Bariatric Surgery CandidatePhase 4NCT03809182
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
A Phase 4 study testing Dexmedetomidine, 0.9% Sodium-chloride and Fentanyl in people with Bariatric Surgery Candidate and Glucose Intolerance, run by Pontificia Universidad Catolica de Chile.
Trial summary
This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate, Glucose Intolerance, Insulin Resistance
- What is being tested?
- Dexmedetomidine, 0.9% Sodium-chloride and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 27 Sep 2012to 25 Jul 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obese patient (BMI>30)
- American Society of Anesthesiologists grades II or III
- Diagnosis of impaired glucose tolerance
- Undergoing sleeve gastrectomy
Who cannot join
- Baseline glucose > 200mg/dl
- Diagnosis of Diabetes
- Under corticosteroids treatment
- Oral hypoglycemic medication within 7 days previous surgery
- Use of insulin within 24h previous surgery
- Allergy to any drug used in the study
About this study
Official title: Effect of Dexmedetomidine on Postoperative Glucose Levels and Insulin Secretion Patterns in Obese Patients With Impaired Glucose Tolerance.
This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery.
Read the detailed description
A prospective, double-blind, randomized controlled trial was performed. Consenting obese adult patients with impaired glucose tolerance, undergoing bariatric surgery, were randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1 ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery. Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose and insulin levels were taken every 2 hours during the first 12 hours from the onset of the drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score, the occurrence of emesis, and postoperative sedation levels were recorded as secondary outcomes.
- Being tested
- Dexmedetomidine, 0.9% Sodium-chloride, Fentanyl, Morphine Sulfate
- Keywords
- Impaired Glucose Tolerance, Obese patients, Dexmedetomidine
- Medical subject headings
- Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
0.9% Sodium-chlorideDrug
Also called Normal saline
The same infusion rate used in the dexmedetomidine group.
FentanylDrug
Also called Sublimaze
Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine SulfateDrug
Also called Morphine
Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | After anesthesia induction, patients who were randomized to the Dexmedetomidine group received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Receives: Drug: Dexmedetomidine; Drug: Fentanyl; Drug: Morphine Sulfate |
| 0.9% Sodium-chloride | Placebo comparator | After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Receives: Drug: 0.9% Sodium-chloride; Drug: Fentanyl; Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic Glucose Levels (mg/dl).
Change of baseline glucose levels within the first 12 postoperative hours.
Measured: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine
Plasmatic Insulin Levels (uU/ml).
Change of baseline insulin levels within the first 12 postoperative hours.
Measured: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine
Secondary outcomes (5)
Fentanyl Consumption.
Amount of fentanyl (ug/kg) intraoperatively administered.
Measured: Since the beginning of anesthesia until the end of it, an average of one hour and a half.
Amount (mg) of Morphine Consumed.
Morphine consumption in the first 24 postoperative hours.
Measured: At 24h postoperative hours.
Pain Scores in the First 24 Postoperative Hours.
Visual analogue scale (VAS), provided by patients, ranging from 0 to 10 (0= no pain and 10= worst possible pain). We considered a pain score between 1-3, 4-6 and 7-10 as mild, moderate and severe pain, respectively.
Measured: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).
Sedation-agitation Scores in the First 12 Postoperative Hours.
Sedation-agitation scale (SAS), ranging from 1 to 7 (1=unarousable, 2=very sedated, 3=sedated, 4=calm and cooperative, 5=agitated, 6=very agitated and 7=dangerous agitation).
Measured: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).
Postoperative Nausea and Vomiting.
Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.
Measured: Postoperative nausea and vomiting during the first 12 postoperative hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start27 Sep 2012
- Primary completion25 Jul 2013
- Study completion25 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Vega, Pontificia Universidad Catolica de Chile
- Investigators
- Mauricio Ibacache, MD, PhD, Study director, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809182
- Sponsor's protocol ID
- Dexmedetomidine and glycemia.
- Status last verified
- Sep 2020
- First submitted
- 30 Dec 2018
- Last updated
- 1 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Postoperative Glucose Levels and Insulin Secretion Patterns in Obese Patients With Impaired Glucose Tolerance.
- ClinicalTrials.gov ID
- NCT03809182
- Acronym / sponsor ID
- Dexmedetomidine and glycemia.
- Keywords
- Impaired Glucose Tolerance, Obese patients, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 27 Sep 2012 (actual)
- Primary completion
- 25 Jul 2013 (actual)
- Study completion
- 25 Jul 2013 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Posted 1 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery.
Detailed description
A prospective, double-blind, randomized controlled trial was performed. Consenting obese adult patients with impaired glucose tolerance, undergoing bariatric surgery, were randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1 ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery. Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose and insulin levels were taken every 2 hours during the first 12 hours from the onset of the drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score, the occurrence of emesis, and postoperative sedation levels were recorded as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: Fentanyl, Drug: Morphine SulfateAfter anesthesia induction, patients who were randomized to the Dexmedetomidine group received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. |
| 0.9% Sodium-chloride | Placebo comparator | Drug: 0.9% Sodium-chloride, Drug: Fentanyl, Drug: Morphine SulfateAfter anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Obese patient (BMI>30)
- American Society of Anesthesiologists grades II or III
- Diagnosis of impaired glucose tolerance
- Undergoing sleeve gastrectomy
Key exclusion criteria (6 listed)
- Baseline glucose > 200mg/dl
- Diagnosis of Diabetes
- Under corticosteroids treatment
- Oral hypoglycemic medication within 7 days previous surgery
- Use of insulin within 24h previous surgery
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: PrecedexA bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. | Drug | Dexmedetomidine |
| 0.9% Sodium-chlorideAlso: Normal salineThe same infusion rate used in the dexmedetomidine group. | Drug | 0.9% Sodium-chloride |
| FentanylAlso: SublimazeIntraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). | Drug | 0.9% Sodium-chloride, Dexmedetomidine |
| Morphine SulfateAlso: MorphineBoluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room. | Drug | 0.9% Sodium-chloride, Dexmedetomidine |
Primary outcome
Plasmatic Glucose Levels (mg/dl).
Time frame: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine
Change of baseline glucose levels within the first 12 postoperative hours.
Plasmatic Insulin Levels (uU/ml).
Time frame: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine
Change of baseline insulin levels within the first 12 postoperative hours.
5 secondary outcomes
Fentanyl Consumption.
Time frame: Since the beginning of anesthesia until the end of it, an average of one hour and a half.
Amount (mg) of Morphine Consumed.
Time frame: At 24h postoperative hours.
Pain Scores in the First 24 Postoperative Hours.
Time frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).
Sedation-agitation Scores in the First 12 Postoperative Hours.
Time frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).
Postoperative Nausea and Vomiting.
Time frame: Postoperative nausea and vomiting during the first 12 postoperative hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mauricio Ibacache, MD, PhD study director
Pontificia Universidad Catolica de Chile
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, 0.9% Sodium-chloride and Fentanyl in people with Bariatric Surgery Candidate and Glucose Intolerance, run by Pontificia Universidad Catolica de Chile.
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 4 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 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plasmatic Glucose Levels (mg/dl). (time frame: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine). The study lists 2 primary outcomes in all. 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 1 Oct 2020.