Combination of alpha2-adrenoreceptor agonists, opioids and ketamine for improving of perioperative course

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000043-10-CZ

Enrollment

360

Registered

2007-01-30

Start date

2007-01-30

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Praeanaesthetic preparation (premedication) for patients scheduled for laparoscopic cholecystectomy MedDRA version: 9.1 Level: LLT Classification code 10008611 Term: Cholecystectomy

Interventions

Trade Name: Precedex Product Name: Precedex Pharmaceutical Form: Injection* Trade Name: Rapifen Product Name: Rapifen Pharmaceutical Form: Injection* Trade Name: Dolsin Product Name: Dolsin Pharmac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients (18+ years) scheduled for laparoscopic cholecystectomy, absent or mild complicating disease without limitation of function of any organ system (ASA classification 1-2), written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Inability to understand postoperative questionnaire, know allergy to any drug used in the study, limited organ function (classification ASA 3-5), emergency, psychiatric medication, gravidity, lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: Improvement of cardiovascular stability during surgery Suppression of adverse (anxiety, pain, cardiovascular, ventilatory) perioperative events;Secondary Objective: Rapid recovery after surgery Prolonged postoperative analgesia Suppression of postoperative nausea and vomiting;Primary end point(s): New type of premedication with the following effects -good cardiovascular stability -minimal effect on ventilation -relief of anxiety -rapid recovery after anaesthesia -prolonged postoperative analgesia -suppression of postoperative nausea and vomiting	—

Measure

Time frame

Main Objective: Improvement of cardiovascular stability during surgery Suppression of adverse (anxiety, pain, cardiovascular, ventilatory) perioperative events;Secondary Objective: Rapid recovery after surgery Prolonged postoperative analgesia Suppression of postoperative nausea and vomiting;Primary end point(s): New type of premedication with the following effects -good cardiovascular stability -minimal effect on ventilation -relief of anxiety -rapid recovery after anaesthesia -prolonged postoperative analgesia -suppression of postoperative nausea and vomiting

—

Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026