Effectiveness of Opioid Free Anesthesia Using Dexmedetomidine Inhibiting Nociception in Abdominal Laparoscopic Surgery

IndonesiaU23061029

Effectiveness of opioid free anesthesia using Dexmedetomidine to inhibit nociception in abdominal laparoscopic surgery

2023-07-01

2023-10-31

2023-12-31

Completed

Early phase I

74

Inclusion criteria * Patients undergoing abdominal laparoscopic surgery (digestive, urologic, gynecologic surgery) with general anesthesia * BMI \<= 30 kg/m2 * Assessed with ASA 1-3 * Willing to participate in this study Exclusion Criteria: * Allergy to dexmedetomidine * Heart rate \< 60 or systolic blood pressure \<100 mmHg * Severe cardiovascular, uncontrolled hypertension (stage 2) or hepatic or renal disorder * Sepsis * Pregnancy * Difficult airway Drop out Criteria: * Intraoperative emergency * Convert to open laparatomy * Decided to withdraw from the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized into two groups for control (opioid balanced anesthesia) or intervention (opioid free anesthesia)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 74, 'type': 'ACTUAL'}}

2024-05-03