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

Kaohsiung Medical University

Status: Unknown

Conditions: Gastric Cancer; Pain, Postoperative

Treatments: Drug: Dexmedetomidine; Drug: 0.9% Sodium-chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03393403

KMUHIRB-F(II)-20170001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Dexmedetomidine_iv group

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

Dexmedetomidine_adj group

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

Drug: 0.9% Sodium-chloride

Control group

Active Comparator group

Description:

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

Treatment:

Drug: 0.9% Sodium-chloride