Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery

• Sponsor: NorthShore University HealthSystem (Other)
• Overall Status: Completed
• CT.gov ID: NCT01545700
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 6
• Duration (Months): 38
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

The question of a possible hyperglycemic effect from single-dose dexamethasone is an important issue for clinicians managing patients in the intraoperative and postoperative periods. Recent evidence suggests that even moderate elevations in blood glucose levels may be associated with adverse events.

The aim of this clinical investigation is to determine whether standard clinical doses of dexamethasone produce hyperglycemia in the perioperative period.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Complications	Drug: Control-saline; Drug: Dexamethasone 4 mg; Drug: Dexamethasone 8 mg; Drug: Control saline; Drug: Dexamethasone 4 mg; Drug: Dexamethasone 8 mg	Phase 4

Detailed Description

Patients will be randomized on the morning of surgery to one of six groups; dexamethasone 4mg groups (0-4 hour group, 8-24 hour group), dexamethasone 8 mg groups (0-4 hour group, 8-24 hour group), or a placebo group(0-4 hour group, 8-24 hour group). Randomization will be performed using the sealed envelope method (on the basis of a block-randomized computer-generated list). The drug/placebo solution will be prepared by the pharmacy into a syringe (either 2cc of dexamethasone (8mg), 1cc dexamethasone (4mg) + 1cc normal saline, or 2cc of saline (placebo)) and delivered to one of investigators. All solutions are clear and appear identical. Patients in the dexamethasone groups will receive a standard intraoperative dose of dexamethasone (either 4mg or 8 mg) intravenously at the induction of anesthesia. Patients in the placebo groups will receive 2 cc of saline at induction of anesthesia. Study syringes will be prepared by the pharmacy, and all clinicians will be blinded to group assignment.

Primary Outcome Variable Serum Glucose levels: In the 0-4 hour patients, Blood glucose concentrations will be measured at 5 time intervals: at induction of anesthesia and at 60, 120, 180, and 240 minutes after the dexamethasone is administered. In the 8-24 hour patients, blood glucose levels will be measured at induction of anesthesia and at at 8- and 24-hours after induction. All blood samples will be measured using a portable glucometer which is calibrated daily. Blood glucose will be calculated by measuring a fingerprick capillary blood sample. The blood samples will be collected while the patient is under anesthesia and recovering from surgery.

Secondary Outcome Variables

1. Pain scores: Postoperative pain scores will be assessed using 100 mm visual analog scale (VAS) in which 0 represents no pain and 100 represents the worst pain imaginable. Pain scores will be measured at rest and with movement at 1 and 2 hours following surgery.

2. Nausea and vomiting scores: The incidence of nausea will be quantified using a verbal rating scale (VRS- 0=no nausea, 1=mild nausea, 2=moderate nausea, 3=severe nausea). The incidence of vomiting was quantified on a 4-point scale; 0 = (none) no episodes, 1= (mild) 1 episode, 2= (moderate) 2-3 episodes, 3= (severe) more than 3 episodes. Nausea and vomiting scores will be obtained at discharge from the PACU.

3. PACU data: Episodes of nausea and vomiting will be recorded. Requirements for pain medication and antiemetic medication will be recorded. The time needed to meet discharge criteria and achieve actual discharge will be noted.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control, saline 0-4 hours 2 cc of saline	Drug: Control-saline; Patients are randomized to receive saline 2 cc
Active Comparator: Dexamethasone 4 mg, 0-4 hours Dexamethasone 4 mg administered intraoperatively	Drug: Dexamethasone 4 mg; Patients randomized to receive dexamethasone 4mg and 1 cc saline
Active Comparator: Dexamethasone 8 mg, 0-4 hours Dexamethasone 8 mg administered intraoperatively	Drug: Dexamethasone 8 mg; Patients randomized to receive dexamethasone 8mg
Placebo Comparator: Placebo Comparator saline 8-24 hours placebo, 2 cc saline	Drug: Control saline; Patients are randomized to receive saline 2 cc
Active Comparator: Dexamethasone 4 mg, 8-24 hours Dexamethasone 4 mg administered intraoperatively	Drug: Dexamethasone 4 mg; Patients are randomized to receive dexamethasone 4 mg and saline 1 cc
Active Comparator: Dexamethasone 8 mg, 8-24 hours Dexamethasone 8 mg administered intraoperatively	Drug: Dexamethasone 8 mg; Patients are randomized to receive dexamethasone 8 mg

Outcome Measures

Primary Outcome Measures

1. Serum Blood Glucose Concentrations [Patient were followed for the duration of hospitalization, for an average of 6 days]

   Serum blood glucose concentrations

Secondary Outcome Measures

1. Pain Scores [Patients were followed for the duration of hospitalization, for an average of 6 days]

   VAS pain scoes at rest 0=no pain, 100=worst pain imaginable

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients presenting for elective gynecologic surgery

Exclusion Criteria:

• Age < 18 or > 90, patients receiving chronic or preoperative steroids,or allergy to dexamethasone.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NorthShore University HealthSystem	Evanston	Illinois	United States	60201

Sponsors and Collaborators

• NorthShore University HealthSystem

Investigators

• Principal Investigator: Glenn S Murphy, MD, NorthShore University HealthSystem

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Glenn Murphy, Director, Cardiac Anesthesia and Clinical Research, NorthShore University HealthSystem
• ClinicalTrials.gov Identifier: NCT01545700
• Other Study ID Numbers: EH08-413
• First Posted: Mar 7, 2012
• Last Update Posted: Sep 30, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Glenn Murphy, Director, Cardiac Anesthesia and Clinical Research, NorthShore University HealthSystem: dexamethasone; hyperglycemia; gynecologic surgery
• Additional relevant MeSH terms: Hyperglycemia; Postoperative Complications; Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

Participant Flow

Recruitment Details	This study was conducted at NorthShore University HealthSystem (a single tertiary medical center affiliated with the University of Chicago Pritzker School of Medicine) and was registered with ClinicalTrials.gov (NCT #01545700). Participants were recruited by reviewing operating room schedules and contact by telephone on the day before surgery.
Pre-assignment Detail	A total of 200 patients were enrolled in this clinical trial.

Arm/Group Title	Control, Saline 0-4 Hours	Dexamethasone 4 mg, 0-4 Hours	Dexamethasone 8 mg, 0-4 Hours	Placebo Comparator Saline 8-24 Hours	Dexamethasone 4 mg, 8-24 Hours	Dexamethasone 8 mg, 8-24 Hours
Arm/Group Description	2 cc of saline Control-saline : Patients are randomized to receive saline 2 cc	Dexamethasone 4 mg administered intraoperatively Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline	Dexamethasone 8 mg administered intraoperatively Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg	placebo, 2 cc saline Control saline : Patients are randomized to receive saline 2 cc	Dexamethasone 4 mg administered intraoperatively Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc	Dexamethasone 8 mg administered intraoperatively Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg
Period Title: Overall Study
STARTED	34	33	33	34	33	33
COMPLETED	33	32	31	34	32	33
NOT COMPLETED	1	1	2	0	1	0

Baseline Characteristics

Arm/Group Title	Control, Saline 0-4 Hours	Dexamethasone 4 mg, 0-4 Hours	Dexamethasone 8 mg, 0-4 Hours	Placebo Comparator Saline 8-24 Hours	Dexamethasone 4 mg, 8-24 Hours	Dexamethasone 8 mg, 8-24 Hours	Total
Arm/Group Description	2 cc of saline Control-saline : Patients are randomized to receive saline 2 cc	Dexamethasone 4 mg administered intraoperatively Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline	Dexamethasone 8 mg administered intraoperatively Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg	placebo, 2 cc saline Control saline : Patients are randomized to receive saline 2 cc	Dexamethasone 4 mg administered intraoperatively Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc	Dexamethasone 8 mg administered intraoperatively Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg	Total of all reporting groups
Overall Participants	34	33	33	34	33	33	200
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	29 85.3%	29 87.9%	30 90.9%	25 73.5%	28 84.8%	28 84.8%	169 84.5%
>=65 years	5 14.7%	4 12.1%	3 9.1%	9 26.5%	5 15.2%	5 15.2%	31 15.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (10)	53 (9)	53 (11)	57 (12)	53 (13)	56 (11)	54 (9)
Sex: Female, Male (Count of Participants)
Female	34 100%	33 100%	33 100%	34 100%	33 100%	33 100%	200 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	34 100%	33 100%	33 100%	34 100%	33 100%	33 100%	200 100%

Outcome Measures

1. Secondary Outcome

Title	Pain Scores
Description	VAS pain scoes at rest 0=no pain, 100=worst pain imaginable
Time Frame	Patients were followed for the duration of hospitalization, for an average of 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo 0-4 Hours	Dexamethasone 4 mg 0-4 Hours	Dexamethasone 8 mg 0-4 Hours	Placebo 8-24 Hours	Dexamethasone 4 mg 8-24 Hours	Dexamethasone 8 mg 8-24 Hours
Arm/Group Description	Placebo 0-4 hours baseline
Measure Participants	33	32	31	34	32	33
Mean (Standard Deviation) [0-100 VAS scale scores on a scale]	50 (21)	47 (26)	45 (24)	50 (21)	45 (17)	44.5 (23)

2. Primary Outcome

Title	Serum Blood Glucose Concentrations
Description	Serum blood glucose concentrations
Time Frame	Patient were followed for the duration of hospitalization, for an average of 6 days

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	Placebo 0-4 Hours-baseline	Placebo 0-4 Hours-1 Hour	Placebo 0-4 Hours-2 Hours	Placebo 0-4 Hours-3 Hours	Placebo 0-4 Hours-4 Hours	Dexamethasone 4 mg 0-4 Hours-baseline	Dexamethasone 4 mg 0-4 Hours-1 Hour	Dexamethasone 4 mg 0-4 Hours-2 Hours	Dexamethasone 4 mg 0-4 Hours-3 Hours	Dexamethasone 4 mg 0-4 Hours-4 Hours	Dexamethasone 8 mg 0-4 Hours-baseline	Dexamethasone 8 mg 0-4 Hours-1 Hour	Dexamethasone 8 mg 0-4 Hours-2 Hours	Dexamethasone 8 mg 0-4 Hours-3 Hours	Dexamethasone 8 mg 0-4 Hours-4 Hours	Placebo 8-24 Hours Baseline	Placebo 8-24 Hours-8 Hours	Placebo 8-24 Hours-24 Hours	Dexamethasone 4 mg 8-24 Hours-baseline	Dexamethasone 4 mg 8-24 Hours-8 Hours	Dexamethasone 4 mg 8-24 Hours-24 Hours	Dexamethasone 8 mg 8-24 Hours-baseline	Dexamethasone 8 mg 8-24 Hours-8 Hours	Dexamethasone 8 mg 8-24 Hours-24 Hours
Arm/Group Description	Placebo 0-4 hours baseline	Placebo 0-4 hours-1 hour	Placebo 0-4 hours-2 hours
Measure Participants	34	33	33	33	33	32	32	32	32	32	31	31	31	31	31	34	34	34	32	32	32	33	33	33
Mean (Standard Deviation) [mg/dl]	101 (15)	137 (29)	140 (28)	141 (34)	139 (34)	107 (21)	141 (23)	159 (33)	159 (30)	159 (25)	108 (23)	138 (27)	151 (23)	146 (22)	149 (25)	101 (19)	150 (36)	121 (26)	98 (16)	149 (28)	119 (16)	100 (19)	151 (36)	124 (27)

Adverse Events

Arm/Group Title	Control-saline Group		Dexamethasone Group
Arm/Group Description	either 4 mg or 8 mg
All Cause Mortality
	Control-saline Group		Dexamethasone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control-saline Group		Dexamethasone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/128 (0%)
Other (Not Including Serious) Adverse Events
	Control-saline Group		Dexamethasone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/128 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.