Comparison of the Effect of Intravenous and Perineural Dexmedetomidine in Gastric Cancer Surgery

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03393403
• Other study ID #: KMUHIRB-F(II)-20170001
• Status: Recruiting
• Phase: N/A
• First received: December 27, 2017
• Last updated: January 10, 2018
• Start date: December 23, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2018
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Miao-Pei Su, M.D.
• Phone: 0088673121101
• Email: cavia0803[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Pain, Postoperative
• Stomach Neoplasms

Intervention

Drug:
• Dexmedetomidine
0.5mcg/kg intravenous(IV)continuous infusion for 30 minutes, or 0.5mcg/kg adding to local anesthetic for subcostal TAP block
• 0.9% Sodium-chloride
0.125ml/kg intravenously infusion in Dexmedetomidine_adj group and control group

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesic effect - pain intensity	postoperative acute pain intensity (numerical rating scale, NRS, 0-10)	postoperative 3 days
Secondary	sedative effect	emergence agitation in post-anesthesia care unit (Riker sedation-agitation scale, 1-7)	postoperative 2 hours
Secondary	analgesic effect - opioid consumption	Fentanyl consumption(mcg) via patient-control analgesia (PCA) pump	postoperative 3 days