Opioid Free Anesthesia in Abdominal Laparoscopic Surgery

University of Indonesia (UI)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Laparoscopic Surgery; Abdominal Surgery

Treatments: Drug: Fentanyl; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06394375

IndonesiaU23061029

Details and patient eligibility

About

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

Full description

Abdominal laparoscopic surgery is one of the most common procedures worldwide, commonly facilitated with opioid balanced anesthesia or regional anesthesia. Despite being a controversy, there are issues that suggest opioid to have an influence in tumor recurrence. The investigators performed general anesthesia without opioid in laparoscopic abdominal surgery, and compared the hemodynamic instability, total consumption of fentanyl rescue, qNOX score, Ephedrine intraoperative, and Numerical Rating Scale.

Enrollment: 74 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Opioid free anesthesia

Experimental group

Description:

Patients in this group are given a combination of Dexmedetomidine, Lidocaine, Propofol, Sevoflurane, Rocuronium for induction and maintenance of general anesthesia. They are given rescue analgesia (fentanyl) when required, and Ephedrine as needed. Patients were monitored using standard ASA monitoring and Connox. Post operative pain score was assessed with NRS

Treatment:

Drug: Dexmedetomidine

Opioid balanced anesthesia

Active Comparator group

Description:

Patients in this group are given a combination of Opioid (Fentanyl), Lidocaine, Propofol, Sevoflurane, Rocuronium for induction and maintenance of general anesthesia. They are given Ephedrine as needed. Patients were monitored using standard ASA monitoring and Connox. Post operative pain score was assessed with NRS

Treatment:

Drug: Fentanyl