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OpenTrials
Completed

NCT Number: NCT06394375

Opioid Free Anesthesia in Abdominal Laparoscopic Surgery

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

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Key information

Conditions

Laparoscopic Surgery Abdominal Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

OFA

Fentanyl

Drug

Given as analgesia in opioid balanced anesthesia (control) group

Primary outcomes

  1. Blood pressure

    Time frame: Intraoperative

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

  2. Heart rate

    Time frame: Intraoperative

    Heart rate

Secondary outcomes

  1. Total consumption of Opioid

    Time frame: Intraoperative

    Total consumption of fentanyl as rescue analgesia in mcg

  2. quantium nociception index (qNOX)

    Time frame: 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)

  3. Ephedrine

    Time frame: intraoperative

    Total consumption of ephedrine to increase heart rate and blood pressure in mg

  4. Pain score

    Time frame: 24 hour

    Numerical rating scale 0-10 is used to quantify pain score postoperatively, with higher value indicating more pain experienced by the patient

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 1, 2024
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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