Therapeutic Equivalence Study of Propofol Compared with Diprivan® in Patients Undergoing Elective Surgery

Phase 1

• Conditions: MedDRA version: 18.0Level: PTClassification code 10042609Term: SurgerySystem Organ Class: 10042613 - Surgical and medical procedures; Elective minor Surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-005701-43-FR
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-02-13
• Study Start: 2015-06-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

1. Male or female subjects =18 years and <65 years old
2. Able to understand and give signed and dated written informed consent
3. Body mass index (BMI) =20 and =30 kg/m2 at screening
4. ASA physical status 1 or 2
5. Undergoing elective, minor orthopaedic, vascular, urological, or gynaecological surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The following planned procedures are to be excluded:
- Day surgery
- Emergency surgery
- Total hip or total knee replacement
- Requiring opening of the great cavities of the body (cranium, thorax, peritoneum, or pelvis)
- With routine risk, even if low, of haemorrhage severe enough to require administration or colloid or blood products
- With routine risk, even if low, of death during or soon after the procedure
- Vascular surgery involving the aorta, venae cavae, iliac arteries, or femoral arteries
2. Intended administration of IV medications through a central venous catheter
3. Administration of general anaesthesia or propofol within the 7 days prior to randomisation
4. History of hypersensitivity to propofol, eggs, Soya, peanuts, or any other constituent of the study drugs
5. ASA physical status =3
6. History of major anaesthesia complications
7. History of difficult airway management
8. History of difficult venous access
9. Myocardial infarction within 6 months of randomisation or a cardiac reperfusion procedure within 6 weeks of randomisation
10. Significant respiratory, cardiovascular, liver or renal disease as assessed by Investigator
11. Active systemic infection (localised infection related to surgical procedure is allowable as long as there is no indication of systemic involvement)
12. History of psychiatric disorder, including use of sedatives or antidepressants for any reason, within 6 months prior to randomisation
13. Alcohol or other substance abuse within 2 years prior to randomisation, as well as for the duration of the study
14. Use of medication that could reduce the subject’s respiratory and cardiac output

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified