Two-channel IV-PCA With Dexmedetomidine

NCT05672225 | Recruiting DMC

• 1 other identifier: 2022GR0414
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Analgesia, Patient-Controlled; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Fentanyl consumption during 24 hours

  Cumulative consumption of fentanyl during 24 hours

  24 hours after surgery

Secondary Outcomes (7)

• Additional analgesic consumption at post-anesthesia care unit

  1 hour after surgery

• Fentanyl consumption during 1,6,48 hours

  1,6,24,48 hours after surgery

• Pain scores at 1,6,24,48 hours

  1,6,24,48 hours after surgery

• Rescue analgesic consumption at 1,6,24,48 hours

  1,6,24,48 hours after surgery

• Adverse events during 1,6,24,48 hours

  1,6,24,48 hours after surgery

Study Arms (2)

Control group

ACTIVE COMPARATOR

Continuous channel: normal saline 100ml, 2ml/h (fixed rate) Selector \& Bolus channel: fentanyl 20mcg/kg (Total 50ml with normal saline), bolus 1ml/10min lock-out

Drug: Control

Dexmedetomidine group

EXPERIMENTAL

Continuous channel: dexmedetomidine 10mcg/kg (Total 100ml with normal saline), 2ml/h (fixed rate) Selector \& Bolus channel: fentanyl 20mcg/kg (Total 50ml with normal saline), bolus 1ml/10min lock-out

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group

Dexmedetomidine group

Control DRUG

Normal saline 2ml/hr administration via continuous channel in the experimental group

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who was scheduled for laparoscopic major abdominal surgery (Gastrectomy, Hepatectomy, Colectomy, Pancreatectomy) under general anesthesia
• Aged ≥ 20 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Seok Kyeong Oh, M.D., Ph.D

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seok Kyeong Oh, M.D., Ph.D

CONTACT

82-2-2626-3237; nanprayboy@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: February 7, 2023
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)