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

NCT ID: NCT03393403

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-23
• Study Completion Date: 2020-12-31

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.

Conditions

Gastric Cancer; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine_iv group

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

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Dexmedetomidine_adj group

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

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Control group

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

Group Type: ACTIVE_COMPARATOR

0.9% Sodium-chloride

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

0.9% Sodium-chloride

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

Intervention Type: DRUG

Other Intervention Names

Precedex

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

KMUHIRB-F(II)-20170001

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miao-Pei Su, M.D.

Role: PRINCIPAL_INVESTIGATOR

Physician

Locations

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Miao-Pei Su, M.D.

Role: CONTACT

cavia0803@hotmail.com

0088673121101 ext. 7033

Facility Contacts

Miao-Pei Su, M.D.

Role: primary

Other Identifiers

KMUHIRB-F(II)-20170001

Identifier Type: -

Identifier Source: org_study_id