---
title: Opioid Free Anesthesia in Abdominal Laparoscopic Surgery
nct_id: NCT06394375
overall_status: COMPLETED
phase: PHASE2, PHASE3
sponsor: Indonesia University
study_type: INTERVENTIONAL
primary_condition: Laparoscopic Surgery
countries: Indonesia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06394375.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06394375"
ct_last_update_post_date: 2024-05-03
last_seen_at: "2026-05-12T06:28:10.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Opioid Free Anesthesia in Abdominal Laparoscopic Surgery

**Official Title:** Effectiveness of Opioid Free Anesthesia Using Dexmedetomidine Inhibiting Nociception in Abdominal Laparoscopic Surgery

**NCT ID:** [NCT06394375](https://clinicaltrials.gov/study/NCT06394375)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2, PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 74
- **Lead Sponsor:** Indonesia University
- **Conditions:** Laparoscopic Surgery, Abdominal Surgery
- **Start Date:** 2023-07-01
- **Completion Date:** 2023-12-31
- **CT.gov Last Update:** 2024-05-03

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Opioid free anesthesia** (EXPERIMENTAL) — 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
- **Opioid balanced anesthesia** (ACTIVE_COMPARATOR) — 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

## Interventions

- **Dexmedetomidine** (DRUG) — OFA
- **Fentanyl** (DRUG) — Given as analgesia in opioid balanced anesthesia (control) group

## Primary Outcomes

- **Blood pressure** _(time frame: Intraoperative)_ — blood pressure, both systolic and diastolic measured with non invasive blood pressure monitoring
- **Heart rate** _(time frame: Intraoperative)_ — Heart rate

## Secondary Outcomes

- **Total consumption of Opioid** _(time frame: Intraoperative)_
- **quantium nociception index (qNOX)** _(time frame: Intraoperative)_
- **Ephedrine** _(time frame: intraoperative)_
- **Pain score** _(time frame: 24 hour)_

## Locations (1)

- Cipto Mangunkusumo Cental National Hospital, Jakarta, DKI Jakarta, Indonesia

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cipto mangunkusumo cental national hospital|jakarta|dki jakarta|indonesia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06394375.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06394375*  
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