Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00445055
Other study ID # CHUBX 2006/02
Secondary ID
Status Terminated
Phase Phase 4
First received March 6, 2007
Last updated December 12, 2011
Start date April 2007
Est. completion date April 2009

Study information

Verified date December 2011
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Terminated
Enrollment 71
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Droperidol
Intravenous injection

Locations

Country Name City State
France Département d'Anesthésie-Réanimation II ; Groupe Hospitalier Sud, CHU de Bordeaux PESSAC Cedex

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Bordeaux Prostrakan Pharmaceuticals

Country where clinical trial is conducted

France, 

References & Publications (5)

Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramèr MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. Review. — View Citation

Henzi I, Sonderegger J, Tramèr MR. Efficacy, dose-response, and adverse effects of droperidol for prevention of postoperative nausea and vomiting. Can J Anaesth. 2000 Jun;47(6):537-51. Review. — View Citation

Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. Review. — View Citation

Wang JJ, Ho ST, Lee SC, Liu YC, Liu YH, Liao YC. The prophylactic effect of dexamethasone on postoperative nausea and vomiting in women undergoing thyroidectomy: a comparison of droperidol with saline. Anesth Analg. 1999 Jul;89(1):200-3. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary No vomiting episode During the first four hours after intervention No
Secondary Light nausea 24h post operative No
Secondary Control of nausea 24h post operative No
Secondary Anti-vomiting treatment 24h post operative No
Secondary Adverse events 24h post operative Yes
Secondary Modification of electrocardiograph 30 min and 120 min after injection Yes
Secondary - Score of sedation 24h post operative Yes
See also
  Status Clinical Trial Phase
Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy Phase 1
Completed NCT02939287 - Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan Phase 3
Not yet recruiting NCT06464926 - Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE) N/A
Not yet recruiting NCT06055192 - Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022
Recruiting NCT04091789 - Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea Phase 2
Completed NCT02462811 - A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV) Phase 3
Completed NCT01007500 - Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery Phase 4
Recruiting NCT00528554 - Laser Acupuncture Against Nausea in Children N/A
Completed NCT00537875 - Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens N/A
Completed NCT00394966 - A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED) Phase 2
Completed NCT00946387 - To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions Phase 1
Completed NCT00947128 - To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions Phase 1
Recruiting NCT05433636 - Mindful Waiting Room N/A
Not yet recruiting NCT04827108 - Psychometric Properties of the Chinese Version of PeNAT
Not yet recruiting NCT04853303 - VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK N/A
Terminated NCT04247100 - A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders N/A
Recruiting NCT04181346 - Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting Phase 2
Recruiting NCT03679182 - Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care Phase 2
Completed NCT02618343 - EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron N/A
Terminated NCT01405924 - Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030) Phase 2