RecruitingPhase 4NCT06951802

Endometriosis and Pain Treatment by Intraoperative Administration of Low-dose Ketamine

Endometriosis and Pain Treatment by Intraoperative Administration of Low-dose Ketamine A Single-Centre, Prospective, Randomized, Controlled Trial


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

118 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

RCT comparing intraoperative administration of low-dose ketamine during laparoscopic endometriosis operation and the postoperative pain outcome


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria13

  • 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

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Interventions

DRUGKetamine

Low-dose administration of ketamine during laparoscopic surgery

DRUGPropofol

Control group


Locations(1)

Inselspital Bern

Bern, Switzerland

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NCT06951802


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