NCT03809182

Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

Completed Phase 4 Results posted Last updated 1 October 2020

What this trial tests

Phase 4 trial testing Dexmedetomidine in Bariatric Surgery Candidate in 40 participants. Completed in 25 July 2013.

Timeline

27 September 2012

Primary endpoint
25 July 2013

25 July 2013

Quick facts

Lead sponsor	Pontificia Universidad Catolica de Chile
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	27 September 2012
Primary completion	25 July 2013
Estimated completion	25 July 2013

Drugs / interventions tested

• Dexmedetomidine (dexmedetomidine) — full drug profile →
• 0.9% Sodium-chloride
• Fentanyl (fentanyl) — full drug profile →
• Morphine Sulfate — full drug profile →

Conditions studied

• Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →
• Glucose Intolerance — all drugs for Glucose Intolerance →
• Insulin Resistance — all drugs for Insulin Resistance →

Sponsor

Pontificia Universidad Catolica de Chile — full company profile →

Who can join

Adults 18 to 60, any sex, with Bariatric Surgery Candidate or Glucose Intolerance. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Plasmatic Glucose Levels (mg/dl). Primary · 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.

Baseline level (T0)

Group	Value	95% CI
Dexmedetomidine	80	± 15
0.9% Sodium-chloride	82	± 8

Hour 2 (T1)

Group	Value	95% CI
Dexmedetomidine	114	± 29
0.9% Sodium-chloride	111	± 20

Hour 4 (T2)

Group	Value	95% CI
Dexmedetomidine	124	± 25
0.9% Sodium-chloride	129	± 17

Hour 6 (T3)

Group	Value	95% CI
Dexmedetomidine	131	± 60
0.9% Sodium-chloride	120	± 16

Hour 8 (T4)

Group	Value	95% CI
Dexmedetomidine	122	± 41
0.9% Sodium-chloride	118	± 17

Hour 10 (T5)

Group	Value	95% CI
Dexmedetomidine	130	± 62
0.9% Sodium-chloride	117	± 18

Hour 12 (T6)

Group	Value	95% CI
Dexmedetomidine	125	± 31
0.9% Sodium-chloride	117	± 17

Plasmatic Insulin Levels (uU/ml). Primary · 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.

Baseline level (T0)

Group	Value	95% CI
Dexmedetomidine	10.5	± 6
0.9% Sodium-chloride	11.2	± 6

Hour 2 (T1)

Group	Value	95% CI
Dexmedetomidine	11.8	± 9
0.9% Sodium-chloride	19.9	± 11.8

Hour 4 (T2)

Group	Value	95% CI
Dexmedetomidine	16.7	± 9.5
0.9% Sodium-chloride	30.3	± 19.9

Hour 6 (T3)

Group	Value	95% CI
Dexmedetomidine	16.8	± 11.4
0.9% Sodium-chloride	23	± 11.4

Hour 8 (T4)

Group	Value	95% CI
Dexmedetomidine	16.6	± 8.9
0.9% Sodium-chloride	21.5	± 10.4

Hour 10 (T5)

Group	Value	95% CI
Dexmedetomidine	16	± 10
0.9% Sodium-chloride	24	± 17.7

Hour 12 (T6)

Group	Value	95% CI
Dexmedetomidine	16.6	± 9.2
0.9% Sodium-chloride	25.9	± 18.3

Fentanyl Consumption. Secondary · Since the beginning of anesthesia until the end of it, an average of one hour and a half.

Amount of fentanyl (ug/kg) intraoperatively administered.

Group	Value	95% CI
Dexmedetomidine	6.0	± 2.2
0.9% Sodium-chloride	7	± 2.4

Amount (mg) of Morphine Consumed. Secondary · At 24h postoperative hours.

Morphine consumption in the first 24 postoperative hours.

Group	Value	95% CI
Dexmedetomidine	26	± 14.4
0.9% Sodium-chloride	18.4	± 10.6

Pain Scores in the First 24 Postoperative Hours. Secondary · At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).

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.

Hour 2 (T1) Pain at rest

Group	Value	95% CI
Dexmedetomidine	0	0 – 2
0.9% Sodium-chloride	0	0 – 4

Hour 2 (T1) Pain at movement

Group	Value	95% CI
Dexmedetomidine	0	0 – 2
0.9% Sodium-chloride	0	0 – 5

Hour 4 (T2) Pain at rest

Group	Value	95% CI
Dexmedetomidine	4	2 – 5
0.9% Sodium-chloride	3	2 – 4

Hour 4 (T2) Pain at movement

Group	Value	95% CI
Dexmedetomidine	5	4 – 6
0.9% Sodium-chloride	4	3 – 6

Hour 6 (T3) Pain at rest

Group	Value	95% CI
Dexmedetomidine	3	1 – 5
0.9% Sodium-chloride	2	2 – 3

Hour 6 (T3) Pain at movement

Group	Value	95% CI
Dexmedetomidine	4	2 – 6
0.9% Sodium-chloride	4	2 – 5

Hour 8 (T4) Pain at rest

Group	Value	95% CI
Dexmedetomidine	3	1 – 5
0.9% Sodium-chloride	1	0 – 3

Hour 8 (T4) Pain at movement

Group	Value	95% CI
Dexmedetomidine	4	3 – 7
0.9% Sodium-chloride	4	2 – 4

Sedation-agitation Scores in the First 12 Postoperative Hours. Secondary · At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).

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).

Hour 2 (T1)

Group	Value	95% CI
Dexmedetomidine	3	3 – 4
0.9% Sodium-chloride	4	4 – 4

Hour 4 (T2)

Group	Value	95% CI
Dexmedetomidine	4	3 – 4
0.9% Sodium-chloride	4	4 – 4

Hour 6 (T3)

Group	Value	95% CI
Dexmedetomidine	4	4 – 4
0.9% Sodium-chloride	4	4 – 4

Hour 8 (T4)

Group	Value	95% CI
Dexmedetomidine	4	4 – 4
0.9% Sodium-chloride	4	4 – 4

Hour 10 (T5)

Group	Value	95% CI
Dexmedetomidine	4	4 – 4
0.9% Sodium-chloride	4	4 – 4

Hour 12 (T6)

Group	Value	95% CI
Dexmedetomidine	4	4 – 4
0.9% Sodium-chloride	4	4 – 4

Postoperative Nausea and Vomiting. Secondary · Postoperative nausea and vomiting during the first 12 postoperative hours.

Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.

Group	Value	95% CI
Dexmedetomidine	16
0.9% Sodium-chloride	19

Adverse events — posted to ClinicalTrials.gov

Time frame: Intraop and 24 hours post-surgery.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dexmedetomidine

Serious: 0/20 (0%)

Deaths: 0/20

0.9% Sodium-chloride

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (3 terms — click to expand)

Reaction	System	Dexmedetomidine	0.9% Sodium-chloride
Hypotension associated with bradycardia	Cardiac disorders	—	—
Isolated Bradycardia	Cardiac disorders	—	—
Isolated hypotension	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT03809182 adverse events section.

Sponsor's own description

This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.