Opioid Free Anesthesia in Abdominal Laparoscopic Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery; Abdominal Surgery
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Fentanyl

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Cental National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opioid free anesthesia; 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	Drug: Dexmedetomidine; OFA
Active Comparator: Opioid balanced anesthesia; 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	Drug: Fentanyl; Given as analgesia in opioid balanced anesthesia (control) group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate	Intraoperative
Blood pressure	blood pressure, both systolic and diastolic measured with non invasive blood pressure monitoring	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total consumption of Opioid	Total consumption of fentanyl as rescue analgesia in mcg	Intraoperative
quantium nociception index (qNOX)	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)	Intraoperative
Ephedrine	Total consumption of ephedrine to increase heart rate and blood pressure in mg	intraoperative
Pain score	Numerical rating scale 0-10 is used to quantify pain score postoperatively, with higher value indicating more pain experienced by the patient	24 hour

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 20, 2024
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Dexmedetomidine; Opioid free anesthesia; Abdominal surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: IndonesiaU23061029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No