Status:
RECRUITING
Endometriosis and Pain Treatment by Intraoperative Administration of Low-dose Ketamine
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Endometriosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
RCT comparing intraoperative administration of low-dose ketamine during laparoscopic endometriosis operation and the postoperative pain outcome
Detailed Description
Endometriosis affects 10% of women of childbearing age and 25% - 50% of infertile women worldwide. Although most patients with endometriosis are completely asymptomatic, there are still a significant ...
Eligibility Criteria
Inclusion
- Patients undergoing surgery for endometriosis operation requiring general anaesthesia at the Inselspital, Bern University Hospital, University of Bern, Department of gynaecology and obstetrics.
- Age ≥ 18 years
- American Society of Anesthesiologist (ASA) physical status 1-3
- Patients with known or suspected endometriosis
- Written informed consent.
Exclusion
- Age \< 18 years
- ASA physical status ≥4
- Higher-grade atrioventricular block without pacemaker
- Severe hypovolemia or bradycardia
- Uncontrolled hyper- or hypotension
- Liver disease
- Known malignant hyperthermia
- Cardiovascular instability or severe heart failure (New York Heart Association classification (NYHA) \> III)
- Myocardial infarction during the last 30 days prior to surgery
- Increased intracranial or increased intraocular pressure
- Limited peripheral autonomic activity, hypersensitivity to ketamine or propofol or its components
- Pregnancy
- Rejection or lack of consent of the patient or relatives
Key Trial Info
Start Date :
December 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06951802
Start Date
December 3 2024
End Date
December 31 2026
Last Update
April 30 2025
Active Locations (1)
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1
Inselspital Bern
Bern, Switzerland, 3010