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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03393403
Enrollment
90
Registered
2018-01-08
Start date
2017-12-23
Completion date
2020-12-31
Last updated
2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Pain, Postoperative

Keywords

Subcostal transversus abdominis plane block

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.

Interventions

DRUGDexmedetomidine

0.5mcg/kg intravenous(IV)continuous infusion for 30 minutes, or 0.5mcg/kg adding to local anesthetic for subcostal TAP block

0.125ml/kg intravenously infusion in Dexmedetomidine\_adj group and control group

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
analgesic effect - pain intensitypostoperative 3 dayspostoperative acute pain intensity (numerical rating scale, NRS, 0-10)

Secondary

MeasureTime frameDescription
sedative effectpostoperative 2 hoursemergence agitation in post-anesthesia care unit (Riker sedation-agitation scale, 1-7)
analgesic effect - opioid consumptionpostoperative 3 daysFentanyl consumption(mcg) via patient-control analgesia (PCA) pump

Countries

Taiwan

Contacts

Primary ContactMiao-Pei Su, M.D.
cavia0803@hotmail.com0088673121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026