Evaluation of 2 Doses of Intravenous Droperidol in the Pr... | NCT00445055

Studies
Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea

NCT00445055

Sponsor

University Hospital, Bordeaux

Status

Terminated

Last Update Posted

Dec 13, 2011Estimated

Enrollment

71Actual

Phase

Phase 4

Conditions

Nausea
Vomiting

Interventions

Droperidol

Countries

France

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

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Mar 6, 2007

First Submission Date that Met QC Criteria

Mar 7, 2007

First Posted Date

Mar 8, 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

Dec 12, 2011

Last Update Posted Date

Dec 13, 2011Estimated

Name	Class
Kyowa Kirin Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

In this prospective, randomised, placebo-controlled study, the researchers determined whether 0.625 mg or 2.5 mg of IV droperidol given 30 min before emergence from general anaesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in thyroid surgical female population. Two hundred and forty six female patients receiving general anaesthesia for thyroid surgery received either droperidol 0.625 mg or droperidol 2.5 mg or placebo before emergence.

Detailed Description

Principal Objective : Our study examined one main question: Are there difference in efficacy between droperidol IV 0.625 mg or 2.5 mg for the treatment or prophylaxis of PONV to surgical patient undergoing thyroid surgery when they receive it 30 min before emergence from general anaesthesia?
Secondary Objective :
- comparison of the % of patients in every group:
  - having a complete control of their nausea
  - requiring secondarily the appeal to another anti-emetic treatment in postoperative
  - presenting an Adverse event
- Compare score of sedation in ach groups
- Evaluate electrocardiograph
- Compare the morphine consumption
Study design : Prospective, randomized, monocenter, double-blind study
Inclusion criteria :
- Female
- More than 18 years old
- Patients scheduled for thyroid surgery
- Simplified Apfel score ≥ 2
- ASA score : 1-2
- Informed consent obtained from the patient
- the women in age of procreate must have a reliable contraceptive method
Exclusion criteria :
- age < 18 years old
- male
- obesity
- present a severe depressive syndrome
- pregnancy women
- trouble of cardiac rate
- alcoholism
- contra-indication for Droperidol prescription
Study plan: three parallel groups will receive 2 different doses of Droperidol or placebo at the end of surgery.
- Group 1: 0,625mg of Droperidol at the end of surgery
- Group 2: 2,5mg of Droperidol at the end of surgery
- Group 3: Placebo at the end of surgery
Number of subjects : 246

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Intravenous injection of 0,625 mg Droperidol, 30 min before the end of anesthesia	Drug: Droperidol
2	Experimental	Intravenous injection of 2,5 mg Droperidol, 30 min before the end of anesthesia	Drug: Droperidol
3	Placebo Comparator	Intravenous injection of NaCl 9% (Placebo), 30 min before the end of anesthesia	Drug: Droperidol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Droperidol	Drug	Intravenous injection	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
No vomiting episode		During the first four hours after intervention

Secondary Outcomes

Measure	Description	Time Frame
Light nausea		24h post operative
Control of nausea		24h post operative
Anti-vomiting treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
More than 18 years old
Patients scheduled for thyroid surgery
Simplified Apfel score ≥ 2
ASA score : 1-2
Informed consent obtained from the patient
Women able to procreate must have a reliable contraceptive method

Exclusion Criteria:

Age < 18 years old
Male
Obesity
Has a severe depressive syndrome
Pregnancy women
Trouble with cardiac rate
Alcoholism
Contra-indication for Droperidol prescription

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gérard JANVIER, MD	University Hospital, Bordeaux	Study Director
Laure BAUDOUIN, Dr	University Hospital, Bordeaux	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Département d'Anesthésie-Réanimation II ; Groupe Hospitalier Sud, CHU de Bordeaux		Pessac		33604	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10730546	Background	Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005.
8031342	Background	Williams OA, Clarke FL, Harris RW, Smith P, Peacock JE. Addition of droperidol to patient-controlled analgesia: effect on nausea and vomiting. Anaesthesia. 1993 Oct;48(10):881-4. doi: 10.1111/j.1365-2044.1993.tb07419.x.

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D002090	Butyrophenones
D007659	Ketones
D009930	Organic Chemicals
D001562	Benzimidazoles

ID	Term
D009325	Nausea
D014839	Vomiting