ObesityPhase 2/3NCT02213159
Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery
A Phase 2/3 study testing Dexmedetomidine and Morphine in people with Obesity and Sleep Apnea, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will reduce postoperative morphine consumption and improve postoperative quality of recovery as compared to morphine in patients undergoing laparoscopic bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Sleep Apnea, Diabetes
- What is being tested?
- Dexmedetomidine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- Jul 2014to Dec 2015
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index > 40 kg/m2 or BMI > 35 kg/m2 with comorbid conditions such as hypertension, diabetes or sleep apnea
- American Society of Anesthesiologists class I or II
- Undergoing laparoscopic sleeve gastrectomy bariatric surgery
Who cannot join
- Allergy to morphine or its derivatives
- Allergy to α-2 adrenergic agonists
- weight over 180 kg
- history of uncontrolled hypertension
- heart block greater than first degree
- prolonged QT interval
Show all 11Show fewer
- clinically significant neurologic, cardiovascular, renal, hepatic, or gastrointestinal diseases
- received an opioid analgesic medication within a 24 h period prior to surgery
- history of alcohol, drug abuse or chronic opioid intake
- history of psychiatric disorder
- pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery
The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will reduce postoperative morphine consumption and improve postoperative quality of recovery as compared to morphine in patients undergoing laparoscopic bariatric surgery.
Read the detailed description
effect of Dexmedetomidine bolus on postoperative morphine requirements
- Conditions
- Obesity, Sleep Apnea, Diabetes, Hypertension
- Being tested
- Dexmedetomidine, Morphine
- Keywords
- Dexmedetomidine, bariatric surgery, postoperative pain, morphine consumption, Quality of recovery
- Medical subject headings
- Obesity, Sleep Apnea Syndromes, Diabetes Mellitus, Hypertension, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
MorphineDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | prior to anticipated end of surgery bolus of 1 microgram/kg Dexmedetomidine intravenously over 10 minutes followed by 0.5 micrograms/kilogram/hour intravenous infusion until removal of laparoscopes Receives: Drug: Dexmedetomidine |
| Morphine | Active comparator | prior to anticipated completion of surgery morphine 0.08 mg/kilogram intravenous bolus over 10 minutes followed by a saline infusion until removal of the laparoscopes Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)
Measured: At discharge from the PACU
Secondary outcomes (10)
Time to first morphine requirement in PACU
Measured: in the PACU
Numeric Rating Scale (NRS) for Pain
Measured: in the PACU and at 24 hours
NRS for nausea
Measured: in the PACU
incidence of pruritus
Measured: in the PACU
incidence of vomiting or retching
Measured: in the PACU
incidence of respiratory complications
Measured: in the PACU
time to discharge readiness in PACU
Measured: in the PACU
total morphine consumption at 24 hours
Measured: at 24 hours
Quality of Recovery (QoR-40) score at 24 hours
Measured: at 24 hours
overall satisfaction at one month
Measured: one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine Zeeni, M.D., Principal investigator, AUBMCSahar Siddik, M.D., Principal investigator, AUBMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213159
- Sponsor's protocol ID
- ANES.CZ.2
- Status last verified
- Jan 2016
- First submitted
- 8 Aug 2014
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02213159
- Acronym / sponsor ID
- ANES.CZ.2
- Conditions
- Obesity, Sleep Apnea, Diabetes, Hypertension
- Keywords
- Dexmedetomidine, bariatric surgery, postoperative pain, morphine consumption, Quality of recovery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Aug 2014 (estimated)
- 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.
The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will reduce postoperative morphine consumption and improve postoperative quality of recovery as compared to morphine in patients undergoing laparoscopic bariatric surgery.
Detailed description
effect of Dexmedetomidine bolus on postoperative morphine requirements
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidineprior to anticipated end of surgery bolus of 1 microgram/kg Dexmedetomidine intravenously over 10 minutes followed by 0.5 micrograms/kilogram/hour intravenous infusion until removal of laparoscopes |
| Morphine | Active comparator | Drug: Morphineprior to anticipated completion of surgery morphine 0.08 mg/kilogram intravenous bolus over 10 minutes followed by a saline infusion until removal of the laparoscopes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index > 40 kg/m2 or BMI > 35 kg/m2 with comorbid conditions such as hypertension, diabetes or sleep apnea
- American Society of Anesthesiologists class I or II
- Undergoing laparoscopic sleeve gastrectomy bariatric surgery
Key exclusion criteria (11 listed)
- Allergy to morphine or its derivatives
- Allergy to α-2 adrenergic agonists
- weight over 180 kg
- history of uncontrolled hypertension
- heart block greater than first degree
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 |
|---|---|---|
| DexmedetomidineAlso: Precedex | Drug | Dexmedetomidine |
| Morphine | Drug | Morphine |
Primary outcome
Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)
Time frame: At discharge from the PACU
10 secondary outcomes
Time to first morphine requirement in PACU
Time frame: in the PACU
Numeric Rating Scale (NRS) for Pain
Time frame: in the PACU and at 24 hours
NRS for nausea
Time frame: in the PACU
incidence of pruritus
Time frame: in the PACU
incidence of vomiting or retching
Time frame: in the PACU
incidence of respiratory complications
Time frame: in the PACU
time to discharge readiness in PACU
Time frame: in the PACU
total morphine consumption at 24 hours
Time frame: at 24 hours
Quality of Recovery (QoR-40) score at 24 hours
Time frame: at 24 hours
overall satisfaction at one month
Time frame: one month after surgery
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 13 Jul 2016.
- 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.
Carine Zeeni, M.D. principal investigator
AUBMC
Sahar Siddik, M.D. principal investigator
AUBMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine and Morphine in people with Obesity and Sleep Apnea, run by American University of Beirut Medical Center 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 11 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 13 Jul 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total dose of morphine consumed in Post Anesthesia Care Unit (PACU) (time frame: At discharge from the PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2016.