Skip to content

Opioid Free Anesthesia in Abdominal Laparoscopic Surgery

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06394375
Enrollment
74
Registered
2024-05-01
Start date
2023-07-01
Completion date
2023-12-31
Last updated
2024-05-03

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

Conditions

Abdominal Surgery, Laparoscopic Surgery

Keywords

Abdominal surgery, Laparoscopic surgery, Dexmedetomidine, Opioid free anesthesia

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.

Interventions

DRUGDexmedetomidine

OFA

DRUGFentanyl

Given as analgesia in opioid balanced anesthesia (control) group

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Participants are randomized into two groups for control (opioid balanced anesthesia) or intervention (opioid free anesthesia)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressureIntraoperativeblood pressure, both systolic and diastolic measured with non invasive blood pressure monitoring
Heart rateIntraoperativeHeart rate

Secondary

MeasureTime frameDescription
Pain score24 hourNumerical rating scale 0-10 is used to quantify pain score postoperatively, with higher value indicating more pain experienced by the patient
Total consumption of OpioidIntraoperativeTotal consumption of fentanyl as rescue analgesia in mcg
quantium nociception index (qNOX)IntraoperativeqNox 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)
EphedrineintraoperativeTotal consumption of ephedrine to increase heart rate and blood pressure in mg

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026