- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01657812
A Comparison of Dexmedetomidine and Epidural Anesthesia Under General Anesthesia in Patients Undergoing Gastrectomy
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Anhui
-
HeFei, Anhui, China, 230601
- Recruiting
- The Second Affiliated Hospital of Anhui Medical University
-
Contact:
- Yun Li, doctor
- Email: yunli_001@yahoo.com.cn
-
Contact:
- Ye Zhang, doctor
- Email: zhangye_hassan@yahoo.com.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consent
- ASA 1-2
- No contraindication to epidural or dexmedetomidine
- First time surgery for current conditions
- Not on chronic pain medications or sedative
Exclusion Criteria:
.The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
- The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
- The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine
- The subject has know central nervous system disease or neurological impairment
- The subject is an ASA classification of 3 or greater
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: dexmedetomidine
Drug:dexmedetomidine,dexmedetomidine 1.0μg/kg intravenous injection within 15 minutes before the induction of general anesthesia and followed by Dex 0.4μg/kg/h until 40min before the end of surgery
|
Dexmedetomidine, an alpha 2 agonist provides sedative, anxiolytic, anti-shivering, analgesic, and anaesthetic sparing effect. In addition α2-adrenoceptor agonists reduce central sympathetic outflow and attenuate the stress response associated with surgery.Unlike epidural anaesthesia, dexmedetomidine is easy to administer and no potential for neurological damage. Date suggest that the dexmedetomidine reduces the stress response of surgery to the similar extent to epidural anaesthesia when used in conjunction with a standard general anaesthesia for abdominal surgery.
Other Names:
|
ACTIVE_COMPARATOR: epidural
Epidural:continuous epidural block (T8-9) 4 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery
|
Dexmedetomidine, an alpha 2 agonist provides sedative, anxiolytic, anti-shivering, analgesic, and anaesthetic sparing effect. In addition α2-adrenoceptor agonists reduce central sympathetic outflow and attenuate the stress response associated with surgery.Unlike epidural anaesthesia, dexmedetomidine is easy to administer and no potential for neurological damage. Date suggest that the dexmedetomidine reduces the stress response of surgery to the similar extent to epidural anaesthesia when used in conjunction with a standard general anaesthesia for abdominal surgery.
Other Names:
|
PLACEBO_COMPARATOR: control
Drug: normalsaline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiovascular Parameters: Heart rate, blood pressure and ECG ;Parameters on stress response:norepinephrine (NE), epinephrine ( E)
Time Frame: pre-administration of Dex or epidural anesthesia,intubation, 3 min after intubation , immediately after incision, immediately after the initiation of celiac exploration, 1 h after operation,extubation
|
pre-administration of Dex or epidural anesthesia,intubation, 3 min after intubation , immediately after incision, immediately after the initiation of celiac exploration, 1 h after operation,extubation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anesthetics consumption: propofol and remifentanil consumption
Time Frame: during operation
|
during operation
|
anesthesia recovery :the time of eye opening, side effects such as nausea, vomiting and post-anaesthetic shivering, VAS, first exhaust time, hospitalization time
Time Frame: up to 48 hours
|
up to 48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ye Zhang, Ph.D, The Second Hospital of Anhui Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- 3869480
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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