Opioid Free Anesthesia in Abdominal Laparoscopic Surgery

Phase 2

Completed

• Conditions: Laparoscopic Surgery; Abdominal Surgery
• Interventions: Drug: Fentanyl; Drug: Dexmedetomidine

• Registration Number: NCT06394375
• Lead Sponsor: Indonesia University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31
• Study First Submitted: 2024-04-20
• Study First Submitted QC: 2024-04-27
• Status Verified: 2024-05
• Study First Posted: 2024-05-01
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid balanced anesthesia	Fentanyl	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
Opioid free anesthesia	Dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
Heart rate	Intraoperative	Heart rate
Blood pressure	Intraoperative	blood pressure, both systolic and diastolic measured with non invasive blood pressure monitoring

Secondary Outcome Measures

Name	Time	Method
Total consumption of Opioid	Intraoperative	Total consumption of fentanyl as rescue analgesia in mcg
quantium nociception index (qNOX)	Intraoperative	qNox score is measured at specific time points, available from Conox monitor measurement since the start of the procedure. Higher value indicates more nociception experienced by the patient (0-100)
Ephedrine	intraoperative	Total consumption of ephedrine to increase heart rate and blood pressure in mg
Pain score	24 hour	Numerical rating scale 0-10 is used to quantify pain score postoperatively, with higher value indicating more pain experienced by the patient

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia