinical Trial
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beirut, Lebanon
- LAU Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
Opioid free anesthesia with dexmedetomidine and lidocaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
48 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 hours postoperative
|
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.
|
48 hours postoperative
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Postoperative morphine Side effects: Sedation score .for 48 hours
Time Frame: 48 hours postoperative
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Sedation score: 0 alert
|
48 hours postoperative
|
Postoperative morphine Side effects:Respiratory depression for 48 hours
Time Frame: 48 hours postoperative
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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. |
48 hours postoperative
|
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. |
48 hours postoperative
|
Postoperative morphine Side effects: Itching for 48 hours
Time Frame: 48 hours postoperative
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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.
|
48 hours postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Narcotics
- Membrane Transport Modulators
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Anesthetics
- Remifentanil
- Fentanyl
- Dexmedetomidine
- Lidocaine
- Analgesics, Opioid
Other Study ID Numbers
- LAUMCRH.HB2.28/Mar/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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