Effect of Dexmedetomidine on Postoperative Glucose and In... | NCT03809182

Effect of Dexmedetomidine on Postoperative Glucose and In... | NCT03809182 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Drug: 0.9% Sodium-chloride Drug: Fentanyl Drug: Morphine Sulfate

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.	Dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasmatic Glucose Levels (mg/dl).	Change of baseline glucose levels within the first 12 postoperative hours.	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.	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

Measure	Description	Time Frame
Fentanyl Consumption.	Amount of fentanyl (ug/kg) intraoperatively administered.	Since the beginning of anesthesia until the end of it, an average of one hour and a half.
Amount (mg) of Morphine Consumed.

Name	Affiliation	Role
Mauricio Ibacache, MD, PhD	Pontificia Universidad Catolica de Chile	Study Director

Arm/Group Information

ID	Title	Description
FG000	Dexmedetomidine	After anesthesia induction, patients who were randomized to the Dexmedetomidine group received: Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: 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 Sulfate: 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.
FG001	0.9% Sodium-chloride	After anesthesia induction, patients who were randomized to the Placebo group received: 0.9% Sodium-chloride: The same bolus and infusion rate used in the dexmedetomidine group. Fentanyl: 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 Sulfate: 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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00020 subjects FG00120 subjects
COMPLETED		FG00020 subjects FG00120 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Dexmedetomidine	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. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: Intraoperative fentanyl was given in the case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: 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 a patient-controlled analgesia pump was installed and the patient was discharged to his/her room.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Plasmatic Glucose Levels (mg/dl).

Change of baseline glucose levels within the first 12 postoperative hours.

All recruited population was analyzed.

Posted

Mean

Standard Deviation

mg/dl

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

ID	Title	Description
OG000	Dexmedetomidine	After anesthesia induction, patients who were randomized to the Dexmedetomidine group received: Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: 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 Sulfate: 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dexmedetomidine	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. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Isolated hypotension	Cardiac disorders		Systematic Assessment	Isolated hypotension

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Mauricio Ibacache MD	Pontificia Universidad Católica de Chile	+56984421425		mibacach@med.puc.cl

Condition Browse Module

ID	Term
D018149	Glucose Intolerance
D007333	Insulin Resistance

ID	Term
D006943	Hyperglycemia
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Intervention Browse Module

ID	Term
D020927	Dexmedetomidine
D012965	Sodium Chloride
D000077330	Saline Solution
D005283	Fentanyl
D009020	Morphine

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ASA physical status II

ASA I A normal healthy patient, ASA II A patient with mild systemic disease, ASA III A patient with severe systemic disease, ASA IV A patient with severe systemic disease that is a constant threat to life, ASA V A moribund patient who is not expected to survive without the operation, ASA VI A declared brain-dead patient whose organs are being removed for donor purposes

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00020 BG00120 BG00240

Risk score for postoperative nausea and vomiting (PONV) in adults

This corresponds to the Apfel simplified risk score, which is based on 4 predictors: female sex, history of PONV and/or motion sickness, nonsmoking status, and use of postoperative opioids. The higher the number of risk factors the more probable the incidence of PONV.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
0 risk factor	BG0000 BG0010 BG0020
1 risk factor	BG0000 BG0014 BG0024
2 risk factors	BG00014 BG0019 BG00223
3 risk factors	BG0005 BG0016 BG00211
4 risk factors	BG0001 BG0011 BG0022

Title

Denominators

Categories

Baseline level (T0)

Title	Measurements
	OG00080± 15 OG00182± 8

Hour 2 (T1)

Title	Measurements
	OG000114± 29 OG001111± 20

Hour 4 (T2)

Title	Measurements
	OG000124± 25 OG001129± 17

Hour 6 (T3)

Title	Measurements
	OG000131± 60 OG001120± 16

Hour 8 (T4)

Title	Measurements
	OG000122± 41 OG001118± 17

Hour 10 (T5)

Title	Measurements
	OG000130± 62 OG001117± 18

Hour 12 (T6)

Title	Measurements
	OG000125± 31 OG001117± 17

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis: There is no difference in plasmatic glucose levels between dexmedetomidine and 0.9% sodium-chloride groups.	Mixed Models Analysis		0.38	A p-value less than .05 was considered statistically significant.					2-Sided	95							Superiority

Primary

Plasmatic Insulin Levels (uU/ml).

Change of baseline insulin levels within the first 12 postoperative hours.

Posted

Mean

Standard Deviation

uU/dl

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

ID	Title	Description
OG000	Dexmedetomidine	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 case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
OG001	0.9% Sodium-chloride	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 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: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Baseline level (T0)

Title	Measurements
	OG00010.5± 6 OG00111.2± 6

Hour 2 (T1)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis: There is no difference in insulin levels between dexmedetomidine and 0.9% sodium-chloride groups.	Mixed Models Analysis		0.02	A p-value less than .05 was considered statistically significant.													Superiority

Secondary

Fentanyl Consumption.

Amount of fentanyl (ug/kg) intraoperatively administered.

Posted

Mean

Standard Deviation

mcg/kg

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

ID	Title	Description
OG000	Dexmedetomidine	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 case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
OG001	0.9% Sodium-chloride	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 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: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Title	Measurements
	OG0006.0± 2.2 OG0017± 2.4

Secondary

Amount (mg) of Morphine Consumed.

Morphine consumption in the first 24 postoperative hours.

Posted

Mean

Standard Deviation

At 24h postoperative hours.

ID	Title	Description
OG000	Dexmedetomidine	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 case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
OG001	0.9% Sodium-chloride	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 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: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Title	Measurements
	OG00026± 14.4 OG00118.4± 10.6

Secondary

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.

Posted

Median

Inter-Quartile Range

units on a scale

At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).

ID	Title	Description
OG000	Dexmedetomidine	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 case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
OG001	0.9% Sodium-chloride	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 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: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Hour 2 (T1) Pain at rest

Title	Measurements
	OG0000(0 to 2) OG0010(0 to 4)

Hour 2 (T1) Pain at movement

Title	Measurements
	OG000

Secondary

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).

Posted

Median

Inter-Quartile Range

score on a scale

At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).

ID	Title	Description
OG000	Dexmedetomidine	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 case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
OG001	0.9% Sodium-chloride	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 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: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Hour 2 (T1)

Title	Measurements
	OG0003(3 to 4) OG0014(4 to 4)

Hour 4 (T2)

Title	Measurements
	OG000

Secondary

Postoperative Nausea and Vomiting.

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

Posted

Count of Participants

Participants

Postoperative nausea and vomiting during the first 12 postoperative hours.

ID	Title	Description
OG000	Dexmedetomidine	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 case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
OG001	0.9% Sodium-chloride	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 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: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: 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 Sulfate: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Title	Measurements
	OG00016 OG00119