A Phase 4 interventional study of Dexmedetomidine and 0.9% Sodium-chloride in Bariatric Surgery Candidate, Glucose Intolerance and Insulin Resistance, sponsored by Pontificia Universidad Catolica de Chile. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-10-01.
Sponsored by Pontificia Universidad Catolica de Chile · Phase 4, Interventional, and Treatment
This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery.
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.
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Exclusion Criteria:
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.
Drug: Dexmedetomidine · Drug: Fentanyl · Drug: Morphine Sulfate
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.
Drug: 0.9% Sodium-chloride · Drug: Fentanyl · Drug: Morphine Sulfate
A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Also known as: Precedex
The same infusion rate used in the dexmedetomidine group.
Also known as: Normal saline
Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Also known as: Sublimaze
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.
Also known as: Morphine
Plasmatic Glucose Levels (mg/dl).
Change of baseline glucose levels within the first 12 postoperative hours.
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
Plasmatic Insulin Levels (uU/ml).
Change of baseline insulin levels within the first 12 postoperative hours.
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
Fentanyl Consumption.
Amount of fentanyl (ug/kg) intraoperatively administered.
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.
Morphine consumption in the first 24 postoperative hours.
Time frame: 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.
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.
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).
Time frame: 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.
Time frame: Postoperative nausea and vomiting during the first 12 postoperative hours.
The patients were recruited at the Pontifical Catholic University Hospital between 2012 and 2013. Twenty patients were assigned to each arm to allow some dropouts. Nonetheless, every randomized patient included in the study was analyzed at the end of it (intention to treat analysis).
| Milestone | Dexmedetomidine | 0.9% Sodium-chloride |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
Change of baseline glucose levels within the first 12 postoperative hours.
| mg/dl | Dexmedetomidine | 0.9% Sodium-chloride |
|---|---|---|
| Baseline level (T0) | 80 ± 15 | 82 ± 8 |
| Hour 2 (T1) | 114 ± 29 | 111 ± 20 |
| Hour 4 (T2) | 124 ± 25 | 129 ± 17 |
| Hour 6 (T3) | 131 ± 60 | 120 ± 16 |
| Hour 8 (T4) | 122 ± 41 | 118 ± 17 |
| Hour 10 (T5) | 130 ± 62 | 117 ± 18 |
| Hour 12 (T6) | 125 ± 31 | 117 ± 17 |
Change of baseline insulin levels within the first 12 postoperative hours.
| uU/dl | Dexmedetomidine | 0.9% Sodium-chloride |
|---|---|---|
| Baseline level (T0) | 10.5 ± 6 | 11.2 ± 6 |
| Hour 2 (T1) | 11.8 ± 9 | 19.9 ± 11.8 |
| Hour 4 (T2) | 16.7 ± 9.5 | 30.3 ± 19.9 |
| Hour 6 (T3) | 16.8 ± 11.4 | 23 ± 11.4 |
| Hour 8 (T4) | 16.6 ± 8.9 | 21.5 ± 10.4 |
| Hour 10 (T5) | 16 ± 10 | 24 ± 17.7 |
| Hour 12 (T6) | 16.6 ± 9.2 | 25.9 ± 18.3 |
Amount of fentanyl (ug/kg) intraoperatively administered.
| mcg/kg | Dexmedetomidine | 0.9% Sodium-chloride |
|---|---|---|
| Fentanyl Consumption. | 6.0 ± 2.2 | 7 ± 2.4 |
Morphine consumption in the first 24 postoperative hours.
| mg | Dexmedetomidine | 0.9% Sodium-chloride |
|---|---|---|
| Amount (mg) of Morphine Consumed. | 26 ± 14.4 | 18.4 ± 10.6 |
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.
| units on a scale | Dexmedetomidine | 0.9% Sodium-chloride |
|---|---|---|
| Hour 2 (T1) Pain at rest | 0 (0 to 2) | 0 (0 to 4) |
| Hour 2 (T1) Pain at movement | 0 (0 to 2) | 0 (0 to 5) |
| Hour 4 (T2) Pain at rest | 4 (2 to 5) | 3 (2 to 4) |
| Hour 4 (T2) Pain at movement | 5 (4 to 6) | 4 (3 to 6) |
| Hour 6 (T3) Pain at rest | 3 (1 to 5) | 2 (2 to 3) |
| Hour 6 (T3) Pain at movement | 4 (2 to 6) | 4 (2 to 5) |
| Hour 8 (T4) Pain at rest | 3 (1 to 5) | 1 (0 to 3) |
| Hour 8 (T4) Pain at movement | 4 (3 to 7) | 4 (2 to 4) |
| Hour 10 (T5) Pain at rest | 3 (1 to 4) | 1 (0 to 2) |
| Hour 10 (T5) Pain at movement | 5 (3 to 6) | 3 (2 to 5) |
| Hour 12 (T6) Pain at rest | 3 (0 to 4) | 1 (0 to 2) |
| Hour 12 (T6) Pain at movement | 3 (2 to 5) | 3 (2 to 4) |
| Hour 24 (T7) Pain at rest | 2 (0 to 3) | 0 (0 to 2) |
| Hour 24 (T7) Pain at movement | 3 (1 to 4) | 3 (1 to 3) |
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).
| score on a scale | Dexmedetomidine | 0.9% Sodium-chloride |
|---|---|---|
| Hour 2 (T1) | 3 (3 to 4) | 4 (4 to 4) |
| Hour 4 (T2) | 4 (3 to 4) | 4 (4 to 4) |
| Hour 6 (T3) | 4 (4 to 4) | 4 (4 to 4) |
| Hour 8 (T4) | 4 (4 to 4) | 4 (4 to 4) |
| Hour 10 (T5) | 4 (4 to 4) | 4 (4 to 4) |
| Hour 12 (T6) | 4 (4 to 4) | 4 (4 to 4) |
Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.
| Participants | Dexmedetomidine | 0.9% Sodium-chloride |
|---|---|---|
| Postoperative Nausea and Vomiting. | 16 | 19 |
Collected over Intraop and 24 hours post-surgery.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexmedetomidine | 0/20 (0%) | 0/20 (0%) | 17/20 (85%) |
| 0.9% Sodium-chloride | 0/20 (0%) | 0/20 (0%) | 10/20 (50%) |
| Event | Dexmedetomidine | 0.9% Sodium-chloride |
|---|---|---|
| Hypotension associated with bradycardiaCardiac disorders | 10/20 | 2/20 |
| Isolated BradycardiaCardiac disorders | 7/20 | 4/20 |
| Isolated hypotensionCardiac disorders | 2/20 | 4/20 |
Baseline characteristics from the entire study population were measured.
| Age, Categorical(Participants) | Dexmedetomidine | 0.9% Sodium-chloride | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 20 | 40 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Dexmedetomidine | 0.9% Sodium-chloride | Total |
|---|---|---|---|
| Mean | 33 ± 10.2 | 31.5 ± 9.9 | 32 ± 10 |
| Sex: Female, Male(Participants) | Dexmedetomidine | 0.9% Sodium-chloride | Total |
|---|---|---|---|
| Female | 20 | 15 | 35 |
| Male | 0 | 5 | 5 |
| Region of Enrollment(participants) | Dexmedetomidine | 0.9% Sodium-chloride | Total |
|---|---|---|---|
| Chile | 20 | 20 | 40 |
| Body Mass Index (BMI)(kg/m^2) | Dexmedetomidine | 0.9% Sodium-chloride | Total |
|---|---|---|---|
| Mean | 34.4 ± 2.5 | 35.2 ± 3.6 | 34.8 ± 3.1 |
| ASA physical status II(Participants) | Dexmedetomidine | 0.9% Sodium-chloride | Total |
|---|---|---|---|
| Count of participants | 20 | 20 | 40 |
| Risk score for postoperative nausea and vomiting (PONV) in adults(Participants) | Dexmedetomidine | 0.9% Sodium-chloride | Total |
|---|---|---|---|
| 0 risk factor | 0 | 0 | 0 |
| 1 risk factor | 0 | 4 | 4 |
| 2 risk factors | 14 | 9 | 23 |
| 3 risk factors | 5 | 6 | 11 |
| 4 risk factors | 1 | 1 | 2 |
| Baseline HbA1c(Percentage) | Dexmedetomidine | 0.9% Sodium-chloride | Total |
|---|---|---|---|
| Mean | 5.4 ± 0.2 | 5.4 ± 0.4 | 5.4 ± 0.3 |
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Pontificia Universidad Catolica de Chile