Postoperative ComplicationsPhase 4NCT01545700
Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
A Phase 4 study testing Dexamethasone 4 mg and Dexamethasone 8 mg in people with Postoperative Complications, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Dexamethasone 4 mg and Dexamethasone 8 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2012
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting for elective gynecologic surgery
Who cannot join
- Age < 18 or > 90, patients receiving chronic or preoperative steroids,or allergy to dexamethasone.
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
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.
Read the 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
- 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.
- 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.
- 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.
- Conditions
- Postoperative Complications
- Being tested
- Control-saline, Dexamethasone 4 mg, Dexamethasone 8 mg, Control saline
- Keywords
- dexamethasone, hyperglycemia, gynecologic surgery
- Medical subject headings
- Postoperative Complications, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control-salineDrug
Patients are randomized to receive saline 2 cc
Dexamethasone 4 mgDrug
Patients randomized to receive dexamethasone 4mg and 1 cc saline
Dexamethasone 8 mgDrug
Patients randomized to receive dexamethasone 8mg
Control salineDrug
Patients are randomized to receive saline 2 cc
Dexamethasone 4 mgDrug
Patients are randomized to receive dexamethasone 4 mg and saline 1 cc
Dexamethasone 8 mgDrug
Patients are randomized to receive dexamethasone 8 mg
| Study group | Role | What they receive |
|---|---|---|
| Control, saline 0-4 hours | Placebo comparator | 2 cc of saline Receives: Drug: Control-saline |
| Dexamethasone 4 mg, 0-4 hours | Active comparator | Dexamethasone 4 mg administered intraoperatively Receives: Drug: Dexamethasone 4 mg |
| Dexamethasone 8 mg, 0-4 hours | Active comparator | Dexamethasone 8 mg administered intraoperatively Receives: Drug: Dexamethasone 8 mg |
| Placebo Comparator saline 8-24 hours | Placebo comparator | placebo, 2 cc saline Receives: Drug: Control saline |
| Dexamethasone 4 mg, 8-24 hours | Active comparator | Dexamethasone 4 mg administered intraoperatively Receives: Drug: Dexamethasone 4 mg |
| Dexamethasone 8 mg, 8-24 hours | Active comparator | Dexamethasone 8 mg administered intraoperatively Receives: Drug: Dexamethasone 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Blood Glucose Concentrations
Serum blood glucose concentrations
Measured: Patient were followed for the duration of hospitalization, for an average of 6 days
Secondary outcomes (1)
Pain Scores
VAS pain scoes at rest 0=no pain, 100=worst pain imaginable
Measured: Patients were followed for the duration of hospitalization, for an average of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startSep 2009
- Primary completionNov 2012
- Study completionNov 2012
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 Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn Murphy, Endeavor Health
- Investigators
- Glenn S Murphy, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545700
- Sponsor's protocol ID
- EH08-413
- Status last verified
- Sep 2019
- First submitted
- 27 Feb 2012
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
- ClinicalTrials.gov ID
- NCT01545700
- Acronym / sponsor ID
- EH08-413
- Conditions
- Postoperative Complications
- Keywords
- dexamethasone, hyperglycemia, gynecologic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 15 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control, saline 0-4 hours | Placebo comparator | Drug: Control-saline2 cc of saline |
| Dexamethasone 4 mg, 0-4 hours | Active comparator | Drug: Dexamethasone 4 mgDexamethasone 4 mg administered intraoperatively |
| Dexamethasone 8 mg, 0-4 hours | Active comparator | Drug: Dexamethasone 8 mgDexamethasone 8 mg administered intraoperatively |
| Placebo Comparator saline 8-24 hours | Placebo comparator | Drug: Control salineplacebo, 2 cc saline |
| Dexamethasone 4 mg, 8-24 hours | Active comparator | Drug: Dexamethasone 4 mgDexamethasone 4 mg administered intraoperatively |
| Dexamethasone 8 mg, 8-24 hours | Active comparator | Drug: Dexamethasone 8 mgDexamethasone 8 mg administered intraoperatively |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting for elective gynecologic surgery
Key exclusion criteria (1 listed)
- Age < 18 or > 90, patients receiving chronic or preoperative steroids,or allergy to dexamethasone.
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 |
|---|---|---|
| Control-salinePatients are randomized to receive saline 2 cc | Drug | Control, saline 0-4 hours |
| Dexamethasone 4 mgPatients randomized to receive dexamethasone 4mg and 1 cc saline | Drug | Dexamethasone 4 mg, 0-4 hours |
| Dexamethasone 8 mgPatients randomized to receive dexamethasone 8mg | Drug | Dexamethasone 8 mg, 0-4 hours |
| Control salinePatients are randomized to receive saline 2 cc | Drug | Placebo Comparator saline 8-24 hours |
| Dexamethasone 4 mgPatients are randomized to receive dexamethasone 4 mg and saline 1 cc | Drug | Dexamethasone 4 mg, 8-24 hours |
| Dexamethasone 8 mgPatients are randomized to receive dexamethasone 8 mg | Drug | Dexamethasone 8 mg, 8-24 hours |
Primary outcome
Serum Blood Glucose Concentrations
Time frame: Patient were followed for the duration of hospitalization, for an average of 6 days
Serum blood glucose concentrations
1 secondary outcome
Pain Scores
Time frame: Patients were followed for the duration of hospitalization, for an average of 6 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Glenn S Murphy, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone 4 mg and Dexamethasone 8 mg in people with Postoperative Complications, run by Endeavor Health at 1 site in United States.
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 1 inclusion and 1 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 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 15 Jan 2013). 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?
Serum Blood Glucose Concentrations (time frame: Patient were followed for the duration of hospitalization, for an average of 6 days). 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 30 Sep 2019.