Ignite Creation Date:
2025-12-24 @ 7:31 PM
Ignite Modification Date:
2026-04-11 @ 1:03 AM
Study NCT ID:
NCT03393403
Status:
UNKNOWN
Last Update Posted:
2018-01-12
First Post:
2017-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effect of Intravenous and Perineural Dexmedetomidine in Gastric Cancer Surgery
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: