Two-channel IV-PCA With Dexmedetomidine

Dexmedetomidine Clinical Trial

Official title:

Effectiveness of Two-channel Intravenous Patient-controlled Analgesia With Dexmedetomidine on Postoperative Opioid Consumption After Major Laparoscopic Abdominal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672225
• Other study ID #: 2022GR0414
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Korea University Guro Hospital
• Contact: Seok Kyeong Oh, M.D., Ph.D
• Phone: 82-2-2626-3237
• Email: nanprayboy[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dexmedetomidine was administered in the 'selector' channel and fentanyl in the 'basic & bolus' channel of dual channel intravenous patient-controlled analgesia (IV-PCA) and the amount of opioid consumption was compared. In addition, intensity of pain, postoperative nausea/vomiting, and postoperative delirium was evaluated.

Description:

Bellomic® (Cebika, Uiwang-si, Gyeonggi-do, South Korea), a new IV-PCA device consisting of two separate drug pump channels, can be used in various ways and is expanding its scope of use. Unlike conventional IV-PCA devices, which have been used to mix and administer all drugs in one channel, the device can inject drugs separately in two channels. One channel (Selector & Bolus) allows the patient to control whether to take additional bolus medication by pressing the button with adjustable continuous infusion, while the other channel (Continuous) allows constant rate continuous infusion.

Dexmedetomidine is a selective alpha-2 agonist, which is widely used in intensive care unit management, surgery, and various procedures because it has the advantage of less respiratory suppression along with sedation/anesthesia and pain effects. It has been previously reported that postoperative pain, morphine usage, and nausea/vomiting can be reduced when used during/after surgery in addition to general anesthetic drugs. However, in terms of major abdominal surgery, there is no research related to the use of dexmedetomidine after surgery, even though a large amount of opioid agents are required due to severe acute pain.

Thus, the investigators planned a randomized controlled trial to investigate the effectiveness dexmedetomidine using dual-chamber IV-PCA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who was scheduled for laparoscopic major abdominal surgery (Gastrectomy, Hepatectomy, Colectomy, Pancreatectomy) under general anesthesia

• Aged = 20 years old

Exclusion Criteria:

• Body mass index =35 kg/m2

• American Society of Anesthesiologists physical status > 3

• Severe cardiovascular disorder

• Severe liver or renal dysfunction

• Preoperative dyspnea

• Contraindication to dexmedetomidine (preoperative severe bradycardia (Heart rate <50), atrioventricular block, allergy to dexmedetomidine)

• Preoperative use of opioid, anticonvulsant, antidepressant

Related Conditions & MeSH terms

• Analgesia, Patient-Controlled
• Dexmedetomidine

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group
• Control
Normal saline 2ml/hr administration via continuous channel in the experimental group

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fentanyl consumption during 24 hours	Cumulative consumption of fentanyl during 24 hours	24 hours after surgery
Secondary	Additional analgesic consumption at post-anesthesia care unit	Opioid, NSAID, or acetaminophen consumption	1 hour after surgery
Secondary	Fentanyl consumption during 1,6,48 hours	Cumulative consumption of fentanyl during 1,6,48 hours	1,6,24,48 hours after surgery
Secondary	Pain scores at 1,6,24,48 hours	11-pointed numerical rating scale pain score (0 [no pain]-10 [Extreme pain])	1,6,24,48 hours after surgery
Secondary	Rescue analgesic consumption at 1,6,24,48 hours	Additional opioid, NSAID, or acetaminophen consumption	1,6,24,48 hours after surgery
Secondary	Adverse events during 1,6,24,48 hours	Nausea, vomiting, hypotension, sedation, respiratory depression, pruritus	1,6,24,48 hours after surgery
Secondary	Delirium during 1,6,24,48 hours	Confusion assessment method (CAM)-evaluated delirium	1,6,24,48 hours after surgery
Secondary	Satisfaction score at 24 hours	Satisfaction score evaluated with quality of recovery (QoR)-15 (0[poor] to 10[excellent]), 7-pointed Likert scale (1 [very dissatisfied]- 7[very satisfied])	24 hours after surgery