Opioid Free Anesthesia in Abdominal Laparoscopic Surgery

Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06394375
• Other study ID #: IndonesiaU23061029
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery
• Laparoscopic Surgery

Intervention

Drug:
• Dexmedetomidine
OFA
• Fentanyl
Given as analgesia in opioid balanced anesthesia (control) group

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	blood pressure, both systolic and diastolic measured with non invasive blood pressure monitoring	Intraoperative
Primary	Heart rate	Heart rate	Intraoperative
Secondary	Total consumption of Opioid	Total consumption of fentanyl as rescue analgesia in mcg	Intraoperative
Secondary	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
Secondary	Ephedrine	Total consumption of ephedrine to increase heart rate and blood pressure in mg	intraoperative
Secondary	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