Gastric CancerNCT03393403
Comparison of the Effect of Intravenous and Perineural Dexmedetomidine in Gastric Cancer Surgery
A study testing Dexmedetomidine and 0.9% Sodium-chloride in people with Gastric Cancer and Pain, Postoperative, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Cancer, Pain, Postoperative
- What is being tested?
- Dexmedetomidine and 0.9% Sodium-chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Dec 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gastric cancer patients undergoing gastrectomy or partial gastrectomy, who receive ultrasound-guided subcostal TAP block and PCA for postoperative analgesia
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City
Miao-Pei Su, M.D.
About this study
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
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.
Read the 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
- Being tested
- Dexmedetomidine, 0.9% Sodium-chloride
- Keywords
- Subcostal transversus abdominis plane block
- Medical subject headings
- Stomach Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
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-chlorideDrug
0.125ml/kg intravenously infusion in Dexmedetomidine_adj group and control group
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine_iv group | Experimental | Dexmedetomidine 0.5mcg/kg (diluted in normal saline) intravenously infusion for 30min Receives: Drug: Dexmedetomidine |
| Dexmedetomidine_adj group | Experimental | 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 Receives: Drug: Dexmedetomidine; Drug: 0.9% Sodium-chloride |
| Control group | Active comparator | 0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min No dexmedetomidine use Receives: Drug: 0.9% Sodium-chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic effect - pain intensity
postoperative acute pain intensity (numerical rating scale, NRS, 0-10)
Measured: postoperative 3 days
Secondary outcomes (2)
sedative effect
emergence agitation in post-anesthesia care unit (Riker sedation-agitation scale, 1-7)
Measured: postoperative 2 hours
analgesic effect - opioid consumption
Fentanyl consumption(mcg) via patient-control analgesia (PCA) pump
Measured: postoperative 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start23 Dec 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KMUHIRB-F(II)-20170001, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Miao-Pei Su, M.D., Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393403
- Sponsor's protocol ID
- KMUHIRB-F(II)-20170001
- Status last verified
- Jan 2018
- First submitted
- 27 Dec 2017
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03393403
- Acronym / sponsor ID
- KMUHIRB-F(II)-20170001
- Conditions
- Gastric Cancer, Pain, Postoperative
- Keywords
- Subcostal transversus abdominis plane block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 23 Dec 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine_iv group | Experimental | Drug: DexmedetomidineDexmedetomidine 0.5mcg/kg (diluted in normal saline) intravenously infusion for 30min |
| Dexmedetomidine_adj group | Experimental | Drug: Dexmedetomidine, Drug: 0.9% Sodium-chlorideDexmedetomidine 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 |
| Control group | Active comparator | Drug: 0.9% Sodium-chloride0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min No dexmedetomidine use |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- gastric cancer patients undergoing gastrectomy or partial gastrectomy, who receive ultrasound-guided subcostal TAP block and PCA for postoperative analgesia
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Precedex0.5mcg/kg intravenous(IV)continuous infusion for 30 minutes, or 0.5mcg/kg adding to local anesthetic for subcostal TAP block | Drug | Dexmedetomidine_adj group, Dexmedetomidine_iv group |
| 0.9% Sodium-chloride0.125ml/kg intravenously infusion in Dexmedetomidine_adj group and control group | Drug | Control group, Dexmedetomidine_adj group |
Primary outcome
analgesic effect - pain intensity
Time frame: postoperative 3 days
postoperative acute pain intensity (numerical rating scale, NRS, 0-10)
2 secondary outcomes
sedative effect
Time frame: postoperative 2 hours
analgesic effect - opioid consumption
Time frame: postoperative 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miao-Pei Su, M.D. principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and 0.9% Sodium-chloride in people with Gastric Cancer and Pain, Postoperative, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miao-Pei Su, M.D. (0088673121101 ext. 7033, cavia0803@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic effect - pain intensity (time frame: postoperative 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.