Study of Nicotine for the Prevention of PONV | NCT00553709

Studies
Study of Nicotine for the Prevention of PONV

NCT00553709

Sponsor

University Hospital, Geneva

Status

Terminated

Last Update Posted

Sep 29, 2009Estimated

Enrollment

200Estimated

Phase

Phase 2

Conditions

Postoperative Nausea and Vomiting

Interventions

Nicotine

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
APSIC 04-010

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unexpected difficult recruitment. Study drug expired

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Nov 2, 2007

First Submission Date that Met QC Criteria

Nov 2, 2007

First Posted Date

Nov 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2009

Last Update Posted Date

Sep 29, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether nicotine is effective in the prevention of nausea and vomiting in non-smokers undergoing surgery

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nicotine patch	Experimental	Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10)	Drug: Nicotine
Placebo patch	Placebo Comparator	Placebo patch 10 cm2	Drug: Nicotine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nicotine	Drug	Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10)	Nicotine patch Placebo patch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevention of PONV		48 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Adverse effects that may be related to the nicotine patch, for instance, local skin reaction.		48 hours postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults (18-80 years)
ASA I-II, non-smokers (or ex-smokers who have not been smoking for more than 2 years)
Undergoing elective surgery (ENT, abdominal, urological, gynaecological); and
Consenting to take part in the study will be included.

Exclusion Criteria:

Smokers (cigarette, pipe, cigar)
Patients undergoing nicotine replacement therapy
Prolonged postoperative intubation
Postoperative nasogastric tube

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin R Tramèr, MD, DPhil	University Hospital, Geneva	Study Chair
Daniel Bertrand, PhD	Medical Faculty, Geneva University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Anesthesiology, Geneva University Hospitals		Geneva	Canton of Geneva	CH-1211	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting
D009325	Nausea
D014839	Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012817	Signs and Symptoms, Digestive

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009538	Nicotine

Ancestor Terms

ID	Term
D012991	Solanaceous Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D011725	Pyridines

Browse Leaves

Not provided

Browse Branches

Not provided