Opioid Free Anesthesia in Abdominal Laparoscopic Surgery

NCT06394375 | Completed Phase 2

• 1 other identifier: IndonesiaU23061029
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Laparoscopic Surgery; Abdominal Surgery

Keywords

Abdominal surgery; Laparoscopic surgery; Dexmedetomidine; Opioid free anesthesia

Outcome Measures

Primary Outcomes (2)

• Blood pressure

  blood pressure, both systolic and diastolic measured with non invasive blood pressure monitoring

  Intraoperative

• Heart rate

  Heart rate

  Intraoperative

Secondary Outcomes (4)

• Total consumption of Opioid

  Intraoperative

• quantium nociception index (qNOX)

  Intraoperative

• Ephedrine

  intraoperative

• Pain score

  24 hour

Study Arms (2)

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

Drug: Dexmedetomidine

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

Drug: Fentanyl

Interventions

Dexmedetomidine DRUG

OFA

Opioid free anesthesia

Fentanyl DRUG

Given as analgesia in opioid balanced anesthesia (control) group

Opioid balanced anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: May 1, 2024
• Study Start: July 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

ID (1)