Comparison of Aprepitant Versus Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

• Sponsor: Drexel University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00717054
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 115
• Location: 1
• Arms: 2
• Duration (Months): 24.9
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for post-operative nausea and vomiting (PONV) treated with oral aprepitant with or without transdermal scopolamine preoperatively.

Condition or Disease	Intervention/Treatment	Phase
Nausea; Vomiting	Drug: Aprepitant; Drug: Scopolamine	N/A

Detailed Description

Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P. NK-1 receptors are found on vagal afferents in the gastrointestinal tract and in the nucleus tractus solitaries in the brain. Substance P action on the NK-1 receptors in the central nervous system (CNS) is one of the final pathways to an emetic response.

Scopolamine antagonizes muscarinic type 1 (M1) and histamine type 1 (H1) receptors in the CNS, hypothalamus, and vomiting center. The noradrenergic system is also suppressed resulting in a diminished response to vestibular stimulation. Surgical procedures, opioids, and movement postoperatively all stimulate the vestibular system making scopolamine effective prophylaxis for PONV.

In adults undergoing general anesthesia with inhalational anesthetic agents, predictive risk factors for PONV include female sex, history of PONV or motion sickness, nonsmoking status, and the use of postoperative opioids. The frequency of PONV is 10% with zero, 21% with one, 39% with two, 61% with three, and 79% with 4 risk factors. The type of surgery also plays a major role. High risk procedures include intrabdominal, laparoscopic, orthopedic, major gynecologic, thyroid, otolaryngological, neurosurgical, breast, and plastic surgery.

Improving PONV prophylaxis would have a profound impact on patient care. Decreasing the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned admissions is beneficial. Recent evidence suggests multiple drug therapy is superior to single agents. The correct preoperative treatment medication is instrumental in the outcome. This study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine preoperatively.

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind Comparison of Oral Aprepitant Alone vs Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aprepitant and Scopolamine group Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.	Drug: Aprepitant; Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia; Other Names: Emend ; Drug: Scopolamine; Scopolamine transdermal applied to skin behind the ear one hour prior to surgery; Other Names: Scopace Transdermal scopolamine
Placebo Comparator: Aprepitant and Scopolamine Placebo Group Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.	Drug: Scopolamine; Scopolamine transdermal applied to skin behind the ear one hour prior to surgery; Other Names: Scopace Transdermal scopolamine

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Nausea and Vomiting [24 hours postoperatively]

Secondary Outcome Measures

1. Number of Participants With Nausea and Vomiting in PACU [Postoperatively, up to 2 hours]

2. Total Vomiting [24 hours postoperatively]

3. Need for Antiemetic Medication [24 hours postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Between 18 and 65 years of age

• American Society of Anesthesiology (ASA) physical status 1-3

• If on oral contraceptive, must be willing to use back up method for 1 month

• Must have 2 risk factors for PONV

Exclusion Criteria:

• History of vomiting due to middle ear infection, nervous system disorder, or other condition

• Procedure less than 1 hour

• Pregnant or breast feeding

• Antiemetic medication in previous 24 hours

• Narrow-angle glaucoma

• Allergic to belladonna alkaloids

• Hypersensitive to barbiturates

• Prostate hypertrophy

• Severe hepatic disease

• On chemotherapy taking aprepitant

• Fever

• Sepsis

• Taking any of the following medications: Orap, Seldane, Hismanal, Propulsid, Phenytoin, Phenothiazines, Tricyclic antidepressants, Meperidine, Tolbutamide, Aluminum and Magnesium containing Antacids, Anti-cholinergics, Coumadin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hahnemann University Hospital	Philadelphia	Pennsylvania	United States	19102

Sponsors and Collaborators

• Drexel University
• Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: Michael S Green, DO, Drexel University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Drexel University
• ClinicalTrials.gov Identifier: NCT00717054
• Other Study ID Numbers: 00659737
• First Posted: Jul 16, 2008
• Last Update Posted: May 20, 2014
• Last Verified: Sep 1, 2013

• Keywords provided by Drexel University: postoperative nausea and vomiting
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Scopolamine; Aprepitant; Butylscopolammonium Bromide

Study Results

Participant Flow

Arm/Group Title	Aprepitant and Scopolamine Group	Aprepitant and Placebo Scopolamine Group
Arm/Group Description	Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Period Title: Overall Study
STARTED	58	57
COMPLETED	58	57
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Aprepitant and Scopolamine Group	Aprepitant and Placebo Scopolamine Group	Total
Arm/Group Description	Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Total of all reporting groups
Overall Participants	58	57	115
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.3 (11.06)	47.2 (11.27)	46.8 (11.17)
Sex: Female, Male (Count of Participants)
Female	51 87.9%	52 91.2%	103 89.6%
Male	7 12.1%	5 8.8%	12 10.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Nausea and Vomiting
Time Frame	24 hours postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant and Scopolamine Group	Aprepitant and Placebo Scopolamine Group
Arm/Group Description	Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Measure Participants	58	57
Number [participants]	24 41.4%	29 50.9%

2. Secondary Outcome

Title	Number of Participants With Nausea and Vomiting in PACU
Time Frame	Postoperatively, up to 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant and Scopolamine Group	Aprepitant and Placebo Scopolamine Group
Arm/Group Description	Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Measure Participants	58	57
Number [participants]	35 60.3%	39 68.4%

3. Secondary Outcome

Title	Total Vomiting
Time Frame	24 hours postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant and Scopolamine Group	Aprepitant and Scopolamine Placebo Group
Arm/Group Description	Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Measure Participants	58	57
Number [participants]	5 8.6%	2 3.5%

4. Secondary Outcome

Title	Need for Antiemetic Medication
Time Frame	24 hours postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant and Scopolamine Group	Aprepitant and Scopolamine Placebo Group
Arm/Group Description	Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Measure Participants	58	57
Number [participants]	23 39.7%	21 36.8%

Adverse Events

Time Frame	1 year
Arm/Group Title	Aprepitant and Scopolamine Group		Aprepitant and Scopolamine Placebo Group
Arm/Group Description	Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery		Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
All Cause Mortality
	Aprepitant and Scopolamine Group		Aprepitant and Scopolamine Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Aprepitant and Scopolamine Group		Aprepitant and Scopolamine Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Aprepitant and Scopolamine Group		Aprepitant and Scopolamine Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/58 (58.6%)		29/57 (50.9%)
General disorders
Dry mouth	34/58 (58.6%)	34	29/57 (50.9%)	29

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.