Dexamethasone for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Cesarean Sections

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01734161
• Collaborator: (none)
• Enrollment: 122
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: Dexamethasone; Drug: Placebo	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Prospective, Randomized, Double-Blinded Study to Evaluate the Efficacy of Intravenous Dexamethasone for Nausea Prophylaxis Prior to Duramorph and Bupivacaine Spinal Anesthesia for Scheduled Cesarean Section
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexamethasone One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.	Drug: Dexamethasone; 8mg IV dexamethesone given; Other Names: Decadron
Placebo Comparator: Placebo One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.	Drug: Placebo; Subjects randomized to placebo receive 50cc normal saline; Other Names: 50 ml 0.9% saline

Outcome Measures

Primary Outcome Measures

1. Incidence of Post-operative Nausea and/or Vomiting [48 hours]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 46 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women aged 18-46 presenting for scheduled primary or repeat cesarean sections and have consented to study

Exclusion Criteria:

• allergy to dexamethasone or morphine

• history of gastrointestinal disease

• history of severe nausea during pregnancy (hyperemesis gravidarum)

• use of anti-emetic in the past 24 hours

• history of gestational diabetes or diabetes mellitus

• history of hypertension prior to or during pregnancy

• presence of non-viable fetus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Klaus Kjaer, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Nausea and Vomiting
• Drug information for Dexamethasone

Publications

• 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. Review.
• 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.
• 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.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT01734161
• Other Study ID Numbers: 1207012632
• First Posted: Nov 27, 2012
• Last Update Posted: Oct 15, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Weill Medical College of Cornell University: cesarean section; nausea; vomiting; dexamethasone; postoperative nausea and vomiting; antiemetics
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Dexamethasone

Study Results

Participant Flow

Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	61	61
COMPLETED	55	53
NOT COMPLETED	6	8

Baseline Characteristics

Arm/Group Title	Dexamethasone	Placebo	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	55	53	108
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.2 (5.2)	35.7 (3.7)	35.5 (4.5)
Sex: Female, Male (Count of Participants)
Female	55 100%	53 100%	108 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Incidence of Post-operative Nausea and/or Vomiting
Description	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
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description	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	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
Measure Participants	55	53
Count of Participants [Participants]	29 52.7%	24 45.3%

Adverse Events

Arm/Group Title	Dexamethasone		Placebo
Arm/Group Description	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		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
All Cause Mortality
	Dexamethasone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/53 (0%)
Serious Adverse Events
	Dexamethasone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	Dexamethasone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/55 (12.7%)		3/53 (5.7%)
Cardiac disorders
Tachycardia	1/55 (1.8%)	1	0/53 (0%)	1
General disorders
low body temperature	2/55 (3.6%)	2	0/53 (0%)	2
post-op shivering	1/55 (1.8%)	1	0/53 (0%)	1
Surgical and medical procedures
incision site bleeding	1/55 (1.8%)	1	0/53 (0%)	1
Vascular disorders
Hypertension	1/55 (1.8%)	1	3/53 (5.7%)	3
Transfusion Required	1/55 (1.8%)	1	0/53 (0%)	1

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.