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Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.
Women having cesarean sections commonly experience post-operative nausea and vomiting (PONV). This can be partly attributed to the long acting morphine (duramorph) given in the anesthetic (either through the epidural or in the spinal anesthetic). Intravenous dexamethasone is a widely used steroid medication with a well-established safety profile which is the standard of care for the prevention of PONV for general anesthesia in both adult and pediatric surgical patients. Many studies have shown that when intravenous dexamethasone is administered before duramorph in the epidural, the incidence of nausea and vomiting following cesarean section is significantly reduced. However, when patients receive intravenous dexamethasone after duramorph in a spinal anesthetic, it does not reduce the incidence of nausea and vomiting. There are not any published studies where dexamethasone was administered before a spinal anesthetic. The investigators believe that if dexamethasone is given intravenously before duramorph in a spinal anesthetic it may reduce the incidence of nausea and vomiting. Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Active Comparator | One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes. |
|
| Placebo | Placebo Comparator | One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 8mg IV dexamethesone given |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post-operative Nausea and/or Vomiting | The patient's self report of nausea and incidence of vomiting will be recorded intra-operatively, upon arrival to the PACU and at 1, 3, 6, 24, and 48 hours after surgery | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Kjaer, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22344239 | Background | Allen TK, Jones CA, Habib AS. Dexamethasone for the prophylaxis of postoperative nausea and vomiting associated with neuraxial morphine administration: a systematic review and meta-analysis. Anesth Analg. 2012 Apr;114(4):813-22. doi: 10.1213/ANE.0b013e318247f628. Epub 2012 Feb 17. | |
| 23022704 | Background | Cardoso MM, Leite AO, Santos EA, Gozzani JL, Mathias LA. Effect of dexamethasone on prevention of postoperative nausea, vomiting and pain after caesarean section: a randomised, placebo-controlled, double-blind trial. Eur J Anaesthesiol. 2013 Mar;30(3):102-5. doi: 10.1097/EJA.0b013e328356676b. |
| Label | URL |
|---|---|
| Nausea and Vomiting | View source |
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No plan to share IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes. Dexamethasone: 8mg IV dexamethesone given |
| FG001 | Placebo | One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes. Placebo: Subjects randomized to placebo receive 50cc normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone | One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes. Dexamethasone: 8mg IV dexamethesone given |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence of Post-operative Nausea and/or Vomiting | The patient's self report of nausea and incidence of vomiting will be recorded intra-operatively, upon arrival to the PACU and at 1, 3, 6, 24, and 48 hours after surgery | Posted | Count of Participants | Participants | 48 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone | One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes. Dexamethasone: 8mg IV dexamethesone given |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | Systematic Assessment | Hypertension |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Klaus Kjaer, MD | Weill Cornell Medicine | (212) 746-2953 | klk9001@med.cornell.edu |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo | Drug | Subjects randomized to placebo receive 50cc normal saline |
|
|
| 22964805 | Background | Hamzei A, Basiri-Moghadam M, Pasban-Noghabi S. Effect of dexamethasone on incidence of headache after spinal anesthesia in cesarean section. A single blind randomized controlled trial. Saudi Med J. 2012 Sep;33(9):948-53. |
| 31989472 | Derived | Selzer A, Pryor KO, Tangel V, O'Connell K, Kjaer K. The effect of intravenous dexamethasone on postoperative nausea and vomiting after Cesarean delivery with intrathecal morphine: a randomized-controlled trial. Can J Anaesth. 2020 Jul;67(7):817-826. doi: 10.1007/s12630-020-01582-y. Epub 2020 Jan 27. |
| Drug information for Dexamethasone | View source |
One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Placebo: Subjects randomized to placebo receive 50cc normal saline
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 7 |
| 55 |
| EG001 | Placebo | One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes. Placebo: Subjects randomized to placebo receive 50cc normal saline | 0 | 53 | 0 | 53 | 3 | 53 |
| incision site bleeding | Surgical and medical procedures | Systematic Assessment | incision site bleeding |
|
| low body temperature | General disorders | Systematic Assessment | low body temperature |
|
| post-op shivering | General disorders | Systematic Assessment | post-op shivering |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment | Tachycardia |
|
| Transfusion Required | Vascular disorders | Non-systematic Assessment | Transfusion Required |
|
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| D012816 | Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |