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Clinical Trials/NCT03393403
NCT03393403
Unknown
Not Applicable

Comparison of the Effect of Intravenous Continuous Dexmedetomidine Infusion and Dexmedetomidine as a Local Anesthetic Adjuvant in Subcostal Transverse Abdominis Plane Block in Patients Undergoing Gastric Cancer Surgery

Kaohsiung Medical University Chung-Ho Memorial Hospital1 site in 1 country90 target enrollmentStarted: December 23, 2017Last updated:

Overview

Phase
Not Applicable
Enrollment
90
Locations
1
Primary Endpoint
analgesic effect - pain intensity

Overview

Brief Summary

Using random case assignment to investigate the analgesic and sedative effect of intravenous dexmedetomidine and dexmedetomidine as a local anesthetic adjuvant in ultrasound-guided subcostal TAP block in gastric cancer patient undergoing gastrectomy or partial gastrectomy.

Detailed Description

The process of the experiment (brief describe) The participant patients will be randomly allocated into three groups: the intravenous dexmedetomidine group (Dex_iv group), dexmedetomidine adding to local anesthetic as an adjuvant for subcostal TAP block (Dex_adj group), and Control group. All patients receive gastrectomy or partial gastrectomy in general anesthesia as standard. Thirty minutes before the end of surgery, the patients in Dex_iv group receive 0.5mcg/kg dexmedetomidine infusion for 30 minutes, while the patients in Dex_adj group and control group receive 0.125ml/kg 0.9% normal saline IV infusion for 30 minutes. All patients have ultrasound-guided TAP block single injection after the end of surgery and before the tracheal tube extubation. The block agents in Dex_adj group is 40 ml of 0.375% ropivacaine with 0.5mcg/kg dexmedetomidine, while in Dex_iv group and control group are only 40ml of 0.375% ropivacaine. The IV PCA pump will be set up before patients awaken in the post-anesthesia care unit. All patients are assessed for the signs of emergence agitation with Riker sedation-agitation scale in the post-anesthesia care unit. The numerical rating scale (NRS) for pain intensity assessment, the opioid consumption via IV PCA pump, and the patients satisfaction will be documented for postoperative 3 days for the impact evaluation of dexmedetomidine in postoperative analgesia in patients undergoing gastric cancer surgery with subcostal TAP block.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • gastric cancer patients undergoing gastrectomy or partial gastrectomy, who receive ultrasound-guided subcostal TAP block and PCA for postoperative analgesia

Exclusion Criteria

  • surgery involved other visceral organ (eg. combined splenectomy or partial hepatectomy), patients with histories of adverse drug reaction to dexmedetomidine, bradycardia (baseline heart rate \<60 beats/min), any type of atrioventricular block in electrocardiogram (EKG), heart failure, significant renal or hepatic impairment, severe bronchopulmonary disease, any coagulant disorder, and pregnant or breast-feeding woman.

Arms & Interventions

Dexmedetomidine_iv group

Experimental

Dexmedetomidine 0.5mcg/kg (diluted in normal saline) intravenously infusion for 30min

Intervention: Dexmedetomidine (Drug)

Dexmedetomidine_adj group

Experimental

Dexmedetomidine 0.5mcg/kg (adding to local anesthetic) perineural single bolus for subcostal TAP block 0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min

Intervention: Dexmedetomidine (Drug)

Dexmedetomidine_adj group

Experimental

Dexmedetomidine 0.5mcg/kg (adding to local anesthetic) perineural single bolus for subcostal TAP block 0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min

Intervention: 0.9% Sodium-chloride (Drug)

Control group

Active Comparator

0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min No dexmedetomidine use

Intervention: 0.9% Sodium-chloride (Drug)

Outcomes

Primary Outcomes

analgesic effect - pain intensity

Time Frame: postoperative 3 days

postoperative acute pain intensity (numerical rating scale, NRS, 0-10)

Secondary Outcomes

  • sedative effect(postoperative 2 hours)
  • analgesic effect - opioid consumption(postoperative 3 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

KMUHIRB-F(II)-20170001

Physician

Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Sites (1)

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