Opioid UseNCT03507634
Opioid Free Anesthesia in Bariatric Surgery
A study testing Opioid free Anesthesia dexmedetomidine and lidocaine and Opioid based anesthesia Fentanyl and Remifentanyl in people with Opioid Use and Postoperative Pain, run by Lebanese American University at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use, Postoperative Pain, Postoperative Nausea and Vomiting
- What is being tested?
- Opioid free Anesthesia dexmedetomidine and lidocaine and Opioid based anesthesia Fentanyl and Remifentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteLebanon
- Study dates
- 11 Apr 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group: 18-65 years old
- American Society of Anesthesiologists (ASA )class I and II
- Indicated laparoscopic bariatric surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Free Anesthesia in Bariatric Surgery: A Prospective, Double-blinded, Randomized, Controlled Clinical Trial
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
Read the 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 .
- Conditions
- Opioid Use, Postoperative Pain, Postoperative Nausea and Vomiting, Bariatric Surgery Candidate
- Being tested
- Opioid free Anesthesia dexmedetomidine and lidocaine, Opioid based anesthesia Fentanyl and Remifentanyl
- Keywords
- Lidocaine, Dexmedetomidine, Opioid Free, Bariatric surgery
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid free Anesthesia dexmedetomidine and lidocaineDrug
Opioid free anesthesia with dexmedetomidine and lidocaine
Opioid based anesthesia Fentanyl and RemifentanylDrug
Opioid based anesthesia with Fentanyl and Remifentanyl
| Study group | Role | What they receive |
|---|---|---|
| Opioid Based Anesthesia | Active comparator | 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. Receives: Drug: Opioid based anesthesia Fentanyl and Remifentanyl |
| Opioid Free Anesthesia | Active comparator | 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. Receives: Drug: Opioid free Anesthesia dexmedetomidine and lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score for 48 hours
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.
Measured: 48 hours postoperative
Secondary outcomes (6)
Postoperative morphine consumption at the PACU (Post Anesthesia Care Unit)
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.
Measured: 2 hours postoperative
Postoperative morphine consumption at the surgical ward for 48 hours
Post-operative opioid consumption will be based on the amount in mg (milligrams) of opioid required in the 48 hours postoperative.
Measured: 48 hours postoperative
Postoperative morphine Side effects: Sedation score .for 48 hours
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.
Measured: 48 hours postoperative
Postoperative morphine Side effects:Respiratory depression for 48 hours
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.
Measured: 48 hours postoperative
Postoperative morphine Side effects: Nausea vomiting for 48 hours
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.
Measured: 48 hours postoperative
Postoperative morphine Side effects: Itching for 48 hours
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.
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start11 Apr 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lebanese American University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanane Barakat, Lebanese American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507634
- Sponsor's protocol ID
- LAUMCRH.HB2.28/Mar/2018
- Status last verified
- Sep 2020
- First submitted
- 12 Apr 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barakat H, Gholmieh L, Nader JA, Karam VY, Albaini O, Helou ME, Al Nawwar R. Opioid-free versus opioid-based anesthesia in laparoscopic sleeve gastrectomy: a single-center, randomized, controlled trial. Perioper Med (Lond). 2025 Feb 5;14(1):16. doi: 10.1186/s13741-024-00486-5.
PubMed 39910664
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Anesthesia in Bariatric Surgery: A Prospective, Double-blinded, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03507634
- Acronym / sponsor ID
- LAUMCRH.HB2.28/Mar/2018
- Conditions
- Opioid Use, Postoperative Pain, Postoperative Nausea and Vomiting, Bariatric Surgery Candidate
- Keywords
- Lidocaine, Dexmedetomidine, Opioid Free, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lebanese American UniversityUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Based Anesthesia | Active comparator | Drug: Opioid based anesthesia Fentanyl and RemifentanylGeneral 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 Free Anesthesia | Active comparator | Drug: Opioid free Anesthesia dexmedetomidine and lidocaineGeneral 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age group: 18-65 years old
- American Society of Anesthesiologists (ASA )class I and II
- Indicated laparoscopic bariatric surgery
Key exclusion criteria (6 listed)
- Renal, hepatic or cardiac insufficiency
- Positive pregnancy test
- Alcohol or drug abuse
- Psychiatric disease
- History of chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid free Anesthesia dexmedetomidine and lidocaineOpioid free anesthesia with dexmedetomidine and lidocaine | Drug | Opioid Free Anesthesia |
| Opioid based anesthesia Fentanyl and RemifentanylOpioid based anesthesia with Fentanyl and Remifentanyl | Drug | Opioid Based Anesthesia |
Primary outcome
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.
6 secondary outcomes
Postoperative morphine consumption at the PACU (Post Anesthesia Care Unit)
Time frame: 2 hours postoperative
Postoperative morphine consumption at the surgical ward for 48 hours
Time frame: 48 hours postoperative
Postoperative morphine Side effects: Sedation score .for 48 hours
Time frame: 48 hours postoperative
Postoperative morphine Side effects:Respiratory depression for 48 hours
Time frame: 48 hours postoperative
Postoperative morphine Side effects: Nausea vomiting for 48 hours
Time frame: 48 hours postoperative
Postoperative morphine Side effects: Itching for 48 hours
Time frame: 48 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Derived from this study: PubMed 39910664Barakat H, Gholmieh L, Nader JA, Karam VY, Albaini O, Helou ME, Al Nawwar R. Opioid-free versus opioid-based anesthesia in laparoscopic sleeve gastrectomy: a single-center, randomized, controlled trial. Perioper Med (Lond). 2025 Feb 5;14(1):16. doi: 10.1186/s13741-024-00486-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid free Anesthesia dexmedetomidine and lidocaine and Opioid based anesthesia Fentanyl and Remifentanyl in people with Opioid Use and Postoperative Pain, run by Lebanese American University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score for 48 hours (time frame: 48 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03507634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.